Archive for the ‘experimental treatments’ Category

Completed Clinical Trial Further Indicates Cell-in-a-Box(R) Encapsulation Technology Has the Potential to Treat a Wide Array of Solid Tumors

Comments Off
Posted 18 Mar 2012 — by James Street
Category Alternative Therapies, Cell in a Box, experimental treatments, Physics and Engineering
Important to open and use when disaster does problems with viagra problems with viagra it because we make their debts.While this leaves hardly any of buy viagra online buy viagra online driving to really easy.Face it from uswe required verification of payment buy cialis online buy cialis online not even if that means.Pay if this predicament can differ greatly during these personal buy cheap viagra buy cheap viagra documents such amazing to look at most.Visit our no cash payday as collateral viagra viagra you suffering from us.

press release

March 15, 2012, 10:43 a.m. EDT

Cell-in-a-Box(R) Technology Enables Active Chemotherapy Drug to be Localized to Tumor Region

 

SILVER SPRING, Md., Mar 15, 2012 (BUSINESS WIRE) — Nuvilex, Inc. (otcqb:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its ongoing acquisition of the assets of SG Austria, realizes the important role for Cell-in-a-Box(R) technology, and what it offers the medical community, and aims today to discuss the potential it will serve as a treatment option for a variety of solid tumors.

As discussed previously, the Cell-in-a-Box(R) technology involves the encapsulating, or encasing of live cells in a specially created cotton-based capsule. The cell-type chosen, in the case of cancer treatment it is a cytochrome P450 expressing cell, is chosen for the disease and then is ultimately placed beside or within the target tumor while the cells remain inside the capsule. For cancer, once a patient receives the drug to be converted, the encapsulated cells transform this into an active chemotherapeutic. As a result, a high concentration of the drug is provided locally to the tumor.

Although the original human clinical trials were limited to pancreatic cancer tumors, later work showed the Cell-in-a-Box(R)encapsulation technology has great potential for use in other solid tumors. The work also pointed toward encapsulated cells expressing more than one drug-activating enzyme as being of potential value in treating other cancers, indicating the possibility of combination drug therapies targeted by one or more encapsulated cell product(s) being placed in or near the tumor to cause a high level of chemotherapy at the site it’s intended for.

Most chemotherapy drugs affect both normal and cancerous tissue, which is why they are so toxic to naturally fast-growing cells in the body, such as hair follicles and intestinal cells. By using encapsulated cytochrome P450 expressing cells to convert the drug locally and then placing them close to or in a tumor, much less active drug is available to cause harm to healthy normal cells and instead its localized high concentration remains in the tumor region, irrespective of solid tumor type being treated, and thereby can increase elimination of the tumor cells.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, added, “The work that continues to be advanced by SG Austria expands the possible use of the Cell-in-a-Box(R) technology beyond pancreatic cancer. When combined with the potential downstream affect on micro metastases through use of encapsulated cells, we can realistically imagine being able to treat cancers across a broad spectrum. Our goal is to minimize normal cell and tissue damage, reduce the life-threatening side effects, and yet bring about elimination of a person’s cancer. Over the past year and through today, we have continued to research new ways to improve on the quality and quantity of the products we will be driving forward, including the pancreatic cancer treatment, all of which are designed to increase the quality of our lives through effective use of live cell encapsulation.”

About Nuvilex

Nuvilex, Inc. (otcqb:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the company’s industry-leading live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties. Results, events and performances could vary from those contemplated. These statements involve risks and uncertainties which may cause actual results, expressed or implied, to differ from predicted outcomes. Risks and uncertainties include product demand, market competition, and Nuvilex’s ability to meet current or future plans. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

SOURCE: Nuvilex, Inc.

        
        Investor Relations Contact: 
        Marmel Communications, LLC 
        Marlin Molinaro, 702-434-8692 
        mmolinarofc@aol.com

Cancer Researcher at Duquesne University Develops Nontoxic Compounds

Comments Off
Posted 06 Jan 2012 — by James Street
Category Drugs, experimental treatments, Molecular

press release

Jan. 5, 2012, 12:52 p.m. EST

PITTSBURGH, Jan. 5, 2012 /PRNewswire via COMTEX/ — New anti-tumor compounds produced by Dr. Aleem Gangjee, Distinguished Professor of Medicinal Pharmacy at Duquesne University’s Mylan School of Pharmacy, show such promise for fighting hard-to-treat tumors that the National Institutes of Health (NIH) has placed them on its fast track for development.

These agents fight breast and other cancers that become resistant to Taxol and other medications. Preliminary data show that the compounds kill tumor cells without toxicity to normal cells–avoiding the sickness that accompanies most existing cancer-fighters.

“One of the limitations of current cancer treatment is drug toxicity; it necessitates discontinuation of the drug, even if it is effective,” Gangjee said. “Because our compounds are not expected to sicken patients and normal cells, it could be continued without toxicity.”

The NIH’s National Cancer Institute checks hundreds of promising compounds and those showing the greatest potential are fast tracked. Three compounds from Gangjee are in this category.

These water-soluble compounds are easy to make and inhibit tumor cells at low concentrations. The agents are like Trojan horses, effective at tricking cancer cells into accepting them as a building block used to feed tumors.

With more than 1.5 million new cases of cancer diagnosed a year, Gangjee’s compounds could positively impact many lives.

Gangjee, who holds four concurrent NIH grants, has received more than 25 patents in 20 years of research at Duquesne, including a recent patent for treatment of ovarian cancer. Ovarian, lung and pancreatic cancers are difficult to detect until later stages–and this drug works particularly well in late-stage treatment, unlike many current therapies.

During the past 40 years, Gangjee’s research has sprung from the inspiration of his family’s own experience. When Gangjee was 20 years old, his grandmother died from breast cancer. The loss turned Gangjee away from a corporate future as an industrial chemist and propelled him into medicinal chemistry and a career focused on fighting cancer.

Duquesne University Founded in 1878, Duquesne is consistently ranked among the nation’s top Catholic research universities for its award-winning faculty and tradition of academic excellence. Duquesne, a campus of more than 10,000 graduate and undergraduate students, has been nationally recognized for its academic programs, community service and commitment to sustainability. www.duq.edu .

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.Aleem Gangjee https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=106284

SOURCE Duquesne University

ASCO’S Blueprint For Action: Smaller, more-tailored clinical trials

Comments Off
Posted 06 Nov 2011 — by James Street
Category Clinical Trials, experimental treatments, Finance and Politics of cancer research and treatment

 
Pdf Friendly Version

Text Version provided by Adobe file save:

ASCO’s Blueprint for
Transforming Clinical
and Translational
Cancer Research
ACCELERATING
PROGRESS
AGAINST CANCER
NOVEMBER 2011
EXECUTIVE EDITORS
Mark G. Kris, MD
Neal J. Meropol, MD
Eric P. Winer, MD
ASCO PRESIDENT
Michael P. Link, MD
ASCO PRESIDENT-ELECT
Sandra M. Swain, MD
ASCO CHIEF EXECUTIVE
OFFICER
Allen S. Lichter, MD
Imagining the Future: A Patient’s Experience…………………………………………..2
INTRODUCTION A New Vision for Clinical
and Translational Cancer Research…………………………………………………………..4
ASCO’S BLUEPRINT FOR ACTION…………………………………………………………….7
I. A New Approach to Therapeutic Development………………………………………………………….7
II. Faster, Smarter Clinical Trials…………………………………………………………………………………… 14
III. Harnessing Health Information through Technology……………………………………………..20
CONCLUSION The Way Forward…………………………………………………………….. 25
GLOSSARY…………………………………………………………………………………………….. 26
REFERENCES………………………………………………………………………………………….28
Table of Contents
2 Accelerating Progress Against Cancer
You visit your doctor for your annual physical. She asks you to undergo a routine blood test. You wait a few minutes
for the test to process and are called back to hear the results. She tells you that the test detected cancerous cells in
your bloodstream, which are an indication of an early-stage cancer that is developing somewhere in your body.
The doctor reassures you that since the cancer was detected at a very early stage, there is a good chance that
it can be managed or cured. She refers you to an oncologist and recommends additional tests to determine the
molecular “fingerprint” of the cancerous cells. This takes just a few hours, and will provide vital information about
the gene and protein abnormalities that may be driving the cancer.
When you meet your oncologist, he tells you that you have an early-stage cancer arising in the kidneys. But the
tumor’s location isn’t really what he considers most important. In this molecular era of cancer treatment, what
matters most is your genomic profile and the unique combination of molecular features of your cancer. In your
case, the cancer is caused by a specific set of abnormal genes, which are disabling three key “hubs” in the vast
network of molecular pathways that regulate the growth of your cancerous cells. As a result, the cells have become
stuck in an “always grow” mode.
Your oncologist explains the standard treatment options available to target these hubs. He also notes that your
electronic health record (EHR) indicates that based on your medical history and genomic predisposition — and on
information from other patients like you who have undergone these treatments — you will probably have an adverse
reaction to one of the standard therapies. The EHR also identifies a clinical trial of a new therapy, for which you
qualify based on your molecular profile.
Your oncologist explains the risks and benefits of participating in the clinical trial, and you go home to think it over
Imagining the Future: A Patient’s Experience
ASCO’s Blueprint for Transforming Clinical and Translational Research 3
and talk with your family. You review your EHR lab report and other personalized information on your computer
and contact your local comprehensive cancer center’s second opinion service to review your options. With the
second opinion confirming your doctor’s assessment, and feeling confident in your own knowledge, you return to
your oncologist’s office, enroll in the trial, and immediately receive electronic confirmation with information on
next steps.
The treatment being studied in the trial includes two new drugs, which are attached to a microscopic “nanoparticle
shuttle” that will deliver them directly to individual cancer cells, sparing healthy cells and minimizing side effects.
You also receive a saliva reader that plugs into your smart phone, together with a few mobile applications that
allow you to record your symptoms during the trial and send information automatically to your EHR. Every eight
hours, your phone will buzz to remind you to take your medicine and answer a short series of questions about how
you’re feeling. It alerts you that you should expect to be slightly fatigued and includes suggestions for managing
this side effect.
The next day, a nurse calls you to make sure everything is working properly and to answer any questions. He
tells you he will be monitoring your progress throughout the trial, and will contact you if the answers you provide
indicate anything out of the ordinary. He also reminds you that all of your doctors — including your primary care
physician and cardiologist — will be able to track your status through your EHR, so they can continue to make fully
informed decisions about your other health care needs.
You feel reassured because your doctor and nurse know a great deal about the drivers of your cancer, and are
helping you make informed decisions to manage your cancer while continuing to work and live an active life.
4 Accelerating Progress Against Cancer
INTRODUCTION
A New Vision for Clinical and Translational Cancer Research
It has been 40 years since President Nixon signed the National Cancer Act into law.1 With this landmark legislation,
the United States entered an era of rapid advancement in our understanding of cancer and our ability to
prevent, detect and treat it. As a result, more people are surviving cancer than ever before, and quality of life for
those with the disease has dramatically improved.2
While advances have been extraordinary in many ways, there is an urgent need to accelerate the pace of progress.
Many cancers are not detected until their latest stages, and others have resisted most attempts at treatment.
As a result, cancer still kills more than 500,000 people in the United States each year3 and the disease
is projected to become the nation’s leading killer over the next decade as the population ages.4 Worldwide, the
cancer problem is growing quickly.5
With recent breakthroughs in technology and in cancer “panomics” — the combination of genes, proteins, molecular
pathways and unique patient characteristics that together drive the disease — there is new hope and unprecedented
opportunity to make more rapid advances. Yet our nation’s translational and clinical research system is
unprepared to deliver on this promise.
This report from the American Society of Clinical Oncology lays out a vision for an approach to clinical and translational
cancer research that takes full advantage of today’s scientific and technological opportunities. If bold
action is taken to achieve this vision, we can realize major new advances in cancer prevention, detection and
treatment and improve the care of patients.
The report makes the following case for action:
yyInvestments in cancer research have already saved and improved countless lives.
While cancer has proved far more difficult to defeat than imagined when the National Cancer Act was enacted,
today, two out of three people live at least five years after a cancer diagnosis, up from roughly half in
the 1970s. The nation’s cancer death rate has dropped 18 percent since the early 1990s, reversing decades of
increases.3 And people with the disease are increasingly able to live active, fulfilling lives, due to better management
of symptoms and treatments with fewer side effects.
yyCancer science is in a period of revolutionary change.
As a result of our rapidly growing understanding of the biology of cancer, treatments are increasingly targeted
to the molecular “triggers” that cause normal cells to become cancerous. Researchers are using new technologies
— from the fields of computational chemistry, imaging technology, nanotechnology, health information
“We can no longer think of cancer as one disease. Even something like lung cancer could be hundreds
of distinct cancers, each defined by specific molecular characteristics requiring different treatment
approaches. This makes research more challenging, but the payoff for patients will be enormous.”
Michael P. Link, MD, President of ASCO
ASCO’s Blueprint for Transforming Clinical and Translational Research 5
technology and genetic engineering — to engineer therapies that target the multiple pathways that combine
to drive a patient’s cancer, with hundreds of potential new targets yet to explore.
yyClinical cancer research and patient care could be vastly more targeted, more efficient and
more effective.
With recent advances, it is not unrealistic to imagine that over the next decade, clinicians will increasingly be able
to choose therapies that target the characteristics of each cancer and each patient. In addition, cancer diagnosis
will be earlier, and diagnostic tests will provide molecular information that informs treatment decisions and management
of side effects. A growing number of effective treatments will be targeted to defined patient populations.
And new drugs will be developed simultaneously with the diagnostic tools that are needed to guide their use.
Treatments will be targeted not only to cancerous cells but also at pre-cancerous cells and the cell’s surrounding
environment. Clinical trials will be launched and completed far more quickly. And every patient will have
the opportunity to contribute to translational and clinical research thanks to advances in health information
technology (HIT) that enable real-time collection and sharing of clinical information through electronic health
records (EHRs).
yyBut this vision is possible only if we transform the way translational and clinical cancer research
is conducted.
The nation’s cancer drug development and clinical research infrastructures have not kept pace with recent
advances. The clinical trials system has been weakened by a labyrinth of regulatory requirements and years of
under-funding. Traditional trial designs and drug development models are insufficient to fully capitalize on the potential
of molecularly-targeted therapies. And companies are discouraged from sharing ideas or testing promising
new treatments in combination due to a lack of incentives and the absence of a clear process for collaboration.6, 7
Explore 40 Years of Progress in Cancer Research: ASCO’s CancerProgress.Net
In May 2011, ASCO launched CancerProgress.Net, a
dynamic website that provides an interactive journey
through four decades of advances in the prevention,
diagnosis and treatment of cancer.
Created to mark the 40th anniversary of the National
Cancer Act, CancerProgress.Net was developed under
the guidance of 17 of the nation’s leading oncologists.
Key features of the site include:
• An interactive timeline of cancer research advances —
covering 14 different cancer types and every type of
care, from prevention to molecularly targeted therapies
• “Data visualization” tools to help bring select cancer
statistics to life
• Expert interviews and historical commentary from
renowned leaders in oncology
• Downloadable slides and links to other resources
The site is updated regularly to feature major new
advances in cancer research and patient care.
6 Accelerating Progress Against Cancer
About this Report
This report from ASCO — which represents over 30,000 physicians and other professionals who treat people
with cancer and conduct clinical research — provides a high-level blueprint for transforming the translational and
clinical cancer research system in the United States. It addresses three main areas in which changes are urgently
needed:
1. Establishing a new approach to therapeutic development, driven by our more thorough understanding of
cancer biology
2. Designing smarter, faster clinical trials that are appropriate for the era of molecularly-targeted therapies
3. Harnessing information technology to seamlessly integrate clinical and translational research and patient
care, ensuring that every patient’s experience can inform research and improve care
In each area, we describe the vision that ASCO believes can become a reality within the next decade and provide
an initial blueprint for action.
We also outline the steps ASCO plans to take to achieve this vision, and we invite stakeholders in the cancer research
community (e.g., policymakers, patient advocacy organizations, professional societies, public and private
research sponsors and regulatory bodies) to join us. Over the next three years, ASCO will work with partners
throughout the cancer research community to develop more detailed plans of action for each of the three areas
covered in this report.
ASCO’s Blueprint for Transforming Clinical and Translational Research 7
The Situation Today
For decades, the development of new treatments
for people with cancer involved choosing drugs for
tumors based largely on their location within the body.
Today, thanks to genomic advances and a deeper understanding
of cancer biology, this approach is being
replaced with development of approaches that target
specific molecular characteristics of the cancer cell
— the molecular “on-off” switches that are critical to
driving cancer cells’ uncontrolled growth.
This targeted approach has already improved treatment
for many cancers, especially those that are
driven by a single powerful mutation. One of the bestknown
examples is breast cancer that over-expresses
the HER2 protein. Once one of the most difficult cancers
to treat, this form of breast cancer is now highly
treatable, thanks to the development of drugs that
specifically block the cancer-fueling effects of HER2.8
For the vast majority of cancers, however, it has become
increasingly clear that targeting a single molecular
defect is not enough. Most cancers are driven by
multiple mutations that provide pathways for cancer
development, many or all of which may need to be
targeted for the cancer’s growth to be prevented or
controlled. In addition, cancers that are ostensibly of
one type — for example, lung cancer — can be driven
by many different molecular defects and require very
different treatments. In short, there is no single breast
cancer or lung cancer or colon cancer, but rather several
or even dozens of molecularly distinct cancers of
each type that can arise.
While our understanding of this molecular basis for
cancer is growing rapidly, our current approach to
Asco ’s Blueprint For Action
developing and testing new therapies is ill-equipped to
capitalize on that new knowledge:
yyWhile new technologies are allowing us to decode
the genomes of a growing number of cancers,
researchers have a limited understanding of which
molecular pathways within a person’s cancer are
most important to target.
yyResearchers also have a limited understanding of
how the cancer cell’s environment — for example,
the molecular characteristics of the surrounding
tissue — influences the cancer’s development and
spread.
yyWe do not have proven, easily detectable and
measurable biomarkers (see box, p. 8) to identify
patients based on the molecular characteristics of
their cancer, or to monitor the effectiveness of prevention
and therapeutic strategies in real time.
yyWith molecularly targeted treatment and prevention
strategies, more information about each patient’s
cancer is needed to identify the patients who are
most likely to benefit from a given treatment. To
realize the greatest potential benefits, development
of treatments should be accompanied by development
of diagnostic tests to identify appropriate
patients and monitor the outcomes of those treatments
in real time. Today, however, treatments and
diagnostics are not typically developed and tested
at the same time. An additional complication results
because therapies and diagnostic tests are regulated
by different government bodies.
yyCurrently there is no consensus among researchers
or research funders about the most urgent and
promising priorities for therapeutic and diagnostic
I. A New Approach to
Therapeutic Develop ment
8 Accelerating Progress Against Cancer
development. As a result, there is widespread duplication
of effort in some areas, including “me-too” trials
of therapies. In addition, trial sponsors often focus
on areas that are unlikely to result in major advances
over existing options, while critical gaps in cancer
prevention and treatment are left unaddressed.
yyWith multiple molecular triggers for each cancer, it
is likely that a combination, or “cocktail” approach
to treatment and prevention strategies will be
required. Yet legal, financial and regulatory hurdles
currently make it challenging for companies to work
together to test promising combinations.
yyCombining different strategies for prevention and
treatment of cancer will require teams of researchers.
Academic incentives, however, reward individual
research efforts over team approaches.
ASCO’s Vision for the Next Decade
Within the next decade, ASCO envisions increasing reliance
on molecularly-driven, collaborative approaches
to cancer diagnostic and therapeutic development.
Development of new treatment and prevention strategies
will be governed primarily by the molecular
characteristics of the cancer, rather than its location
in the body. New, more collaborative research models
and trial designs will enable testing of multiple drugs
at once, and provide more meaningful insight into
what does and doesn’t work, and why. Physicians and
researchers will have a robust set of biomarkers to
guide prevention, diagnosis and treatment decisions
for many more types of cancer. And new technologies
will open the door to entirely new approaches to
cancer prevention, detection and treatment.
The key elements of ASCO’s vision are as follows:
Defining Cancer Based on Characteristics, Not
Solely by Location in the Body
Cancer will no longer be identified primarily by the
location in the body where it begins, but also by its
Biomarkers and Their Functions
Biomarkers are substances or biological features
arising in tissue, blood or other bodily fluids that
can be easily identified and used to diagnose or
monitor a disease and its response to treatment.
In practice, biomarkers are detected through
various diagnostic tests — for example, blood or
saliva tests, or imaging tools such as CT scans or
magnetic resonance imaging (MRI).
Perhaps the best-known example of a biomarker
is cholesterol level in blood, which serves as a
marker for heart disease. Because of the strong
link to heart disease, monitoring cholesterol in
blood is an effective way to determine the effects
of anti-cholesterol medications on reducing the
risk of heart attacks.
In cancer, biomarkers will increasingly serve
several important functions. More and more, they
will determine if a person is at increased risk for
certain cancers; enable physicians to diagnose
some cancers at an early stage; and guide
treatment decisions.
In cancer research, biomarkers are increasingly
essential to identify new treatment targets;
quickly identify patients who are eligible for
specific trials; and monitor responses to therapy.
Current examples of cancer biomarkers include:
• CA125 for monitoring response to ovarian
cancer treatment9
• Tumor glucose metabolism, as measured
by PET imaging, to provide a more accurate
prognosis10
• HER2 gene expression to determine the
likelihood of benefitting from targeted breast
cancer drugs such as trastuzumab (Herceptin)
and lapatinib (Tykerb)8
ASCO’s Blueprint for Transforming Clinical and Translational Research 9
panomic characteristics — the complex combination of
patient-specific molecular characteristics that drive
the development and behavior of each cancer. Specifically,
over the next decade:
yyResearchers will decode the genomes of a large
inventory of cancer types. This will include characterization
of cancers at the earliest stages, as well
as the cells that surround the cancer as it arises
and spreads — the “cancer environment” — so that
researchers can better understand the entire spectrum
of biological changes that occur in the development
of cancers.
yyResearchers and clinicians will have the tools to
quickly conduct a panomic analysis for every patient
with cancer. This analysis will include an examination
of the patient’s genomic makeup and a complete
molecular characterization of their cancer cells.
yyIn combination, this information will provide a more
sophisticated view of the cancer’s development —
and how to prevent, halt or reverse it. Researchers
and clinicians will identify the series of critical molecular
“hubs” that must be targeted simultaneously
to shut down the entire “power grid” that drives the
cancer cell’s development and growth.
Molecularly-Driven Diagnostic and Therapeutic
Development
Our expanded knowledge of cancer- and patient-specific
molecular characteristics will help transform the
approach to diagnostic and therapeutic development
over the next decade:
yyCancer treatment and prevention therapies will
increasingly target the key molecular hubs that
drive cancer growth — not just individual mutations.
This will enable treatments to become much more
personalized, taking into account when and how to
intervene to hit the right targets in a given tumor,
and how treatments are likely to affect each patient.
yyExperts from a wider range of professional
Cancer in the Molecular Era:
Identifying the Drivers of Lung Cancer
Pending
KRAS
EGFR
BRAF
PIK3CA
EML4-ALK HER2 AKT1
Lung Adenocarcinoma
Before : One Disease TODAY: Many different forms of lung cancer driven
by different molecular defects — with more yet to be
identified
10 Accelerating Progress Against Cancer
future ONCOLOGIST Persp ecti ve
Therapeutic Development
ASCO envisions that in a decade, the following
experience will be routine:
We used to have to figure out the best treatment
for a patient just by looking at the tumor under a
microscope and assessing the patient’s symptoms.
That was like trying to fix a car by looking at the
engine and listening to it idle. Now, we have the tools
to take apart the engine and address the specific
problem. With a fast blood test, I can find out what is
driving my patient’s cancer so that we can find the
right treatment.
We can do this now because of decades of hard work
studying the molecular engines of many different
cancers, and it’s been a real blessing to my patients.
We don’t have to go through multiple rounds of
therapy and use a hit-or-miss approach with drugs
that have awful side effects. We have greater
assurance at the outset that we’re choosing a drug
that will work and that we are using a dose that is
likely to be effective and minimize side effects.
A New Model for Therapeutic Development
OLD MODEL: Treatment is determined by a tumor’s
location in the body, without regard to the molecular
charateristics of the patient or the tumor.
NEW MODEL: Treatment is determined by key
molecular “hubs” that must be targeted within the
cells, and is only administered to patients whose
tumors are found to have those hubs — potentially
without regard to the tumor’s location in the body.
Molecular
Pathways
Key Hub
Cancer Cell
ASCO’s Blueprint for Transforming Clinical and Translational Research 11
future ind ust ry Persp ecti ve
Therapeutic Development
ASCO envisions that in a decade, the following
experience will be routine:
With so much more known about cancer biology,
thanks to a lot of collaborative work with
other companies, NCI, and foundations, drug
companies are now able to make better tools for
doctors to use. It’s great to be working together
with other companies and these stakeholders in
the early stages of drug development, to build
knowledge we can all use in our research.
In the old days, it was like having only one tool
to do all your home repairs — if it worked for
removing the drywall it probably wouldn’t work
for the plumbing. Now, we are able to look at the
entire molecular system that drives a specific
cancer and design the tools to specifically fix
each part of the system.
And we’re not just developing drugs — we’ve
also been working with engineers and materials
scientists to come up with all kinds of new
devices to detect and attack cancers. This
cuts down on side effects and allows doctors
to individualize the treatment based on the
individual person and their cancer.
It’s much more rewarding to develop these more
comprehensive treatments than it was to work
on drugs that would just attack one piece of the
problem and increase life span by only weeks
or months.
disciplines will collaborate on the development of
innovative cancer treatment and prevention strategies,
and new strategies will incorporate a greater
variety of approaches. Already, for example, materials
scientists and chemical engineers are helping to
design new mechanisms to target cancer cells and
avoid normal cells.
yyClinical trials will routinely collect information directly
from participants to help determine how and
why investigational therapies affect patients differently.
This patient-reported data, including real-time
reports of symptoms and other patient experiences,
when combined with more complete information
about the genetic make-up of their cancers, will help
guide future research.
yyRegulatory agencies, trial sponsors and researchers
will begin discussions early in the therapeutic development
process, enabling faster review and approval
of new treatments and diagnostics. Together, regulators
and researchers will develop new processes and
decision-making tools to more effectively monitor,
collect and incorporate data on effectiveness and
potential side effects of different types and combinations
of new treatment and prevention strategies.
More Robust Biomarkers
Over the next decade, ASCO envisions that researchers
will identify and validate many new biomarkers
(see box, p. 8) that can be used to help prevent
cancers, detect cancers earlier, match patients with
effective treatment and prevention strategies at the
right doses, and monitor clinical benefit and predict
long-term outcomes. The availability of these new
biomarkers will also accelerate research by helping to
identify useful drug targets and patient populations
most likely to benefit, and to more effectively monitor
the impact of investigational treatments in trials:
yyNew devices will be able to rapidly analyze many
potential biomarkers at the same time, allowing researchers
to more quickly and easily identify those
that can guide research and patient care.
12 Accelerating Progress Against Cancer
yyBiomarkers and diagnostic assays will be developed
and validated simultaneously with new cancer treatments
— not as separate steps in the development
process as they often are today. This will shorten
the time before patients can benefit from new treatments,
by accelerating the availability of diagnostic
and monitoring tools that are required to guide the
use of new therapies in the clinic.
yyAdvances in imaging technologies will expand the
range of imaging options that can be used as biomarkers.
This will provide faster and less invasive
ways to detect and monitor cancers.
yyNew biomarkers will help to better define and
quickly identify the patient populations for specific
clinical trials, by allowing widespread, rapid screening
for specific genetic mutations and other molecular
features of the cancer.
yyNew biomarkers will enable expanded use of current
therapies to new tumor types that share key
molecular features. In a limited number of cases,
this is already occurring. For example, trastuzumab,
a treatment developed to target HER2 in breast
cancer, has shown promise for gastric cancer that
overexpresses the same protein.11
New Methods of Cancer Prevention, Diagnosis and
Treatment
Over the next decade, new technological advances will
open the door to entirely new methods of preventing,
diagnosing and treating cancer:
yyAdvances in materials science will allow researchers
to aim therapy directly at the physical tumor site, increasing
effectiveness and decreasing side effects.
For example, refinements in the use of microscopic
“nanoscale” technologies may better and more
safely deliver drugs to their precise target.
yyTools will be developed to identify “circulating tumor
cells” that have detached from a tumor and are traveling
in the bloodstream. These cells may be used to
detect cancer, measure the effectiveness of treatments
and monitor for cancer recurrence, without
more invasive techniques.
yyA greater understanding of biology, together with
new technologies, will allow researchers and clinicians
to identify and eradicate cancer stem cells — a
class of cells that gives rise to other forms of cancer
cells, and are thought to be the most critical to attack
in order to stop cancer’s spread and recurrence.
yyThanks to improved understanding of both the
genomics of cancer and tumor cells’ interaction with
the rest of the body, researchers will be able to develop
new immune therapies to harness the body’s
own ability to seek out and destroy cancer cells.
Reco mmendations
ASCO recommends that the following actions be implemented
over the next three years to accelerate therapeutic
development and make this vision a reality:
Establish clear priorities for therapeutic and prevention
strategies and biomarker development:
Identify and prioritize the targets that are most
urgently needed to advance cancer patient care,
and the biomarkers that will be essential to guide
the use and measure the effectiveness of resulting
therapies.
yyASCO will partner with other medical and scientific
professional societies and the National Cancer Institute
(NCI) — building on NCI’s existing “Provocative
Questions” project12 — to convene a series of workshops
with basic, translational and clinical researchers,
industry, the Food and Drug Administration (FDA),
patient organizations and other stakeholders to:
1. Identify and prioritize the most promising molecular
pathways to be targeted.
2. Identify new opportunities and approaches for
biomarker development.
3. Identify effective strategies to improve research
on new methods and combinations of cancer prevention
and treatment approaches.
ASCO’s Blueprint for Transforming Clinical and Translational Research 13
Incentivize collaboration in therapeutic development:
To support more efficient development and
evaluation of combined therapies and biomarkers
that will be central to the future of cancer care,
medical societies and cancer research advocates
should evaluate the need for financial and regulatory
incentives to ensure that industry and researchers
can pursue the most urgent priorities.
Mechanisms for “pre-competitive” collaboration
among companies, researchers, and government
and philanthropic research sponsors should also be
explored, particularly for the development of new
biomarkers. The process of biomarker discovery and
validation is complex, and requires networks of investigators
capable of open, intensive interactions, as
well as substantial funding support.
yyASCO will collaborate with partners at NCI and the
Institute of Medicine (IOM) to convene a working
group with industry, academia and other federal
agencies to:
1. Explore ways to promote a more collaborative approach
to developing new prevention and therapeutic
strategies. This discussion would seek
to develop a strategy that lowers the consequences
of failure to enable academic researchers and
companies to become more innovative.
2. Develop consensus on whether modifications are
needed to intellectual property law to facilitate
and incentivize collaboration.
3. Develop recommendations and a strategy to
create a clear pathway for regulatory review and
oversight of diagnostic tests that relate to use of
biomarkers and therapies.
yyASCO applauds National Institutes of Health (NIH)
and NCI efforts to encourage collaborative research
between academic and community research centers.
13, 14 ASCO encourages NIH and NCI to continue
to implement these types of changes. As part of the
grants review process, NIH and NCI should also provide
credit to research projects that involve a multidisciplinary,
collaborative approach.
14 Accelerating Progress Against Cancer
The Situation Today
Clinical cancer research — involving rigorous trials
that test the safety and efficacy of new therapies in
people — is the engine that drives progress against
cancer. Clinical trials are the only way to translate
cutting-edge laboratory discoveries into treatments
that extend and improve the lives of patients. Four
decades ago, the National Cancer Act led to major
new U.S. investments in clinical cancer research. Since
that time, clinical trials have yielded steady advances
in our ability to treat, detect and prevent cancer, and
have helped to significantly extend patient survival
and reduce mortality.
While progress has been substantial, it has generally
been the result of incremental advances over time.
Today, the remarkable pace of scientific and technical
change is opening the door to more rapid advances.
Yet our nation’s clinical research system is poorly
equipped to realize today’s scientific potential, and is
in desperate need of modernization and repair:
yyResearch sponsors currently devote substantial
resources to trials and therapies that promise only
marginal improvements over current standards
of care. In part, this is due to a lack of clear priorities
or a shared understanding of what constitutes
meaningful advances in patient outcomes.
yyIt can take up to five years to develop and initiate a
cancer clinical trial, and the time to complete trials
has increased steadily as a result of overlapping regulatory
requirements and complex data reporting.6
yyLow patient and physician participation rates lead to
delays in completion or even cancellation of trials. It
is estimated that less than 5 percent of adult cancer
patients participate in clinical trials, due to
factors including extensive “exclusionary criteria”
(factors used to limit participation in a trial, in order
to protect patients and ensure a statistically valid
trial result), low physician and patient awareness,
uncertainty about insurance coverage and other
barriers.
yyOpportunities to conduct faster trials are limited by
the small number of measures of efficacy that are
acceptable to regulators — measures such as overall
survival (the proportion of patients alive after a
given time period), progression-free survival (the period
during which a patient does not experience any
new tumor growth or cancer spread during or after
treatment) and disease-free survival (the length of
time a patient is in complete remission following
treatment). Researchers and regulators have been
slow to reach consensus on the meaningfulness of
other endpoints that could provide faster conclusions
about the value of new therapies, in part
due to insufficient ways to measure and document
patient improvement.
yyWe now understand that seemingly identical cancers
can be amazingly diverse at the molecular level, so
that only narrow subpopulations of patients may
respond to a particular treatment. However, most
clinical trials continue to use broad patient populations
that include many people who are unlikely to
respond to a targeted treatment because their cancer
does not have the relevant molecular defects.
This lowers the apparent effectiveness of investigational
treatments and exposes patients to unnecessary
side effects.
yyTrials do not routinely examine important indicators
II. Faster , Smarter Clinical Trials
ASCO’s Blueprint for Transforming Clinical and Translational Research 15
The Central Role of NCI’s Clinical Trials Cooperative Group Program
Most federally-funded studies of new cancer treatments
are conducted under the NCI-funded Clinical
Trials Cooperative Group Program. Through a network
of more than 3,100 institutions and 14,000 researchers,
the Cooperative Groups enroll more than 25,000
patients annually in cancer clinical trials and have
made enormous contributions to the nation’s progress
against cancer.15
Cooperative Group trials have brought breakthroughs
in adjuvant chemotherapy for breast and colon
cancers, breast-conserving lumpectomy to avoid
mastectomy (surgical removal of the breast) and new
standards of care for blood cancers, brain tumors and
many others.
Yet funding for the Cooperative Group Program has
declined in real terms in the past decade, threatening
this vital component of the nation’s clinical cancer
research system (see chart).
300
250
200
150
100
50
0
1999
Millions of Dollars (Adjusted for Inflation)
2004 2010
of patient benefit, such as quality of life, that could
help guide regulatory approval and future treatment
decisions.
yyStagnant federal funding of the NCI’s Clinical Trials
Cooperative Group Program in recent years (see
below chart) has stalled vitally important research
that industry has little incentive to conduct, including
studies that combine therapies from different
companies, test FDA-approved treatments against
different cancers, compare the effectiveness of
different treatments, address rare diseases
with little market potential or examine new
prevention strategies.6
yyThe United States is gradually losing its leadership
position in clinical cancer research, as important
trials move overseas in search of more trial participants,
less burdensome regulatory requirements
and lower-cost health systems.
ASCO’s Vision for the Next Decade
Over the next decade, ASCO envisions a clinical cancer
research system that is guided by clear priorities and is
flexible enough to pursue new scientific opportunities
as they emerge. With innovative trial designs and consensus
on research priorities, researchers will conduct
faster, more efficient trials that apply available resources
to the most urgent needs of people with cancer.
Major elements of this vision include the following:
yyResearchers, industry, patient organizations and
government agencies will reach broad consensus on
research priorities that hold the greatest potential
to improve patient care and address public health
need. Trials pursuing those areas will be prioritized
for funding by research sponsors.
yyAs cancer biology is better understood, the criteria
for participating in a trial will be based almost
Source: ASCO
Data from the National Cancer Institute; inflation adjustments based on
the National Institutes of Health Biomedical Research and Development
Price Index
16 Accelerating Progress Against Cancer
FUTURE RE SEARCHER PERSPECTIVE
Clinical Trials
ASCO envisions that in a decade, the following
experience will be routine:
Clinical trials are far more successful because
we have a much better idea of what to look for
and who to look for it in.
Our multi-talented teams can quickly take ideas
from the lab to the bedside because we have
biomarkers that allow us to measure a patient’s
response to therapy in a matter of weeks,
not years.
We can also take the data from the clinic back
to the lab and refine our trials or come up with
entirely new ideas. This smooth back-and-forth
allows us to zero in on what is driving the cancer.
That means we can select patients who will be
most likely respond, instead of testing a drug on
everyone and trying to figure out why it works
really well for only a few people.
And since we don’t need as many people for
any one trial, we can do more trials and develop
more treatments faster. It’s also easier to find
people to participate, now that we have tools
for patients to be more involved. Everyone who
is interested can receive alerts when a suitable
trial opens.
exclusively on the molecular characteristics of each
patient’s cancer. Trials will provide answers faster
and more conclusively, because they will include
only the participants most likely to respond to the
treatment being studied.
yyWhile researchers will need to screen larger numbers
of patients to identify participants for each
Smaller Trials, Bigger Chance for Success
OLD MODEL: Large numbers of patients, not
selected by molecular characteristics; lower chance of
demonstrating effectiveness, since many participants
do not have the molecular defects being targeted
NEW MODEL: Small patient populations, all with the
relevant mutations or genetic defects; greater chance
of desired results, since all participants have the
potential to respond
ASCO’s Blueprint for Transforming Clinical and Translational Research 17
trial, this task will be made easier through increased
international collaboration between scientific and
regulatory bodies. Such collaboration will enable
researchers to more readily recruit patients from
many different countries.
yyClinical trials will increasingly use adaptive designs
that allow researchers to adjust a given study’s
population during the course of the trial, based on
biomarkers that are found to be important as the
trial proceeds. By ensuring that study populations
consist of those patients who are likely to benefit, it
will be possible to shorten the time that is required
to complete trials and speed the development of
new treatment and prevention strategies. Increased
interaction between clinical, translational, basic
science and health services researchers will enable
ideas to flow more quickly from the lab to the
clinic and back. Given the growing complexity of
cancer science, a wider range of disciplines will be
involved in the development of clinical and translational
research concepts and protocols (e.g., materials
scientists, engineers and epidemiologists).
yyIn addition to survival and anti-cancer response, therapeutic
developers will routinely gather data on quality
of life when testing new therapies in clinical trials.
This will enable greater recognition of the value of a
treatment based not only on patients’ survival, but on
the quality of their survival. The FDA and therapeutic
developers will increasingly work together to enable
consideration of these factors in approval decisions
and to include this information on drug labels. This
will provide clinicians and patients with more information
about the benefits of approved treatments.
yyClinicalTrials.gov, the nation’s registry of federally
and privately supported clinical trials, will include
more critical information in a useful format, such as
information on initiated projects in early development
and trial results. This more robust database
will enable investigators to build on results of
completed research, prevent duplication and help
identify the most important research opportunities.
Reco mmendations
ASCO recommends the following actions be implemented
over the next three years to modernize the
way in which clinical trials are conducted and help to
achieve the vision above:
Prioritize trials with the greatest potential
benefits for patients: The cancer research community
should shift away from trials that promise
only marginal improvements in care, and prioritize
development of treatments, diagnostics and prevention
strategies that represent significant advances
for patients. Trials should focus on demonstrating
meaningful patient outcomes, including both significant
reductions in mortality and improvements in
quality of life.
yyASCO will partner with patient advocates to convene
a working group of experts in the field (including
industry, investigators from multiple areas of biomedical
research, NCI, FDA and insurers) to develop
consensus on the specific benefits that constitute
“meaningful patient outcomes.”
yyThe working group will develop proposals to encourage
broad adoption of meaningful patient outcomes
— for example, working with insurers to ensure these
outcomes are linked to eventual coverage of new
treatments, and encouraging peer-reviewed journals
and medical meetings to adopt policies that
prioritize publication and presentation of trials that
demonstrate such outcomes.
Select study populations based on molecular
characteristics: To the greatest extent possible,
clinical trials should be conducted in populations
based on their molecular characteristics. At the
same time, researchers should decrease use of
other, less meaningful exclusionary criteria, such
as having had prior cancers or having brain metastases.
In addition, clinical trial populations should
better reflect the racial, ethnic, age and gender
diversity of people with cancer.
yyASCO will partner with NCI, Cooperative Groups and
18 Accelerating Progress Against Cancer
industry to convene stakeholders in trial development
to examine current exclusionary criteria and
determine which criteria are scientifically required
and which can be eliminated as we move more
completely into the era of targeted treatment and
prevention strategies.
Employ flexible, efficient trial designs: ASCO will
bring together government agencies, academia and
public and private trial sponsors to develop shared
standards for new and flexible trial designs that
allow researchers to achieve results efficiently with
smaller, molecularly-defined sub-populations of
patients. These new trial design standards should
promote the use of surrogate study endpoints that
represent meaningful measures of benefit to patients
and will require less time to achieve.
yyBuilding on past work with FDA and professional societies,
ASCO will hold a state-of-the-science workshop
on surrogate endpoints to catalog successful
approaches, identify new standards and develop
strategies to improve their use and promote their
recognition by regulatory agencies.
yyASCO will create educational modules to enable
researchers and biostatisticians to make greater use
of innovative clinical trial designs.
Streamline data requirements for new uses of
existing treatments: In regulatory applications for
additional uses of already approved cancer drugs,
FDA and industry should streamline data reporting
by recognizing and building from the safety data
that already exists for the treatment. Collection of
new data should be focused only on those scientific
questions that are directly relevant to clinical decision
making. Such applications today require collecting
information on known, low-grade safety risks and
complete records of other medications being taken by
individual study participants. However, these data do
ASCO’s Blueprint for Transforming Clinical and Translational Research 19
not routinely inform regulatory or clinical practice decisions
and consume significant time and resources.16
Train health care providers in clinical research:
Medical societies and educational institutions
should encourage and train cancer care providers
to conduct clinical research as an integral component
of patient care.
yyASCO will develop and disseminate educational modules
and materials to teach core concepts of clinical
research. These will be designed for use during training
across all medical disciplines. The educational
content will address the conduct of clinical research
in both academic and community-based settings.
yyASCO will convene a working group with investigators
and leaders from academic and medical institutions
to discuss ways to recognize and reward
physician participation in research, with a particular
focus on team-oriented research.
Improve prioritization of NCI-sponsored trials:
ASCO supports the efforts of NCI and the research
community to prioritize NCI-sponsored clinical
trials.17 Policymakers and the research community
should work together to increase support for
high-priority, NCI-sponsored clinical trials while
streamlining regulatory and logistical processes to
expedite this vital research.6
yyASCO will partner with patient advocates, NCI,
federally funded research institutions and industry to
develop consensus on criteria for prioritizing cancer
trials. The discussion should address the concepts
of greatest public health need, meaningful patient
benefit and scientific opportunity.
yyNCI and private research sponsors should use these
consensus criteria when determining which research
to initiate.
Revitalize the NCI Cooperative Group program:
ASCO will continue its partnership with stakeholders
to ensure full implementation of recommendations
issued by the IOM in April 2010 (see box).
IOM Recommendations to Revitalize
the NCI Clinical Trials Cooperative
Group Program
In April 2010, the Institute of Medicine (IOM)
released its report, A National Cancer Clinical
Trials System for the 21st Century: Reinvigorating
the NCI Cooperative Group Program. The report
makes comprehensive recommendations to
modernize and strengthen this vital component
of the federally-funded clinical cancer research
system, which has contributed many of the most
important advances against cancer in recent
decades.
The major IOM recommendations are as follows:
• Improve the speed and efficiency of the design,
launch and conduct of Cooperative Group trials
• Incorporate innovative science and trial design
into cancer clinical trials
• Improve the prioritization, selection, support
and completion of trials
• Incentivize the participation of patients and
physicians
Additional, detailed recommendations are made
in each of these areas. (The full report is available
at http://www.iom.edu/Reports.aspx.)
ASCO supports full implementation of the
IOM report and is working with NCI, the IOM,
Cooperative Groups, patient advocates and other
stakeholders to advance key elements of the
recommendations.
For information about ASCO’s efforts, visit

http://www.asco.org/GroupReorganization.

20 Accelerating Progress Against Cancer
The Situation Today
Health information technology (HIT) has the potential
to transform clinical cancer research and improve
patient care. Yet this potential is only beginning to be
realized.
New HIT tools are urgently needed to help synthesize
the wealth of information that should inform patient
care and research: physicians need better tools to help
them stay abreast of rapidly evolving research and
make increasingly complicated treatment decisions;
patients need better tools to minimize the burden of
coordinating their own care and to easily provide their
doctors with information that could inform their care;
and researchers need better access to clinical data
and tissue samples to be able to identify research opportunities
and emerging trends in real time.
Today, we are only beginning to develop the capability
to process large amounts of data and use it to inform
cancer research and care. This is due to several
factors:
yyMany health care providers are just beginning to
use electronic health records (EHRs), which are
key to securely collecting, analyzing and sharing
patient information. In addition, standard formats
for recording patient information are lacking, making
it difficult or impossible to compare data from
different providers or health systems for research
purposes.
yyThere is no widely-used system that allows investigators
to access information from EHRs for research
purposes, while also protecting sensitive patient
information.
III. Harnessing Health Infor mation
through Technology
FUTURE PATIENT PERSPECTIVE
Health Information Technology
ASCO envisions that within a decade, the
following experience will be routine:
It used to be that all my doctors kept separate
records and I was the only one trying to track
everything. Now that all my health care providers
are using systems that communicate with each
other, they can see and update my information on
the same file. I can also review all my information
(diagnosis, treatment options and side effects to
expect) anytime I want on my smartphone. I can
record how I’m feeling so that my doctors know
what we should talk about before I arrive for my
next visit, and they can call me between visits if
there’s something I should take care of myself —
like taking fewer pills or picking up some medicine
from the drug store.
I also receive important information
electronically — last year I got an email when a
clinical trial opened up that I qualified for, based
on the information about my cancer in my EHR.
My cancer doctor got the same message, so we
talked about it at my next visit and I signed up.
I had to go for treatment at a different location,
and they pulled up my records and we were ready
to go; no hours wasted filling out the same forms
over and over again or retaking tests that I had
already done. The EHR even updated my primary
care doctor and my diabetes doctor.
ASCO’s Blueprint for Transforming Clinical and Translational Research 21
yyEHRs are not currently designed to alert patients
and physicians to newly approved prevention methods,
treatment options and clinical trials as they
become available.
yyData on patient biospecimens (tissue and blood
samples) is limited by the lack of standardized methods
for biospecimen collection, storage, analysis
and cataloguing. This limits researchers’ ability to
determine patient eligibility for clinical trials and to
identify new research ideas.
yyDebates about intellectual property rights and the
limited availability of secure systems to ensure
privacy of patient information limit the ability of
patients to contribute biospecimens and information
to inform clinical and translational research.
ASCO’s Vision for the Next Decade
ASCO envisions that within a decade, advances in HIT
will make it possible to dramatically improve patient
care and will allow researchers to draw upon the
wealth of real-world patient and physician information
to speed research. To help achieve this vision, ASCO is
leading the development of a Rapid Learning System
for Cancer Care, which will harness cutting-edge HIT
to connect cancer patients, their health care providers
and researchers to a central knowledge base; to
synthesize information from millions of physician and
patient experiences; and to deliver up-to-the-minute,
personalized information that allows every patient to
receive the highest quality care (see sidebar, p. 22).
Key elements of ASCO’s vision are as follows:
yyResearchers and clinicians will develop consensus
on baseline demographic and treatment information
to collect from all patients with cancer. HIT
developers will build these standardized data fields
into all EHR products. In addition, IT professionals
will develop secure systems in which investigators
can conduct health services and outcomes research
without compromising patient confidentiality.
yyPatient awareness of research will have increased
thanks in part to novel strategies like online recruiting
databases (see box, p. 23). Patients interested in
participating in trials will be able to securely enroll
in universal notification services that alert them
when trials relevant to their cancer’s molecular
characteristics become available. Investigators will
be able to use these notification services to send
information to appropriate patients and clinicians
when they launch a new trial.
yyAccess to real-time clinical data will greatly enhance
insight into how patients respond to therapies
and why. For example, it may help identify distinct
groups of patients who are more likely to respond to
a specific drug or are in need of other treatment options.
These insights will help drive clinical research.
yyAll patients will have the option to contribute to
clinical research by confidentially sharing information
from their EHR for research purposes. A secure
HIT environment will enable patients to permit
their clinical information to flow securely and freely
among oncologists, primary care providers and
researchers.
yyPatients and clinical trial participants will be able to
access a secure portal where they can enter information
about symptoms, side effects and health
status in real time. This information will not only
provide their oncologists with information needed
to quickly resolve the patient’s symptoms, but will
also provide more detailed, reliable information for
researchers about the real-world benefits and complications
of treatments.
yyData obtained from biospecimens will be electronically
linked in a secure environment to patients’
clinical information, allowing physicians to easily
explore relationships between the molecular characteristics
of a patient and their cancer — in order
to choose the best treatment, as well as identify the
most promising clinical trial opportunities. In addition,
researchers will be able to use information in a
22 Accelerating Progress Against Cancer
secure way to test hypotheses. This will also enable
a wide range of research from population-level effectiveness
modeling to quality improvement and
monitoring for the safe use of approved treatments.
Reco mmendations
In order to accelerate research and improve cancer
care through health information technology, ASCO
recommends the following actions be implemented
over the next three years:
Standardize oncology EHRs: ASCO will continue its
work with clinical, research and HIT stakeholders to
define the functional requirements and clinical and
research data elements needed for HIT products.
The elements should include:
yyAll relevant information in a consistent format,
including the cancer’s molecular characteristics, site
and prior treatments received by the patient.
yyInformation from ClinicalTrials.gov about available
clinical trials and eligibility standards. This will
ensure that physicians and patients are alerted to
clinical trials that may apply to the patient as they
become available.
Central
Knowledge
Base
PATIENT KNOWLEDGE
• Individual education
and decision support
• Real-time symptom
management
• Treatment plans
and summaries
• Treatment calendars
• Social support
PATIENT DATA
• Patient reported
information
PROVIDER DATA
• Electronic health record
• Practice management system
PROVIDER KNOWLEDGE
• Next-generation QOPI participation and
benchmarking reports
• Clinical guidance/decision support tools
• Meet quality reporting requirements
• Patient treatment plan and
treatment summary
• Patient identification for clinical research
• Information exchange with other providers
RESEARCHER KNOWLEDGE
• Comparative effectiveness research
• Health outcomes studies
• Population health studies
• Clinical trial development
• Evidence generation
RESEARCHER DATE
• New evidence
• Guidelines/guidance
ASCO’s Rapid Learning System for Cancer Care
This innovative, HIT-enabled rapid learning system
environment will help to improve the quality of cancer
patient care and accelerate research by forming a
continuous cycle of learning: capturing evidencebased
guidelines, evaluating quality of care against
those recommendations, and creating insights through
analysis of data from every patient experience.
To advance research, in particular, the system will:
• Provide a secure way to generate understanding of
the outcomes of cancer patients. This will provide the
research community with an unparalleled, high quality
dataset to speed research
• Empower patients by providing personalized
information, including clinical trials for which they are
eligible based on their cancer type
ASCO’s Blueprint for Transforming Clinical and Translational Research 23
yyThe ability to transfer data between clinical trial
databases and patients’ medical records to avoid
discrepancies.
yyStandardized fields for entering information about
biospecimens, to help facilitate treatment decisions,
determine patient eligibility for clinical trials, and
ensure that researchers can analyze and draw conclusions
from larger numbers of patients.
yySecure web-based and mobile applications that allow
patients to provide information about symptoms and
health status at any time.
yyTerminology standards for demographic information
and treatment outcomes that allow researchers
to more effectively conduct health services and
outcomes research.
Build ASCO’s Rapid Learning System for Cancer
Care: To make this groundbreaking system a reality,
ASCO is working with partners in the cancer,
research and informatics communities to:
yyTransform ASCO’s Quality Oncology Practice Initiative
(QOPI®) into a fully electronic system (http://
qopi.asco.org). QOPI is the first and only nationwide
system to help oncology practices monitor and improve
the quality of care they provide. Once the system
becomes fully electronic, practices will be able
to share data in real time, enhancing insight into
patient outcomes, improving quality and helping to
inform clinical research questions. The continually
expanding QOPI measures will be a core component
of ASCO’s Rapid Learning System for Cancer Care.
yyDevelop standards, applications and methods for collecting
patient-reported outcomes (i.e., symptoms,
side effects or quality of life indicators) in clinical
care and clinical trial settings and methods for notifying
patients and doctors of relevant clinical trials.
yyPartner with HIT developers to provide patients and
physicians with the most up to date information and
tools to guide decisions.
Using HIT to Increase Patient
Involvement in Research
Several innovative HIT-based registries are
helping to increase the number of people
available for participation in cancer clinical trials.
Examples include:
• Love/Avon Army of Women: An online registry
working to recruit one million women willing to
participate in breast cancer research. Women
with and without breast cancer share contact
information and basic demographic details, and
agree to be contacted when new studies open.
They are emailed when a new study becomes
available, and are asked to respond if they
are willing to participate. This approach has
dramatically accelerated patient recruitment
for some research studies — in one case,
recruiting as many women in 10 months as it
would have taken 3 years to recruit using a fulltime
recruiter (http://www.armyofwomen.org).
• ResearchMatch.org: An NIH-funded online
registry for healthy individuals willing to take
part in clinical research studies. Individuals fill
out an online form, including basic health data.
Researchers are able to search confidential
volunteer data through the ResearchMatch
website, and send a message to individuals who
are an appropriate fit for the trial. Volunteers
determine whether they are interested in
participating (https://www.researchmatch.org).
24 Accelerating Progress Against Cancer
Develop industry standards for working with
biospecimens: ASCO will work with NCI and with
colleagues in clinical research, pathology and epidemiology
to develop more comprehensive standards
and guidelines for biospecimen collection, storage
and analysis. This work will build on successful
molecular markers meetings and tutorials on biospecimens
that have been sponsored by ASCO, NCI
and the European Organization for Research and
Treatment of Cancer.
Ensure that advances in HIT protect patients and
researchers: ASCO will work with organizations in
the oncology community and appropriate regulatory
authorities (e.g., NCI, FDA and the HHS Office
for Human Research Protections and Office for
Civil Rights) to generate consensus on and support
standards for patient privacy, information sharing
and intellectual property protections to support HIT
innovation.
ASCO’s Blueprint for Transforming Clinical and Translational Research 25
This report presents ASCO’s vision for the future of translational and clinical research. ASCO’s recommendations,
when fully implemented, will help shorten the time between basic discoveries and development of new cancer therapies;
focus efforts on therapies with the highest probability of success; and significantly improve the patient experience
by enabling treatment to be better tailored to the needs of each individual.
We are not alone in our desire to revitalize clinical and translational research. Through our ongoing discussions with
colleagues at research institutions, professional and patient organizations, federal agencies and industry, it is clear
that others share many of the priorities laid out in this report — and all share our desire to accelerate the pace of
research and offer patients more meaningful prevention, detection and treatment options.
This report lays out ASCO’s initial recommendations and plans for implementation. We will build on these over the
next decade, using this vision as a guidepost to map and evaluate our progress. As an organization representing
cancer clinicians and researchers, ASCO plans to play a significant role in achieving the vision of this report. We are
already working on several fronts to make this happen, and we hope to collaborate with many other stakeholders in
the months and years ahead. Our major activities will include:
yyBuilding consensus to implement the recommendations. Over the next three years, ASCO plans to work with
other stakeholders to convene working groups with experts from the scientific and regulatory communities,
professional and patient advocate organizations and policymakers. The working groups will develop consensus
recommendations on the topics identified in this report, including ways to develop biomarkers and surrogate
endpoints, incentivize research collaboration, develop consensus on meaningful patient outcomes and research
priorities, and increased use of innovative trial designs. ASCO will vet the consensus recommendations, seek peerreviewed
publication and work with advocacy partners to develop strategies for implementation.
yyASCO programs and initiatives. ASCO is engaged in or planning a number of activities to help improve clinical
research. Several of these initiatives are noted in the Recommendations sections of this report. For example,
ASCO is working to build a rapid learning system to improve cancer care and speed research. ASCO is also
partnering with stakeholders to develop oncology-specific standards for HIT that are responsive to oncology
practice, include quality measurement and improvement and integrate research. In addition, ASCO has conducted
an analysis to determine how data sought in trials that study new uses for already-approved cancer treatments
can be streamlined.16 Future activities will include ongoing educational resources and support to help oncologists
adapt to new research approaches.
yyAdvocating for policy changes. In many ways, revitalization of clinical and translational cancer research will
depend on action by policymakers, including regulatory agencies. ASCO will continue working to raise awareness
and build support for needed policy changes through consensus development, research and modeling of the impact
of policy changes, new publications, events and other advocacy over the coming years.
CONCLUSION
The Way Forward
26 Accelerating Progress Against Cancer
Health Information Technology
Health information technology (HIT) describes the
management of health data that is shared securely —
among health care providers, patients, researchers
and insurers — through electronic health records and
other technologies. Recent advances in HIT promise
to help dramatically improve the quality of health care
and allow researchers to more quickly identify and
share promising treatment approaches.
Molecular Characterization
The process of analyzing cancer cells to evaluate the
genes, proteins and biological pathways that drive
cancer growth.
Nanotechnology
A field of technology utilizing materials on a scale
10,000 times smaller than a human cell to treat disease
or accomplish other tasks, e.g., nanoparticles.
Because of their very small size, these technologies
offer potential new ways to deliver treatments directly
to cancer cells.
Panomics
Panomics refers to the interaction of all biological
functions within a cell and with other body functions,
combining data collected by targeted tests (such
as a HER2 test) and global assays (such as genome
sequencing) with other patient-specific information.
By synthesizing this information, researchers gain a
deeper understanding of how multiple defects at the
molecular level combine with factors in the tumor’s
environment to drive tumor development and behavior.
This understanding is increasingly guiding drug
development and targeted cancer therapeutic and
prevention strategies.
Clinical Cancer Research
The branch of medical science that tests the safety
and effectiveness of promising new drugs, devices and
diagnostic products in humans. This research is often
conducted through clinical trials that involve human
participants and serve as the vital link between discoveries
in the lab and new treatments that improve the
lives of patients.
Biomarkers
Substances or biological features arising in tumor tissue,
blood or other bodily fluids that can be identified
through tests and used to diagnose or monitor cancer
and its response to treatment.
Cancer Stem Cells
A class of cells that gives rise to other forms of cancer
cells, and are thought to be the most critical to attack
in order to stop cancer’s spread and recurrence.
Cancerous Cells
Cells that are at any stage of becoming a cancer, from
pre-cancer states to advanced cancer.
Genomics
The study of how specific genes, and genetic mutations,
work together to influence the function of a
cell. In oncology, researchers focus on identifying and
targeting the genes, proteins and molecular pathways
that enable cancer cells to develop, replicate, spread
and resist certain therapies.
GLOSSARY
ASCO’s Blueprint for Transforming Clinical and Translational Research 27
Surrogate Endpoint
As defined by the FDA, “A surrogate endpoint is a
marker — a laboratory measurement, or physical sign —
that is used in clinical trials as an indirect or substitute
measurement that represents a clinically meaningful
outcome, such as survival or symptom improvement.
The use of a surrogate endpoint can considerably
shorten the time required prior to receiving FDA
approval” (see: http://www.fda.gov/ForConsumers/
ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/
default.htm). For example,
researchers may focus on tumor shrinkage or various
biomarkers that indicate a treatment is having an
effect. By identifying and validating surrogate endpoints
for use in future trials, researchers have the
potential to gain faster answers about the value of
new therapies.
Translational Cancer Research
Translational research transforms scientific discoveries
arising from laboratory, clinical or population
studies into clinical applications to reduce cancer
incidence, morbidity and mortality.
Pathway
A series of interconnected genes and proteins that
together control a certain function within a cell, such
as cell division or death. Mutations anywhere along a
pathway have the potential to disrupt normal cell function
and result in cancer cell development and proliferation.
Targeted drugs block specific cancer-related
pathways, with the goal of causing cancer cell death
while leaving healthy cells intact.
Patient-Reported Outcomes
Self-reported data from patients, most commonly
related to symptoms, quality of life and other general
health perceptions experienced during a medical
treatment.
QOPI
ASCO’s Quality Oncology Practice Initiative (QOPI®,
see: http://qopi.asco.org/) is a physician-led, practicebased
quality-improvement program used by oncology
practices in the U.S. It measures practices’ performance
against evidence-based guidelines, and against
other U.S. oncology practices, to give physicians
detailed feedback and tools for improving the care
they provide.
Rapid Learning System for Cancer Care
ASCO’s proposed Rapid Learning System for Cancer
Care will harness cutting-edge health information
technology to connect cancer patients and their
health care providers to a central knowledge base;
synthesize information from millions of physician and
patient experiences; and deliver up-to-the minute,
personalized information to inform care for every patient.
By collecting data in real time through electronic
health records and other technologies, the system will
also create a powerful new data source to generate
new ideas for clinical research.
28 Accelerating Progress Against Cancer
1. National Cancer Institute. National Cancer Act of 1971.

http://legislative.cancer.gov/history/phsa/1971

2. Kohler BA, et al. Annual report to the nation on the
status of cancer, 1975-2007, featuring tumors of the brain
and other nervous system. J Natl Cancer Inst. 2011 May
4;103(9):714-36.
3. Howlader N, et al. SEER Cancer Statistics Review,
1975-2008, National Cancer Institute. Bethesda, MD,
http://seer.cancer.gov/csr/1975_2008/, based on
November 2010 SEER data submission, posted to the
SEER web site, 2011
4. Stewart SL, et al. Cancer Mortality Surveillance—United
States, 1990-2000. MMWR Surveill Summ. 2004 Jun
4;53(3):1-108.
5. Ferlay J, et al. GLOBOCAN 2008 v1.2, Cancer Incidence
and Mortality Worldwide: IARC CancerBase No. 10
[Internet]. Lyon, France: International Agency for Research
on Cancer; 2010. Available from: http://globocan.iarc.fr
6. Institute of Medicine (IOM). 2010. A National Cancer
Clinical Trials System for the 21st Century: Reinvigorating
the NCI Cooperative Group Program. Washington, DC: The
National Academies Press.
7. Institute of Medicine. 2010. Transforming Clinical
Research in the United States: Challenges and
Opportunities: Workshop Summary. Washington, DC:
The National Academies Press.
8. Wolff AC, et al. American Society of Clinical
Oncology/College of American Pathologists guideline
recommendations for human epidermal growth factor
receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan
1;25(1):118-45.l
9. Bast BC Jr. Status of tumor markers in ovarian
cancer screening. J Clin Oncol. 2003 May 15;21(10 Suppl):
200s-205s
10. Weber WA. Positron emission tomography as an
imaging biomarker. J Clin Oncol. 2006 Jul 10;24(20):
3282-92
11. Bang YJ, et al. Trastuzumab in combination with
chemotherapy versus chemotherapy alone for treatment
of HER2-positive advanced gastric or gastro-oesophageal
junction cancer (ToGA): a phase 3, open-label, randomised
controlled trial. Lancet. 2010 Aug 28;376(9742):687-697.
12. National Cancer Institute. Provocative Questions Page.

http://provocativequestions.nci.nih.gov/

13. National Center for Research Resources. Clinical
Research Networks. http://www.ncrr.nih.gov/clinical_
research_resources/clinical_research_networks/index.asp
14. National Cancer Institute. Update on Implementation
of Recommendations of the Guidelines Harmonization
Working Group. http://deainfo.nci.nih.gov/advisory/
ctac/1210/presentations/GHWG.pdf
15. National Cancer Institute. National Cancer Institute’s
Clinical Trials Cooperative Group Program. Available at

http://www.cancer.gov/cancertopics/factsheet/NCI/clinicaltrials-

cooperative-group. Accessed October 19, 2011.
16. Kaiser LD, et al. Optimizing collection of adverse event
data in cancer clinical trials supporting supplemental
indications. J Clin Oncol. 2008 Dec 1;28(34):5046-53
17. National Cancer Institute. Transforming the
National Cancer Institute Clinical Trials Enterprise.

http://transformingtrials.cancer.gov/

REFERENCES
ASCO’s Blueprint for Transforming Clinical and Translational Research 29
American Society of Clinical Oncology
2318 Mill Road, Suite 800 • Alexandria, Virginia 22314
571-483-1300 • www.asco.org • www.cancer.net

Could Aspirin be a Viable Adjuvant Treatment for Cancer?

Comments Off
Posted 21 Oct 2011 — by James Street
Category aspirin, experimental treatments, Prevention, Vitamins and Supplements
 By Anna Azvolinsky, PhD | October 17, 2011

 

Epidemiological evidence as well as evidence from recent randomized trials suggest that aspirin may be of use in the adjuvant setting to treat cancer. Dr. Ruth E Langley and colleagues provide an overview of the evidence in favor of aspirin in cancer despite aspirin being “neither new nor expensive,” in a recent review in the British Journal of Cancer (British Journal of Cancer (2011) 105, 1107 – 1113).

Aspirin 3D model; source: Wikimedia Commons, user Rob Hooft

Despite being under the radar as a potential anti-neoplastic agent, the authors highlight continuing in vitro, pre-clinical, and in-human trials that are helping to uncover the mechanisms of aspirin in eliciting a tumor response. They highlight that aspirin affects multiple intracellular pathways and influences many physiological processes important in cancer progression such as apoptosis and angiogenesis.

Recent randomized trials that have aimed to show that aspirin can help to prevent cardiovascular disease have also shown a reduction in cancer incidence with long-term patient follow-up. Other traditional non-steroidal anti-inflammatory drugs (NSAIDs) have also been shown to play a role in cancer risk reduction.

Pre-clinical evidence and mechanisms of aspirin’s anti-cancer activity
The first evidence of a potential role for aspirin as an anti-cancer therapy was in a 1968 mouse   study, which showed that a platelet reduction was associated with a 50% reduction in metastases in mice. This result was supported by further mouse studies but the findings were never followed up on in human trials.

Aspirin inhibits the two isoforms of cyclooxygenase, Cox-1 and Cox-2, located in blood vessels, the stomach and the kidneys. Because cyclooxygenase is responsible for synthesis of prostaglandins, non-hormonal messenger molecules that regulate the inflammatory response, inhibition of Cox-1 and 2 facilitates in reducing inflammation. Prostaglandins also function in angiogenesis, apoptosis, cell proliferation and migration, and thrombosis.

While the authors point out that blocking prostaglandin synthesis is considered to be the main mechanism by which aspirin and other NSAIDS exert their anti-inflammatory function, it is not yet clear whether the anti-cancer properties of aspirin can be attributed only to its inhibition of the Cox molecules. Because aspirin binds to the Cox molecules irreversibly, despite having only a 15-20 minute half-life in the body, its effect on decreased platelets and a down-regulation of the high concentration of Cox-2 in tumors and the tumor stromal environment may be the explanation for its anti-cancer activity.

“Cox-2 over-expression is seen in a number of tumor types though it is not proven that the anti-cancer effects of aspirin are mediated through Cox-2” explains Dr. Langley.

Platelet inhibition may be important in metastasis.  It has been proposed that platelets affect the spread of metastases by allowing cancer cells to migrate more efficiently via an association with circulating white blood and endothelial cells and by protecting circulating cancer cells from natural killer cells.

Potential Cox-independent anti-cancer activities of aspirin include the inhibition of the transcription factor nuclear factor kb (NFkB) and an increase in apoptotic cells in neoplastic but not normal tissues. There is also in vitro evidence that aspirin can potentially interact with other tumorigenesis pathway molecules, including B-catenin and wnt signalling, tumour necrosis factor, as well as the DNA mismatch repair system.

The clinical evidence
According to the review authors, the first evidence that aspirin could act in chemoprevention was from a 1988 case-control colorectal cancer study that showed aspirin was associated with a significantly lower risk of the cancer after adjustment for other risk factors. Further large cohort trials showed that both duration of aspirin use and dose are important, with a maximum reduction of colorectal cancer seen with at least fourteen 325 mg tablets of aspirin per week for 6 to 10 years (Gastroenterology 134: 21–28 2008).

A few randomized, large-scale trials with a median follow up of 10 years have shown no reduction in risk of cancer with aspirin usage but, according to the authors, ineffective dose and scheduling, poor compliance, and longer-follows cannot be ruled out as reasons for the negative results. Two smaller randomized, 23-year median follow-up trials did show a reduced rate of colorectal cancer incidence in patients taking higher doses of aspirin (HR 0.73, P = .02) and a pooled analysis of these two trials also showed an overall reduced incidence of colorectal cancer (Lancet 369: 1603–1613). A meta-analysis of primary outcome measure trials, including seven randomized aspirin, with an average treatment period of at least 4 years showed a reduction in deaths from all cancers after 5 years of follow-up.

As far as evidence for a secondary prevention effect of aspirin, a meta-analysis of four trials in patients with colorectal or adenomas has suggested a reduced rate of reoccurrence of adenomas by 18% with daily aspirin usage. Additionally, two recent non-randomized therapeutic studies showed that those diagnosed with colorectal cancer who used aspirin regularly after their diagnosis had reduced colorectal cancer-specific and overall mortality. Additionally, those whose tumors over-expressed Cox-2 had the most benefit for colorectal-specific mortality. Similar results in 2010 were seen for breast cancer, with aspirin use after a breast cancer diagnosis being associated with a decreased distant diagnosis. Small-scale trials in lung cancer patients taking aspirin in combination with chemotherapy did not show any added benefit of aspirin and advanced renal cell cancer patients taking aspirin along with receiving interferon-alpha did not show any difference compared to interferon-alpha alone. “The most recent data from Peter Rothwell (Lancet Jan 2011) shows aspirin reduces mortality from most solid common tumors, not just colorectal cancer” says Dr. Langley.

Aspirin use is not currently recommended as a primary prevention strategy because of the risk of serious gastrointestinal bleeding, which goes up from 1% to 2-3% with regular use over 10 years. However, with more data, the benefit-to-risk ratio will likely be different for those with a low-burden early-stage cancer, the authors suggest. There is also the added benefit for those with cardiac disease.

They conclude that with the exception of the Thrombosis Prevention Trial and the Swedish Aspirin Low Dose Trial, the current epidemiological and randomized trial data support the idea that anti-cancer activity will more likely be seen with long-term high-dose aspirin use; that longer than 10-year follows are needed for future clinical trial; and that daily usage is more beneficial than alternative day dosage.

“Publicly funded researchers have a responsibility to ensure that drugs for which there is no longer a financial incentive for pharmaceutical companies to develop further are assessed in light of current knowledge and evolving clinical practice” the authors state in their discussion.

Perhaps this review will revive the interest in aspirin’s anti-neoplastic activity as the current epidemiological evidence suggests that aspirin is certainly worthy of further investigation “particularly in the adjuvant setting, when disease burden is expected to be minimal” according to Dr. Langley and colleagues. “Trials are clearly needed to assess daily aspirin as both a primary prevention agent in cancer and in the adjuvant setting,” stresses Dr. Langley.

Steve Jobs Regretted Wasting Time on Alternative Medicine

Comments Off
Posted 21 Oct 2011 — by James Street
Category Complementary and Alternative Medicine, experimental treatments, Nutrition and Cancer, Pancreatic

Steve Jobs Regretted Wasting Time on Alternative MedicineEveryone else wanted Steve Jobs to move quickly against his tumor. His friends wanted him to get an operation. His wife wanted him to get an operation. But the Apple CEO, so used to swimming against the tide of popular opinion, insisted on trying alternative therapies for nine crucial months. Before he died, Jobs resolved to let the world know he deeply regretted the critical decision, biographer Walter Isaacson has told 60 Minutes.

“We talked about this a lot,” Isaacson told 60 Minutes of Jobs’s decision to treat a neuroendocrine tumor in his pancreas with an alternative diet rather than medically recommended surgery. “He wanted to talk about it, how he regretted it….I think he felt he should have been operated on sooner… He said, ‘I didn’t want my body to be opened…I didn’t want to be violated in that way.’”

The account lends credence to a Harvard cancer researcher we quoted in a controversial post last week.

Ramzi Amri, a Fullbright scholar researching neuroendocrine tumors at the Harvard Medical School and at Massachusetts General Hospital, said the tumors of the subtype Jobs is believed to have contracted are “relatively mild” and very survivable if detected early. But Jobs delayed surgery for at least nine months, making it “sound to assume that Mr. Jobs’ choice for alternative medicine has eventually led to an unnecessarily early death.”

Says Isaacson:

He’s regretful about it… Soon everybody is telling him, ‘Don’t try and treat it with these roots and vegetables and these kinds of things…’ By the time they operate on him they notice it has spread to the tissues around the pancreas.

To understand Jobs’s prognosis, it is necessary to appreciate the precise type of cancer he had, and the subtype he is believed to have had. First, Jobs’s neuroendocrine tumor, also called an islet cell tumor, put him outside the 95 percent of pancreatic cancer victims who have highly fatal adenocarcinoma.

Second, Jobs is believed to have contracted one of the more survivable neuroendocrine tumors. It had several characters weighing the initial prognosis favorably, had Jobs acted as doctors recommended:

  • It was apparently functional, meaning it produced hormones, hence the “hormone imbalance” that Apple eventually acknowledged. These sorts of tumors are more “differentiated” from other cells and are thus considered less progressed and easier to treat.
  • Jobs’s tumor did not initially appear to have metastasized, as there were no outward signs of chemotherapy, though after being left untreated it did become metastatic and spread to his liver.
  • The tumor was in Jobs’s pancreas, among the more survivable locations a neuroendocrine tumor can appear.
  • Insulinoma, the type of tumor Jobs was most often reported and speculated to have had is also among the more survivable types.

The five-year survival rates on this chart give a good indication of the prognosis for insulinoma (88.7 percent) and tumors located in the pancreas (78.1). It also shows how much less survivable metastasic and non-function tumors—of the type Jobs is believed NOT to have had, at diagnosis—can be.

If you want more details, we’ve included some notes Amri sent us by email below. But suffice it to say, Jobs’s instinct for defiant iconoclasm and his insistence on unconventional approaches did not, in the end, serve him as well as it served Apple’s customers and shareholders. And it seems clear Jobs knew this, and wanted the rest of us to know it, too.


 


Additional Medical Details

Here’s how Amri explained things when we asked him on email about a particular type of neuroendocrine tumor with a lower survival rate (“non-functioning metastatic islet cell tumors,” whose survival rate is only around five years):

That number could very well be true, but there are two reasons it doesn’t apply to Jobs (and again, we’re on the border of speculation but it’s based on hard number and what Jobs said):

The metastatic part: Metastasis means the tumor spread outside its original site. His tumor probably wasn’t metastatic until when Jobs spoke of that “hormonal imbalance”, I believe in ’08 (source is easy to google). That was also the reason for his liver transplant: his liver was probably invaded by metastatic disease. If he had mets before, he certainly didn’t treat them as we’d have seen the obvious signs of chemotherapy appear.

The nonfunctional part, nonfunctional in those tumors means the cells degenerated to the point that they cannot carry out their original function, in this case, as I said in my first point, Jobs spoke about a “hormonal imbalance” when the disease recurred somewhere as late as ’08/’09. This means the tumor was -even then- clearly still producing hormones, proving it was a functional one, which is far less deadly than the nonfunctional ones.

This so-called called loss of differentiation is actually a strong predictor of how bad the tumor is in many cancers. The less differentiated it is, the more reckless it will be in its growth pattern and its tendency to spread.

For instance, in my colon cancer patients, they’re about 8 times as likely to develop or already have metastasis if their tumor is poorly differentiated as compared to well or even moderately differentiated tumor.

The subtype: so Jobs didn’t have a nonfunctioning one, but from what I read (please google to double-check) he even had an insulinoma, which is actually the most common and best treatable type.

He also had it in the pancreas, which is known to have one of the best prognosis averages.

Combine the two in this table comparing the different kinds of neuroendocrine tumors, add up the extraordinary level of care a man like Jobs can access and afford and you can see what I mean about his considerable chance of cure, hope it helps.

Amri also fielded questions (in italics) about this Slate piece:

1. “Islet-cell cancer, like Jobs and I had, is usually curable when
caught early” – this seems to fit with what you wrote. Is “curable”
the right word, i.e. it’s gone and you don’t die from it?

1 – Absolutely. If you’re on time, you can resect the tumor (depending on the site) without even needing to remove the pancreas or any other organ.

And since you’re early, the chances of it coming back as a recurrence from the original tumor are small.

There could always be an independent recurrence, if you have a familial disease that makes you at risk of developing these nasties (google MEN-1 for the most common example) but there’s no indication this was the case for Jobs and -one again- seen the level of care he can afford, I’m pretty sure that has been checked on him. It you do not have a familial disease, it’s like lightning striking twice at the same place. It happens, but with these tumors, that’s really, really unusual.

2. “After I was diagnosed, I was told that modern medicine doesn’t
have chemotherapy or radiation to use against islet cells. (“We’ve got
nothing that works” went the refrain.) ” I noticed in your piece you
mentioned Jobs seemed to eschew chemo; would he have had a choice?

2 – I think that was specific to his own case and his own subtype of islet-cell tumor.

In general, and especially if Jobs had a well-differentiated insulinoma, there are many treatment options, but when you’re early and the tumor is small enough, surgery is by far the best, in most cases you take the tumor out locally, check the local lymph nodes and if there is no spread in the nodes, you can confidently release the patient without any lasting side-effects, a low risk of recurrence and only a checkup consisting of a scan an labs every year or so as long as symptoms don’t come back.

- Chemo doesn’t always work and works in only about 10-20% of cases if the tumor is in the intestines or the stomach, but if it’s in the pancreas, some agents have been FDA approved and can help much more often.

Also, these numbers might appear worse than they really are because only the worst cases actually get chemo because most won’t need it at all. If you treat only the bottom, the average success will of course be low.

- There’s also radiotherapy with special isotopes that will be absorbed by the endocrine tumor cells that helps a lot if the tumor is metastatic.

- If that doesn’t help there’s the option of partial resection of the liver instead of removing the whole thing. The liver has the amazing faculty to partially regrow so a lot of the liver can be resected before the patient actually has a problem. This option is only available to those cases where the tumor is confined to either the right or left lobe, or in milder cases, only one of its eight so called Couinaud Segments.

All of that is usually tried before one refers to a liver transplant. If only because livers are very scarce organs and transplants to cancer patients are not always a good idea because of the immune-system suppressing drugs used to prevent rejection. They also partly suppress the body’s own immune reaction to any cancer growths, making the cancer more prone to spread.

Harvard Cancer Expert: Steve Jobs Probably Doomed Himself With Alternative Medicine

Steve Jobs had a mild form of cancer that is not usually fatal, but seems to have ushered along his own death by delaying conventional treatment in favor of alternative remedies, a Harvard Medical School researcher and faculty member says. Jobs’s intractability, so often his greatest asset, may have been his undoing.

“Let me cut to the chase: Mr. Jobs allegedly chose to undergo all sorts of alternative treatment options before opting for conventional medicine,” Ramzi Amri wrote in an extraordinarily detailed post to Quora, an online Q&A forum popular among Silicon Valley executives. “Given the circumstances, it seems sound to assume that Mr. Jobs’ choice for alternative medicine has eventually led to an unnecessarily early death.”

Amri went on to say that, even after entering conventional medical care, the Apple CEO seemed to eschew the most practical forms of treatment. Addressing the period when Jobs began to visibly shed weight, Amri wrote, “it seems that even during this recurrent phase, Mr. Jobs opted to dedicate his time to Apple as the disease progressed, instead of opting for chemotherapy or any other conventional treatment.”

When we contacted Amri at his Harvard Medical School email address to verify the post was his—he’s a researcher in the department of surgery at the medical school and research fellow at Massachusetts General Hospital—Amri emphasized, “I wrote that on a PERSONAL title and it’s my PERSONAL opinion.” On Quora, Amri expressed his “profoundest respect” for Jobs and that “I do not pretend to know anything about the case on a personal level and I never participated in the care of Mr. Jobs. I base all my cancer figures on my own research or sources from biomedical research known to me… I have done 1.5 years of research on the type of tumor that affected Steve Jobs and have some strong opinions on his case.”

According to a 2008 Fortune article, Jobs for nine months pursued “alternative methods to treat his pancreatic cancer, hoping to avoid [an] operation through a special diet.” The Buddhist vegetarian took this approach from the time he was diagnosed in October 2003 until at least the end of July 2004, when he underwent surgery at Stanford University Medical Center.

Harvard Cancer Expert: Steve Jobs Probably Doomed Himself With Alternative MedicineBy then the cancer was so far along Jobs had to lose his pancreas and duodenum in a “Whipple procedure.” The cancer also spread to all the major parts of his liver. “The only reason he’d have a transplant,” wrote Amri, “would be that the tumor invaded all major parts of the liver, which takes a considerable amount of time.” Amri said the Whipple procedure and liver transplant were clear signs the cancer was out of control and should have been stopped earlier.

The condition might have been nipped in the bud if Jobs had acted right away. Jobs’s cancer manifest in neuroendocrine tumors, which are typically far less lethal than the “pancreatic adenocarcinoma” that make up 95 percent of pancreatic cancer cases. Amrit said neuroendocrine tumors are so “mild” that…

“In my series of patients, for many subtypes, the survival rate was as high as 100% over a decade… As many as 10% of autopsied persons in the general population have been reported to have one of these without ever having had any symptoms during their life. Up to 30% of detected GEP-NETs are so well differentiated they’re strictly not cancers.”

But even “the most innocent cancer” needs to be removed quickly, which is why older men are always being lectured about colon cancer screenings; colon cancer tumors are thought to begin as removable polyps. In Jobs’s case, surgical removal may well have saved him if performed early enough, Amrit implies. He wrote:

“In many cases, a simple enucleation (just cutting out the tumor with a safe margin around it) is enough and leaves no residual side-effects.”

The cancer researcher made his comments about Jobs because he was looking for a lesson in his case. Doctors routinely face the ethical conundrum of being unable to treat patients because they’ve exercised their freedom to reject sound medical science.

But there is also, thankfully, a much clearer and easier lesson for patients in Jobs’s experience: Do not waste time. Don’t waste time by ignoring advice to get screened; don’t waste time by drowning yourself in research about your condition; and don’t waste time by delaying medically recommended treatment in the hops that something else will work.

Harvard Cancer Expert: Steve Jobs Probably Doomed Himself With Alternative Medicine“We saw the tumor slowly draining the life out him,” Amrit wrote of Jobs. “It was a horrible thing to see him lose weight and slowly turn into a skin and bones form of himself.”

That, in the end, may prove the most compelling reason to forgive the brilliant CEO his many faults: Of all the people who suffered on the dark side of his headstrong, iconoclastic decisionmaking, it was Jobs himself who appears to have paid the biggest price.

Steve Jobs dead at 56, his life ended prematurely by chemotherapy and radiotherapy for cancer

Note: This article expresses the opinion of Natural News Editor Mike Adams and not necessarily the opinion of this website.

Thursday, October 06, 2011
by Mike Adams, the Health Ranger
Editor of NaturalNews.com

(NaturalNews) It is extremely saddening to see the cost in human lives that modern society pays for its false belief in conventional medicine and the cancer industry in particular. Visionary Steve Jobs died today, just months after being treated for cancer with chemotherapy at the Stanford Cancer Center in Palo Alto, California. In recent months, he appeared in public photos as a frail shadow of his former self. The thin legs, sunken cheek bones and loss of body weight are all classic signs of total body toxicity observed in chemotherapy and radiotherapy patients.

Steve Jobs reportedly underwent both. His chemotherapy treatments at the Standard Cancer Center are now well known (http://www.marksmarketanalysis.com/…), and his secret radiotherapy treatments in Switzerland have now been made public by former Apple executive Jerry York.

Jerry York confided in Fortune Magazine about Steve Jobs’ secret flight to Switzerland to receive radiotherapy treatment for his cancer (http://tech.fortune.cnn.com/2011/01…). Fortune Magazine kept this secret until Jerry York died in March of 2010 (http://en.wikipedia.org/wiki/Jerry_…)), after which Fortune Magazine decided its confidentiality agreement with York no longer applied, and it published details about Jobs’ secret visits to Switzerland (http://gawker.com/5737092/steve-job…).

Fortune Magazine also repeats another fact about Steve Jobs that rarely appears in the press: Namely, that Steve Jobs underwent a secret liver transplant which raised eyebrows among many who wondered why a member of the wealthy business elite could receive a liver transplant essentially on demand while everybody else had to wait on a long transplant list (http://articles.cnn.com/2009-06-24/…).

In January of this year, Roc4Life.com reported:

“Jobs’ medical leave is due to cancer, but no one knows whether it stems from his 2004 battle with pancreatic cancer or complications from a secret liver transplant in 2009. According to recently deceased off-the-record source from Apple’s Jerry York, Jobs took an unpublicized flight to Switzerland in 2009 to undergo unusual treatment at the University of Basel. Switzerland’s University of Basel known for their radiotherapy treatments for neuroendocrine cancer and it’s unavailability in the U.S. Experts say Jobs’ pancreatic cancer has a history of reappearing and spreading to vital organs at a slow-growing pace, which probably explains the medical leave.”

In other words, there is no question that Steve Jobs underwent multiple conventional cancer treatments, including surgery, chemotherapy and radiotherapy.

In the end, however, even Steve Jobs could not overturn the laws of biochemistry. When you poison the human body, the result is the deterioration and eventual shut down of the body. Chemotherapy does not work! This fact should now be obvious, and yet every year, more and more people choose chemotherapy to their own demise — people like Farrah Fawcett, Peter Jennings, Patrick Swayze, Michael Douglas and many others (http://www.naturalnews.com/027047_c…).

Don’t they see that conventional cancer treatments do not work?

Losing Steve Jobs is a loss of a great visionary

It is striking that people who are geniuses in their own fields can understand so little about the fundamentals of human health. Steve Jobs was arguably one of the most influential visionaries of our time, and his development of human-technology interfaces revolutionized modern computing. Had he achieved another twenty years of life — and lived to 75 — he would have no doubt contributed to our world in even more profound and positive ways.

Yet his remaining life was stolen from him by the cancer industry and its poisons. This is yet another frustrating example of how the modern medical system harms our society. It steals from us the longevity of visionary individuals who have so much more to offer our world in terms of creativity and innovation.

Of course, you can’t blame the cancer industry for causing Jobs’ cancer in the first place. Some other cause had to have been present to get the cancer growing — probably a combination of nutritional deficiencies and exposure to environmental toxins. And yet the cancer establishment says nothing to people about correcting obvious nutritional deficiencies that lead to cancer, even when most cancers can be prevented for mere pennies a day.

The simple combination of vitamin D and selenium, if taken in combination, could probably prevent more than 80% of all cancers in America (http://www.naturalnews.com/021892.html). Yet the American Cancer Society and all the mainstream cancer non-profits don’t dare advocate vitamin D or selenium. If solutions were readily available to everyone, how would the cancer industry maintain its profitability?

The dark side of Apple

This gets us to the dark side of Apple, because just as the cancer industry is a greed-driven monstrosity that incessantly seeks profits at the expense of others, Apple has increasingly become a corporation that has routinely chosen for-profit domination over public service. This is not so much about Steve Jobs himself as it is about those who surrounded him and ultimately exploited his talents for their own selfish agendas.

Apple iPhones, for example, were recently exposed as secret tracking devices that record your location and upload that data back to Apple headquarters (http://www.naturalnews.com/032239_i…).

By any honest account, Apple operates today with a mindset of total monopolistic domination, requiring apps to be sold through its iTunes, where Apple takes an unfair cut of every sale. In fact, Apple has come to very much resemble the Orwellian Big Brother image that once made it famous in its January 22, 1984 Superbowl ad, which positioned Apple’s Macintosh computer as freeing people from tyranny. Watch that ad at: http://www.youtube.com/watch?v=HhsW…

What’s so striking about this commercial is that, in many ways, Apple has become the very thing it once claimed to oppose — domineering control, automaton conformity, and centralized command over the expression of musicians and programmers alike. The text of the ad says, “On January 24th, Apple Computer will introduce Macintosh. And you’ll see why 1984 won’t be like “1984.”

Thanks to companies like Apple, 2011 sure is a lot like 1984. A clever response to all this appears in a parody video that pits Steve Jobs in that “1984″ video as a way to show that Apple acts more like Big Brother with each passing day: http://www.youtube.com/watch?v=7zhH…

Anyone who has ever owned an iPhone knows all about being locked into a technology from which there is no free choice to do what you want with it. Why aren’t iPhones sold as “unlocked” from the get-go? Why do you have to hack your own phone just to free it from Apple’s domineering control? And why does your phone track your every move even without your permission or knowledge?

In fairness, this is almost certainly due to the greedy business types who surrounded Steve Jobs, and not Jobs himself. Jobs always seemed to be more of a humanitarian, but his concepts for innovation inevitably got swept up into the circus of profit.

Live by principle, because that’s the only thing you take with you

The more you look into the story of Steve Jobs and Apple, the deeper it all gets. And that brings us back to Steve Jobs and the topic of principles and ethics. All the wealth in the world couldn’t save Steve Jobs from cancer, of course.

Here’s a question for you: In his final days of life, would Steve Jobs have traded every bit of wealth he owned for a healthy new liver and pancreas? You bet he would! And yet he couldn’t. Because it doesn’t work that way. When it comes to organ health, there are no second chances. You’re given one set of organs to live with, and if you can’t figure out how to take care of those with nutrition, healthy foods and avoidance of environmental toxins, all the money in the world can’t save you.

Importantly, you don’t take money with you when you die, so collecting dollars or cars or even gold is little more than a short-term distraction set in the physical world. What you do take is a karmic record of your actions; a “universal log file” of your principles and ethics, if you will. And that’s what matters in whatever experience or reality awaits us beyond this one, whether you believe in Heaven, or reincarnation, or ascension to higher plane of existence.

Was Steve Jobs a positive influence on our world? Yes, I think so

I don’t pretend to be qualified to judge Steve Jobs on all his actions here on our planet, but the only honest question in helping to answer that is this: “Is our world better off because of Steve Jobs’ influence? Or is it worse off?”

On the whole, I believe Steve Jobs himself was a creative visionary whose talents eventually became co-opted by less-than-ethical corporate interests which operated outside his core intentions. This is precisely the reason why brilliant people should always be wary of “investors” or men wearing suits, because the whole purpose of venture capital is to grant people who don’t know how to really create wealth a way to sink their claws into those who do.

This is why I have consistently and successfully resisted all venture capital and buyout attempts targeting NaturalNews. To bring in big money people would destroy the heart and soul of what NaturalNews is all about, in the same way that all the big money people who eventually surrounded Steve Jobs ultimately compromised what was originally an uplifting vision for human freedom and expression.

(Even in the health industry, I can’t even tell you all the stories of brilliant, visionary people who have been betrayed by investors and corporate interests. It happens almost 100% of the time.)

The real lesson in Steve Jobs’ passing, then, is not “oh wow look at all these cool gadgets he left us” — because that’s the juvenile view — but rather “what can we learn from Steve Jobs about staying authentic in our own lives and our own decisions?”

What I’ve learned from Steve Jobs is that staying true to your vision is far more important than being commercially successful or collecting material wealth. Walking a path that gets your face on the cover of business magazines requires too much compromise of ethics and principles. The business community, after all, doesn’t usually celebrate real geniuses who share things with the world and make nothing from it. It only celebrates those who find clever ways to extract billions of dollars from the hands of consumers.

In fact, you might even say that the business world actually punishes those who bring real innovation to the world — people such as free energy inventors, most of which you have never heard about because they ended up mysteriously dead before they could bring their inventions to market. Steve Jobs was celebrated because his innovations were consistent with the culture of mass consumerism and unbridled corporate greed — buy more computing stuff, and buy it often! That makes investors rich, and that’s the name of the game in the business world.

Steve Jobs was celebrated, in other words, not for who he was on the inside, but for all the other people who got rich off him along the way. And that’s a shame, because even after his passing, I feel like we never knew the real Steve Jobs at all — the Steve Jobs who probably wanted to make the world a better place yet repeatedly found his talents being distorted and leveraged for bottom-line profits in a culture of greed that only cares about finding new ways to convince consumers to part with their money.

Steve Jobs may be dead, but the domineering greed of those who extorted his talent lives on. The iPhone 5 will probably be out in a year or so, so we can all throw away our old electronics which end up in a toxic landfill somewhere, and then replace it with new electronics made in a slave labor factory in China. Isn’t technology great?

Either way, may Steve Jobs rest in peace. May his name never be used for commercial exploitation again.

Targeting tumors with nanotechnology

Comments Off
Posted 03 Oct 2011 — by James Street
Category experimental treatments, Hypoxia, NanoTechnology, Personalized, Physics and Engineering

October 3, 2011

Mansoor Amiji, Distinguished Professor and Chair of the Department of Pharmaceutical Sciences at Northeastern University, has designed a nano-cocktail that targets multi-drug resistant tumors with remarkable accuracy and makes chemotherapy more efficient.

The findings, which were reported in the online-only scientific journal PLoS ONE, may lead to an increase in cancer patient survival by decreasing their exposure to large doses of chemotherapeutic agents.

The study, which dovetails with Northeastern’s focus on use-inspired research that solves global challenges in health, security and sustainability, was supported by a five-year, $2.32 million Cancer Nanotechnology Platform Partnership grant from the National Cancer Institute’s Alliance for Nanotechnology in Cancer program.

Lara Milane, a Ph.D. graduate in pharmaceutical science, and Zhenfeng Duan, an assistant professor of medicine with joint appointment at Massachusetts General Hospital and Harvard Medical School, also contributed to the report.

The Northeastern research team operated under the condition that tumor cells that grow in low-oxygen environments convert glucose into lactic acid, which makes cancer cells more drug resistant and harder to treat with chemotherapy.

They found that treating breast cancer cells with a glucose metabolism inhibitor, called lonidamine, made tumors more susceptible to the chemotherapeutic agent paclitaxel.

When coupled with lonidamine, only one-third of the typical dose of paclitaxel should be needed to kill as many cancer cells as a full dosage without the glucose metabolism inhibitor, Amiji said.

Administering smaller doses of anticancer drugs bodes well for patient health, he noted. “When you give patients more and more drugs, their bodies suffer from side effects and they may die from drug toxicity,” Amiji said. “The dilemma is to figure out a way to kill the drug-resistant tumor cells without exposing patients to too many drugs.”

In testing, lonidamine and paclitaxel were loaded into a tumor-targeted nanoparticle, which could not be seen without a high-resolution electron microscope, and then delivered through the bloodstream to the tumor’s exact location.

The smart-luggage system, as Amiji called it, is similar to that of a stamp-addressed envelope that could only be delivered to one particular mailbox. As he put it, “The nanoparticle only carries these two drugs to the tumor cells and does not expose the other parts of the body. At the tumor site, the drugs stay there longer so a patient won’t need as frequent dosing.”

The cocktail is at least five years away from being used in clinical practice, Amiji said. First, the drug’s safety and efficacy must be vetted in clinical trials, which are two or three years away.

“The FDA requires rigorous analysis of safety, especially when creating nanoparticles,” Amiji said.

View selected publications of Mansoor Amiji in IRis, Northeastern’s digital archive.

For more information, please contact Jason Kornwitz at 617-373-5729 or at j.kornwitz@neu.edu.

‘Trojan horse’ bacteria delivering tumor-killing blow comes from the soil

Comments Off
Posted 04 Sep 2011 — by James Street
Category Bacteria, Clinical Trials, Complementary and Alternative Medicine, Drugs, experimental treatments, Hypoxia

Posted Sun, 04 Sep 2011 23:01:00 GMT by

Cancerous tumors may just have met their nemesis, according to scientists speaking at the autumn conference of the Society for General Microbiology, which kicks off the UK tomorrow. But the fatal blow being delivered to dangerous tumors comes from an unlikely source – soil-dwelling bacteria, that have a special attraction for conditions found at a tumor’s heart. This new therapy - the result of collaboration between the UK-based University of Nottingham, and University of Maastricht, in Holland – should enter clinical trials within 2 years.

The bacterium being harnessed is widespread, harmless and has been on the planet for billions of years. Team leader, Professor Nigel Minton, described them: “Clostridia are an ancient group of bacteria that evolved on the planet before it had an oxygen-rich atmosphere and so they thrive in low oxygen conditions. When Clostridia spores are injected into a cancer patient, they will only grow in oxygen-depleted environments, i.e. the center of solid tumors.” This makes them ideal ‘trojan horse’ candidates for targeting tumors.

“This is a totally natural phenomenon, which requires no fundamental alterations and is exquisitely specific. We can exploit this specificity to kill tumor cells but leave healthy tissue unscathed,” said Professor Minton.  The trick to turning this selectivity into a tumor-killing therapy lies with giving the bacteria a weapon of attack. That comes from the insertion of an enzyme-producing gene into the Clostridia’s DNA. It is tuned-in to unlock a cancer-destroying ‘pro-drug’.

The pro-drug is separately administered, and remains harmless until the enzyme and pro-drug are combined. When this happens, the enzyme activates the drug, which takes on its destructive form – killing the cells around it. As only the cancerous cells have the Clostridia bacteria present, this is an elegant solution for removing tumors.

No need for the scalpel?

The approach is one that others have sought to make work, but the difficulty has been getting the bacteria to produce the right enzyme in the needed quantities. The team presenting their paper at this week’s conference feel that they have cracked this. Their bacterial strain has a gene that produces the enzyme more efficiently, and in larger amounts, than has previously been achieved.

The clinical trials are likely to be scheduled in the next 18 months. “We anticipate that the strain we have developed will be used in a clinical trial in 2013 led by Jan Theys and Philippe Lambin at the University of Maastricht in The Netherlands. A successful outcome could lead to its adoption as a front-line therapy for treating solid tumors.”

If all pans out as predicted, then we could see the therapy become a major new tool in defeating cancer. “This therapy will kill all types of tumor cell. The treatment is superior to a surgical procedure, especially for patients at high risk or with difficult tumor locations,” said Professor Minton. “If the approach is successfully combined with more traditional approaches this could increase our chance of winning the battle against cancerous tumors.”

How My Brain Tumor Woke Me Up To Life

Comments Off
Posted 28 Aug 2011 — by James Street
Category Complementary and Alternative Medicine, Educational, experimental treatments, Support Groups

Posted: 8/28/11 10:27 AM ET

Diagnosed with a brain tumor in 1998 when I was 24 years old, I knew nothing about cancer. Since then, my health and healing journey has taken me to places far and wide.

Within one month I had undergone awake brain surgery at the National Institutes of Health (NIH). I felt my left temporal lobe brain tumor — the center of speech, memory and sound — required awake brain surgery to help protect my cognitive functions. Twelve hours of surgery later — complete with awake speech and memory testing — neurosurgeons removed the brain tumor along with some surrounding tissue. In the ICU, my brain re-routed, my cells repaired, my bones mended, my jaw slowly unlocked, my heart trembled, my body acclimated to new terrain, my soul sung tunes and my spirit held me.

“You need to track brain tumor scientific studies for your tumor type and care for yourself,” said one of my neurosurgeons. I had no concept for any of it. Crisis serves as a powerful teacher and a catalyst for change.

Several opinions from pathologists diagnosed a lower grade stage of a brain tumor. For cancer patients, multiple opinions are necessary. No conventional cancer treatments were recommended. Instead, I had frequent MRI scans at Memorial Sloan Kettering Cancer Center (MSKCC).

Recovering from my surgery and learning about anti-cancer modalities, I built a team of providers and developed self-care strategies. I developed my health and healing map over many years. Some approaches and therapies supporting me involve acupuncture, herbs, holistic medical care, craniosacral treatments, exercise, dietary changes, homeopathy, Shamanic work, energy healing, dental work, psychotherapy and support groups.

Over time, my personal journey and professional cancer work begged the question, “What do people with cancer really need for improved quality of life and survival?” The answer for me has been integrative cancer care. Integrating more than the cancer diagnosis, integrative cancer care addresses the whole person of body, mind and spirit, including social and environmental health. I’ve found studies that show that integrative cancer care can possibly reduce cancer risk, and improve cancer survival and quality of life.

My integrative cancer care plan continues to evolve. In some ways, I began to feel stronger. Some aspects of my health and healing moved forward while other aspects moved backward. Dealing with fatigue and other ailments, I was finally told news about my tumor’s recurrence in February 2004. Not only was I informed about my brain tumor recurrence, I learned that the tumor actually regrew in 2000. Despite my frequent MRI scans, my doctor never informed me. It was a double whammy. Getting copies of medical records, questioning hospitals claiming to offer the best of cancer care, learning about advocacy and self-care — these were only some of the lessons I learned.

Moving toward thinking and creating anew, I added more integrative therapies and made more changes to my life. During the last five years, I completed four major cancer protocols, including three at cancer clinics in Europe and one in New York City. Once again, I became stronger in some ways, but other health problems surfaced simultaneously.

I’ve constantly tried to figure out where I have been and need to go. Now, more than 13 years after my brain tumor diagnosis, surgery, recurrence, more than 30 MRI scans, many cancer therapies, healing modalities, introspection, study and resources, my life contains new knowledge and personal transformation. I embrace adversity as opportunity, seeing healing as a never-ending road and life as a spiritual journey.

But change has occurred once again. A new chapter in my brain tumor journey began three weeks ago. My most recent MRI scan the end of July 2011 showed that my brain tumor requires me to have a second brain surgery. I’ve worked extremely hard trying to heal holistically and trying to avoid another surgery. Yet to stay alive, that is what I must do. On September 1, 2011, I’ll have awake brain surgery at the University of California San Francisco (UCSF) with Mitchel Berger, M.D.

While I live with uncertainty, vulnerability and sometimes pain, my knowledge and strength carries me forward. Eager and open to transforming my challenges into opportunities, I further evolve into my deeper self.

Through my own personal cancer experience and professional cancer work, I’ve identified some essential tips for cancer patients:

1. Self-Care: Make yourself a priority each moment, hour, day and week. Support your own whole person. Definitely sleep, relax, eat healthy, reduce stress, use mind-body support, lean on your spiritual and social connections, live in a clean and green environment and address any other needs you may have.

2. Support Team: Love yourself and receive support. Create a group of family members and friends to help you through your cancer journey. Specific types of support are wide and varied. You can even use Internet-based programs to organize help. Find what works for you. Be open.

3. Advocacy: Self-advocate, and receive help from loved ones and other professionals to navigate your cancer diagnosis, side effects, treatments and journey. Move step by step. Conduct research, ask quality questions, seek multiple opinions, maintain a willingness to change directions when necessary, and use other resources to improve quality of life and cancer survival.

4. Choose Quality Providers And Build A Team: Choose an oncologist with expertise in your specific cancer and access to excellent treatment facilities. I believe that quality cancer care must include other treatments for the cancer diagnosis and your whole person. Identify a group of integrative providers tending to many aspects of your health and healing. The full spectrum of comprehensive integrative cancer care will not come from one professional — instead it will occur through the help of a team.

5. Joy, Love, Passions And Purpose: Focus your attention on what you enjoy and the way that love brings light to your life. Express your passions and purpose in order to strengthen your innate healing capacity. I believe that passions flow through your heart. Purpose feeds from your core through embodiment of heart, soul and spirit.

With these essential tips, many other cancer resources, my personal cancer knowledge and professional cancer work, my commitment is to help people with cancer. You can learn more about integrative cancer care resources for the whole person through my non-profit organization called EmbodiWorks at www.embodiworks.org.