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Tumor Surgeon James C. Wittig, MD Featured in New York Magazine’s Best Doctors Issue for 2012

New York, NY (PRWEB) June 29, 2012

Dr. James C. Wittig has again been named a top orthopedic surgeon in New York magazine’s latest guide to the “Best Doctors in New York.” Time and again, Dr. James Wittig has earned the distinction of being among the finest in the country – and that’s according to leading physicians in his field.    Dr. Wittig, an Orthopedic Oncologist at Mount Sinai Medical Center, dedicates his practice exclusively to limb-sparing surgery; pediatric and adult bone and soft tissue sarcomas; benign musculoskeletal tumors; metastatic cancers; as well as complex hip and knee replacement surgery. In addition to his office at Mount Sinai Medical Center, Dr. Wittig sees patients at offices in Hackensack and Morristown, New Jersey as well as in Long Island, NY.

On any given day, you will find Dr. Wittig in surgery, making rounds or conferring with colleagues on the next best option for his patients. It is this assiduous schedule that keeps Dr. Wittig at the forefront of his field, earning him accolades yearly and again this year. In addition, he recently co-authored “Operative Techniques in Orthopaedic Surgical Oncology,” a much needed resource and whose time had come. Co-authored also by Martin Malawar, MD and Jacob Bickers, MD, the book was produced to provide a comprehensive guide on the surgical treatment for bone and soft tissue sarcoma and a heavy emphasis on limb sparing surgery.

He takes this accolade as another motivating force to continue to seek out and explore both new and technologically advanced medical treatments as well as share his experiences. The desire to help others coupled with his educational endeavors has grown tremendously from his roots as a child in Paterson to receiving his first honor in 1990, a Biology Department Honors Citation for Superior Academic Achievement followed by Summa Cum Laude status upon graduation from Seton Hall University. Four years later he received his Medical Degree from New York University School of Medicine where he was elected to the prestigious Alpha Omega Alpha (AOA) Honor Society and also served as president of the society. During medical school, he also received “Most Outstanding Research Presentation on Medical Student Assembly Day, The Lange Medical Publication Award for Outstanding Achievement as a Medical Student and the Glover C. Arnold surgical Award for the Medical Student who excelled in Surgery. From NYU he interned in General Surgery at St. Luke’s-Roosevelt Hospital Center and did his residency in Orthopaedic Surgery at Columbia Presbyterian Medical Center in New York City where he was appointed Administrative Chief Resident received the ‘Orren D. Baab Award for Excellence in Orthopedic Surgery, Member of the Senior Resident Staff who Best Exemplifies those Qualities of Academic Excellence, Clinical Proficiency and Capacity for Leadership, New York Orthopedic Hospital.’ Dr. Wittig continued to fine tune his surgical skills as a Fellow in Orthopedic Oncology at Washington Cancer Institute, Washington Hospital Center, Children’s National Medical Center, Armed Forces Institute of Pathology in Washington, DC as well as serve as a Sarcoma Consultant, Surgical Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.

The experience and accolades he has received along his medical journey has continued to enrich his desire to teach fellow colleagues as well as secure the best treatment options available for both adults and children affected by orthopedic tumors. While an Assistant Professor of Orthopedic Surgery at NYU Medical Center he received ‘Teacher of the Year for Outstanding Leadership, Guidance and Selfless Dedication to the Residents of NYU Hospital for Joint Diseases Department of Orthopedic Surgery Class of 2007.’     His desire was also transparent when he joined Mount Sinai Medical Center and was asked to develop a multidisciplinary team to treat sarcomas and other musculoskeletal tumors. In a two year span, he has performed over 600 cases and has dramatically changed the lives of those who have met him. Dr. Wittig has been instrumental in recruiting a team of specialists who focus on diagnosing and treating sarcomas as well as other types of bone and soft tissue tumors that affect the extremities, pelvis and spine. Currently, the team consists of specialized Pathologist Dr. Roberto Garcia; Musculoskeletal Radiologist Dr. Darren Fitzpatrick; Pediatric Oncologist Dr. Birte Wistinghausen and Radiation Oncologist Dr. Vishal Gupta as well as three Physician Assistants, 2 administrative assistants, a second orthopedic oncologist, Dr. Ilya Iofin and Dr. Sheeraz Qureshi, a spine surgeon focusing on a collaborative approach for spine tumors. The newest member to join Dr. Wittig’s team is renowned sarcoma cancer researcher and medical oncologist Dr. Robert Maki. Dr. Maki is also Chief of Pediatric Oncology and the Medical Director of the Sarcoma Program at Tisch Cancer Institute of Mount Sinai Medical Center. His vast array of experience, particularly his expertise in novel therapies for treating these complex sarcoma cancers, will ensure continuous research and development in this field.

James C. Wittig, MD specializes in limb-sparing surgery; pediatric and adult bone and soft tissue sarcomas; melanoma; benign musculoskeletal tumors; metastatic cancers; as well as complex hip and knee replacement surgery. He also has special expertise with regard to tumors that affect the shoulder girdle and scapula. In addition to his office at Mount Sinai Medical Center located at 5 East 98th Street, New York, NY, Dr. Wittig has satellite offices affiliated with Hackensack University Medical Center, at Continental Plaza, 433 Hackensack Avenue, 2nd Floor, Hackensack, NJ and Morristown Memorial Hospital, at NJ Advanced Musculoskeletal Center, PA, 131 Madison Avenue, Suite 130, Morristown, NJ and ProHealth in Long Island. Currently, Dr. Wittig is Associate Professor of Orthopedic Surgery, Chief of Pediatric and Adult Orthopedic Oncology and the Sarcoma Program at Mount Sinai Medical Center in New York City as well as Chief, Orthopedic Oncology and Director, Sarcoma Section of the Cancer Center, Hackensack University Medical Center. He is a member of the American Academy of Orthopedic Surgeons; New York State Society of Orthopedic Surgeons, Inc.; and the Medical Society of New Jersey. He has published over 90 educational materials ranging from original reports, abstracts, videos and articles in the following publications: Clinical Orthopedics and Related Research, The Journal of the American College of Surgeons, American Family Physician, Journal of Arthroplasty, Radiology and Journal of Bone and Joint Surgery. He is also a prominent lecturer in the field of Orthopedic Surgery throughout the nation.

For more information about this or other related topics, or to schedule an appointment, please call (212) 241-1807, visit http://www.TumorSurgery.org or email Dr. Wittig at drjameswittig(at)gmail(dot)com.

Read the full story at http://www.prweb.com/releases/2012/6/prweb9650840.htm

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Failure Rate Varies With Expandable Femur Prostheses

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Posted 12 Feb 2012 — by James Street
Category Artificial Knees and implants, Osteosarcoma surgery

Laird Harrison

February 10, 2012 (San Francisco, California) — Three types of expandable femur prosthesis were similarly effective in patients with osteosarcoma, but the mechanical failure rate of the 3 devices varied, researchers reported here at the American Academy of Orthopaedic Surgeons (AAOS) 2012 Annual Meeting.

The 3 devices examined were the How-Medica Modular Resection System (Stryker Orthopaedics; Mahway, New Jersey), the Repiphysis (Wright; Arlington, Tennessee), and a device by Stanmore (Middlesex, United Kingdom).

“There were no significant differences between the 3 types of prostheses where the mean score or functional MSTS [American Musculoskeletal Tumor Society] was observed,” said Pietro Ruggieri, MD, PhD, chair of orthopaedic oncology at the Instituto Ortopedico Rizzoli in Bologna, Italy.

However, the 3 were not all alike in terms of function. The lengthening mechanisms in the Repiphysis and the Stanmore prostheses work by electromagnetism, so surgery is not necessary.

In the Stanmore prosthesis, surgeons periodically use a hexagonal key inserted through a 1 to 2 cm stab incision to telescopically extend the implant.

“The Stryker prosthesis, although it requires open lengthening procedures, has shown significantly fewer complications, compared with the Rephysis,” Dr. Ruggieri reported.

Overall, the researchers implanted 39 devices in 32 children with a mean age of 9 years at initial surgery.

Mean total lengthening of 26 mm was achieved with 78 procedures (2.4 procedures per patient).

The Stryker

The surgeons implanted 17 Stryker devices. They achieved a mean total lengthening of 5 cm, with a mean of 4 lengthenings. Mean lengthening per procedure was 1.5 cm.

The mean MSTS score was 24. There was 1 mechanical failure. Six patients achieved skeletal maturity.

The Wright

The surgeons implanted 15 Wright devices. They achieved a total lengthening of 3.6 cm with 3 lengthenings. Mean lengthening per procedure was 1 cm. One patient achieved skeletal maturity.

The meant MSTS score was 23.4. There were 5 mechanical failures, with an additional 2 failures after the researchers submitted their abstract. One patient achieved skeletal maturity.

The Stanmore

The Italian team implanted 7 Stanmore devices. They achieved a mean lengthening of 10 mm, with 4 mm per lengthening, but the follow-up time was shorter for this device, so it could not be directly compared with the other 2.

The mean MSTS score was 27.4. There were no mechanical failures, and no patients achieved skeletal maturity.

The Outcomes

Although all 3 devices achieved satisfactory lengthening, “the Repiphysis prosthesis had a dramatically, tremendously higher, radically higher incidence of mechanical failure,” said Dr. Ruggieri.

The difference in the survival rate of the Wright and Stryker devices was statistically significant (P = .026).

The differences in MSTS scores were not statistically significant between the groups (P = .934).

The follow-up time for the Repiphysis and Wright devices was 72 months. Dr. Ruggieri, who has submitted his results for publication, declined to disclose the follow-up time for the Stanmore device.

The findings came as no surprise to session moderator Bryan Scott Moon, MD, assistant professor of orthopedic oncology at the University of Texas M.D. Anderson Cancer Center in Houston.

“He kind of reaffirmed what we all knew — that there is a fairly high failure rate with these,” Dr. Moon told Medscape Medical News. He was not involved in the study.

The Stanmore results were tantalizing, Dr. Moon said. “Stanmore had a lower failure rate, but they have not done enough to know for sure. We are hoping eventually more data come out.”

Dr. Ruggieri and Dr. Moon have disclosed no relevant financial relationships.

American Academy of Orthopaedic Surgeons (AAOS) 2012 Annual Meeting: Abstract 167. Presented February 8, 2012.

The Power of Preservation: Minimally Invasive Lung Cancer Treatment at South Nassau Communities Hospital

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Posted 03 Jan 2012 — by James Street
Category Lung Cancer, Osteosarcoma surgery, Surgery, Surgery, Thoracic Surgery

A decade ago, a lung cancer diagnosis left both patients and physicians with few options. Today, while surgery remains the gold standard, the approach to this treatment has changed. Thoracic surgeons at South Nassau Communities Hospital are forging innovative surgical ground and safeguarding patients’ lungs.

According to the American Cancer Society, 221,130 new cases of lung cancer will be diagnosed in 2011. Almost 17,000 cases of esophageal cancer will be diagnosed, and, though the incidence rate is extremely low, patients with these types of cancers can develop tumors within and around the heart. Before 2004, Long Island residents with disease of the chest cavity made the long trek to Manhattan for consultations, treatments and follow-up care.

With the arrival of Shahriyour Andaz, M.D., FACS, FRCS, Director of Thoracic Oncology at South Nassau Communities Hospital and associate professor in the Department of Surgery at Hofstra University, two principles of thoracic care on Long Island have shifted significantly. Patients now have an alternative to Manhattan medicine, and with the investment in advanced technologies at South Nassau Communities Hospital, they also have an alternative to traditional open chest surgery.

“In the past, surgeons would make a large incision to cut the ribs and access the chest. That was a painful operation, so we’ve moved away from major incisions to doing smaller and smaller cuts,” says Dr. Andaz. “Now, 80% to 90% of all the cancer we take out is done through small, minimally invasive incisions.”

A Renaissance of Surgical Technique

The robotic da Vinci Surgical System offers Dr. Andaz and his colleagues in the thoracic oncology program the visualization and maneuverability necessary to promote minimally invasive approaches to technically demanding procedures. The three-dimensional views and flexibility of robotic hands, which are carefully controlled by the surgeon, facilitate the delicate dissection of blood vessels and the resection of the lungs’ lobes through centimeter-long incisions.

In the case of a video-assisted thoracoscopy, which allows the surgeon to evaluate the chest cavity for lung cancer or remove a tissue sample for further analysis, the da Vinci Surgical System has supplanted the need for an open chest thoracotomy. Dr. Andaz makes two or three small incisions between the ribs, and the lung is deflated to allow for a greater space between the lung and chest wall. That vantage point provides access to the lung for an endoscope, which Dr. Andaz uses to view and sample any potentially malignant tumor on the lung. The sample is then sent to the laboratory for pathological testing.

While the da Vinci Surgical System is utilized for general, gynecologic, kidney, prostate and urologic procedures, the technology allowed Dr. Andaz to become the first health care provider on Long Island to perform a robotic thymectomy and robotic bilobectomy in 2010 and 2011, respectively.

Operating Across the Aisle

“Most surgeons will not do a bilobectomy for central tumors — the type of tumor that straddles the airway and involves blood vessels stuck to the tumor,” says Dr. Andaz. “The da Vinci can help with the tedious process of dissecting those blood vessels.”

The complexity of a bilobectomy is grounded in the need to remove both the lower and middle lobes of the lung — leaving only the upper lobe — to ensure that wide enough margins are created and no cancer cells are left behind. In addition, the complex network of blood vessels stretching over the fissures in the lungs poses a challenge in cleanly resecting the necessary portions of the lung.

To begin, the attending anesthesiologist puts the patient under and slowly deflates one lung. Dr. Andaz then makes four 2-centimeter-long incisions in the chest wall and guides the da Vinci Surgical System’s robotic arms into the chest through the incisions, allowing him to concentrate on excising the lower lobe. The precise instrumentation divides the blood vessels and pulmonary vein from the lung tissue without disrupting the blood flow to the heart.

Next, Dr. Andaz exposes the fissure between the lower and middle lobes to allow for visualization of the pulmonary artery. With the three-dimensional da Vinci Surgical System camera, he is able to safely encircle and divide the branches leading to the lower lobe. After removing the lower lobe tissue, 
Dr. Andaz begins dissecting the pulmonary artery branches to the middle lobe. That separation allows him to dissect and divide the bronchus to the middle and lower lobes.

Dr. Andaz explains that the ability to remove both the lower and middle lobes of the lung can often depend on how much reserve a patient has in his or her lungs. The resection of one lobe diminishes lung function by 10% to 15%; the loss of two lobes results in a 20% to 25% reduction in total capacity; and the removal of all three lobes — the entire right lung — equals a 40% to 50% loss of the combined lung capacity. All surgical candidates undergo pulmonary function testing before being cleared for robotic surgery.

After the final tissue resection, Dr. Andaz retracts the da Vinci Surgical System’s arms and closes the incisions while the anesthesiologist carefully re-inflates the lung. Patients typically remain in the inpatient unit at South Nassau Communities Hospital for four to five days.

Tackling the Thymus Gland

Just as the da Vinci Surgical System has allowed Dr. Andaz and his colleagues to move away from the open chest thoracotomy, the technology has opened up new avenues for removing the thymus gland. The traditional procedure involved splitting the sternum with a major incision to access the chest cavity. Dr. Andaz can perform a robotic thymectomy instead, which approaches the organ — located in a tight space between the heart and the breastbone — through small incisions placed on the side of the patient.

“Usually, as a person ages, the thymus gland — like the tonsils — becomes smaller and almost disappears,” says Dr. Andaz. “For some people, however, the thymus gland continues to grow and enlarge and can lead to myasthenia gravis, an autoimmune disease that allows small proteins to cling to muscle receptors and leads to a neuromuscular disorder.”

Myasthenia gravis can present through symptoms centering on fatigue, including drooping eyes, difficulty breathing, chewing and swallowing, and weakness in the arms and legs. As Dr. Andaz explains, removing the thymus gland in patients with the condition can provide significant relief for their symptoms.

For the robotic procedure, 
Dr. Andaz makes three 2-centimeter incisions at the side of the chest for lateral access. Seated at the da Vinci Surgical System console, Dr. Andaz manipulates the robotic arms to find the thymus gland behind the breastbone. He then completes the delicate separation of the gland from the adjacent fat, pericardium and the innominate vein.

After resecting the thymus gland, Dr. Andaz closes the incisions, and the anesthesiologist re-inflates the lung. Patients typically spend one to two days in the hospital and are back to work in one or two weeks.

Targeting the Right Site

For lung cancer patients whose poor lung reserves eliminate them from the surgical candidate pool, radiation has traditionally been the next treatment option. The choice is often made in an attempt to conserve what little function the lungs have. However, standard radiation often poses a significant threat not only to the tumor, but also to the surrounding healthy tissue.

“The problem with standard radiation is that the treatment can essentially cook the entire lung. The radiation can damage the surrounding lung tissue, which is difficult for someone who has poor lung reserve to begin with,” says Dr. Andaz. “The Novalis Tx radiosurgery technology uses advanced computerized techniques to focus an intense radiation beam on the tumor site only to preserve the rest of the lung.”

The radiosurgery platform offers a noninvasive, customizable treatment alternative to surgery. The system’s mechanical accuracy is within 0.5 millimeters of the tumor site during treatment, while the MV Portal Vision allows radiation oncologists to view the exact location of the tumor as the system targets it.

The Novalis Tx is also equipped with gating features to adapt the radiation to the patient’s natural respiration cycle. In addition, the system reduces the requisite number of treatments as compared to the standard radiation therapy. Patients undergo treatment once a week for only three to four weeks rather than six weeks.

The Communal Process

Every month, the specialists within the thoracic oncology program meet for a program-specific tumor board. The conference reviews patient cases one by one for insight from each physician, even those not directly involved in the treatment, which allows for a dynamic and multifaceted discourse. Medical oncologists, pathologists, pulmonologists, radiation oncologists, radiologists and surgeons are joined by primary care physicians to evaluate a patient from every possible perspective.

“These are very complicated decisions, and it requires lots of people to be involved in the decision-making process,” says Dr. Andaz. “I’m very open to the discussion of alternatives to the management of the case.”

In addition, staff with the thoracic oncology program participate in the weekly tumor board at South Nassau Communities Hospital and meet on a need-appropriate basis between the established conferences.

To learn more about thoracic oncology at South Nassau Communities Hospital, visit www.southnassau.org and click on “Surgical Services” and “da Vinci Robotic Surgery” under the “Services/Specialty Centers” tab.

 

A Measure of Change in Lung Cancer Detection

To maximize the rate of survival among women with breast cancer, the American Cancer Society recommends every woman receive a mammogram annually after age 40. To increase the survival rate among men and women diagnosed with colon cancer, the organization advises people older than 50 undergo a colonoscopy every 10 years. Now, lung cancer has a similar screening recommendation.

A 1991 initiative launched by a group of physicians from Cornell University Medical Center — investigating the impact of helical computed tomography (CT) imaging on the early detection of lung cancer — discovered that, when caught in Stage I, lung cancer isn’t as deadly.

“The traditional data has shown the overall survival rate is 15% at five years, meaning that 85% of patients will die,” says Shahriyour Andaz, M.D., FACS, FRCS, Director of Thoracic Oncology at South Nassau Communities Hospital and associate professor in the Department of Surgery at Hofstra University. “The participants in the Cornell study showed a survival rate far superior than any other data we have: 90% at 10 years. Even though lung cancer is three times as prevalent as breast cancer, there has been no test to detect early lung cancer — until this.”

In fact, the initiative has developed protocols to a) identify high-risk patients, b) distinguish between benign and malignant nodules detected by the CT scan, and c) determine when to biopsy or monitor the nodules, as well as timetables for when to follow up with patients. The International Early Lung Cancer Action Program (I-ELCAP) includes 48 institutions in nine countries, including South Nassau Communities Hospital, where Dr. Andaz pioneered the program.

Dr. Andaz recognized the significance of the I-ELCAP, and for the last three years, South Nassau Communities Hospital has contributed data to the program while offering free CT scans for high-risk patients in the community. The data is then sent to Mount Sinai Medical Center and incorporated into the I-ELCAP database. According to Dr. Andaz, of the 800 to 900 patients imaged at South Nassau Communities Hospital, 30 have been diagnosed with lung cancer, and 90% of the cases were detected within Stage I.

 

Infected Total Femoral Replacements: Evaluation of Limb Loss Risk Factors

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Posted 04 Nov 2011 — by James Street
Category Artificial Knees and implants, Osteosarcoma surgery

Correspondence should be addressed to: Kathleen S. Beebe, MD, Department of Orthopaedic Surgery, University of Medicine and Dentistry of New Jersey, Newark, NJ 07103 (beebeka@umdnj.edu).

Posted Online: November 09, 2011

With continuing advances in medical technology, limb salvaging has become a more common method of treatment in the orthopedic field. One method that has significantly benefited from recent advances is the use of implants after a large resection of bone that is typically caused by large bone neoplasms. Because the femur is one of the most common sites of primary bone sarcomas, 1-4 treatment of large femoral tumors was previously limited to hip disarticulation or hemipelvectomy. 5 Advancements in endoprosthetic implants, chemotherapy, radiation, and diagnostic imaging have allowed for massive bone resection of the femur caused by primary bone tumors to be treated with total femoral replacements (TFRs). 1,6-8 Total femoral replacement has not been limited to massive oncologic resections but has also found an application in nononcologic indications, such as failed total hip arthroplasty, osteomyelitis, and failed internal fixation. 5,9 Although no evidence of improvement in either quality of life or survival following limb salvage procedures exists, some studies have shown improvements in cost-effectiveness and overall function of the salvaged limbs. 7,8,10,11

Although TFR is an orthopedic advancement, this method has complications. One of the most unfavorable complications of TFR is failure due to acute or chronic periprosthetic infection. 6,7,12,13 However, to the authors’ knowledge, no studies that analyzed the possible risk factors for unsalvageable TFRs in individuals with periprosthetic infection have been published.

Materials and Methods

Approval for a retrospective chart review was obtained from the institutional review board, and data were collected from the New Jersey Medical School Orthopaedic Department surgical database from the years 2000 to 2010; 10 patients met the inclusion criteria of the study. The inclusion criteria of the study consisted of individuals with TFRs who subsequently were identified as having periprosthetic infections. Periprosthetic infection was defined as (1) the presence of a growth of microorganisms from a pre- or intraoperative joint aspiration; (2) purulence surrounding the prosthesis at the time of surgery; or (3) acute inflammation consistent with infection on histopathological examination. 14

Early infection was defined as periprosthetic infection occurring within 3 months of TFR surgery, whereas late infection was defined as an infection occurring 3 months after surgery. Recent history of infection was defined as an infection that was present within 6 months prior to the TFRs. Patients received either primary or secondary TFRs. Primary TFRs were defined as those performed in individuals who received a TFR as the primary method of treatment for the disease. Secondary TFRs were defined as TFRs that were implanted due to primary implant failure and further surgical or medical intervention to retain the patient’s primary implant was considered ineffective. The standard surgical technique for primary or revisional TFR was used on all patients.

The information collected from the 10 identified patients included age, primary diagnosis, hospital course, surgical management, and follow-up. These cases were divided into 2 groups: unsalvageable TFRs and salvageable TFRs. An unsalvageable TFR was defined as an infected TFR that resulted in a hip disarticulation, hemipelvectomy, or removal of the TFR with no ability to reimplant the endoprosthesis. A salvageable TFR was defined as an infected TFR that was successfully retained. The indications for amputation were for patients who had infected TFRs that could not be managed by antibiotics or surgery and further surgical or medical intervention was deemed to be ineffective.

Statistical analysis was performed using the Fischer’s exact test, and a P value of <.05 was considered statistically significant when risk factors were assessed.

Results

There were 24 patients with TFRs seen at our institution between 2000 and 2010. Fourteen of these patients were not included in this study due to a lack of history of periprosthetic infection. Of the 10 patients who had TFRs with periprosthetic infections, 5 were women and 5 were men and their mean age was 44.3 years (range, 9-78 years).

Four of the tenpatients received primary TFRs. Three of these patients were diagnosed with osteosarcoma, and 1 was diagnosed with Ewing’s sarcoma. Six patients received secondary TFRs. Of these, 4 had failed total hip arthroplasties secondary to periprosthetic infection, 1 had a failed proximal femoral replacement secondary to aseptic loosening, and 1 had a failed distal femoral replacement secondary to periprosthetic fracture. Mean postoperative follow-up for the patients with infected TFRs was 10.5 months (range, 3-22 months). Patients who had unsalvageable TFRs had a mean of 12 weeks from last surgery to amputation. For the 3 patients with salvaged TFRs, follow-up time following treatment of the infection was 6, 34, and 36 months, respectively. One patient succumbed to his primary disease, osteosarcoma, within 6 months of his periprosthetic infection.

In 9 of 10 patients, positive cultures were found consisting of the following microorganisms: coagulase-negative Staphylococci (n=4), Enterococcus species (n=3), Staphylococcus aureus (n=1), and Pseudomonas aeruginosa (n=1). The 1 patient with negative cultures had histological evidence of osteomyelitis, as well as pain and persistent fluid collection around the TFR.

Seven of 10 unsalvageable TFRs were due to infection. The 2 greatest risk factors for unsalvageable TFRs were age older than 50 years (Figure 1) and recipients of secondary TFRs (Figure 2). All 6 patients older than 50 years had unsalvageable TFRs, whereas 1 of 4 patients younger than 50 years had an unsalvageable TFR (P<.05). Similarly, all 6 patients who received secondary TFRs had unsalvageable TFRs, whereas 1 of 4 patients who received a primary TFR had an unsalvageable TFR (P<.05). All results are shown in the Table.

Percentage of salvageable and unsalvageable TFRs in patients younger than 50 years vs patients 50 years and older. Figure 1: Percentage of salvageable and unsalvageable TFRs in patients younger than 50 years vs patients 50 years and older.

Percentage of salvageable and unsalvageable TFRs in primary vs secondary TFRs. Figure 2: Percentage of salvageable and unsalvageable TFRs in primary vs secondary TFRs.

Results of Risk Factor Analysis for Unsalvageable TFR Following Periprosthetic Infection Table: Results of Risk Factor Analysis for Unsalvageable TFR Following Periprosthetic Infection

Sex, number of irrigation and debridements, recent history of a periprosthetic infection, early vs late periprosthetic infection after TFR surgery, use of antibiotic cement, and number of postoperative antibiotics did not show statistical significance and could not be identified as possible risk factors (Table).

Discussion

Prior to the use of TFRs, treatment following a massive resection of the femur was limited to limb amputation, leaving patients with functional deficits of the lower limb. 6 The development of endoprosthesis in limb salvaging has allowed for the TFR to become an accepted method of treatment following large resections of the femur. This allows physicians to preserve significant function in the lower extremities of their patients. 1,9 Although no evidence of improvement in either quality of life or survival when comparing limb salvaging to amputation exists, 11 studies have shown overall functional improvement of the salvaged limbs prior to the patient having surgery. 7,8,15,16

The complexity of the TFR procedure, as well as the high-risk nature of the patient population (eg, immunocompromised individuals, elderly) in which the treatment has been used led to predictable complications. The complications typically seen with TFRs include dislocation of the hip, superficial and deep infection, periprosthetic fracture, local recurrence of tumor, and joint pain. Of these complications, tumor recurrence and deep wound infection have been shown to increase the risk of amputation. 8,17-19

Studies have shown infection rates in TFRs to be between 3% and 36.7%. 5-8,12,16,18,20 In a large study of orthopedic oncologic patients by Jeys et al, 17 the researchers reported that individuals with infected endoprosthesis had a 19% rate of amputation due to infection. Due to the lack of large TFR case studies, the percentage of unsalvageable TFRs caused by infection has never been properly addressed. Our studies demonstrated a significant number of unsalvageable TFRs following infection (70%), thus making the understanding of risk factors for unsalvageable TFR following infection important.

The current study examined multiple possible risk factors, including age, sex, secondary TFRs, number of irrigation and debridements, recent history of periprosthetic infection, early vs late infection, use of antibiotic cement, and number of postoperative antibiotics. From these variables, patients older than 50 years and receipt of secondary TFRs had the greatest risks for an unsalvageable TFR following a periprosthetic infection.

Ward et al 6 reported 3 cases of deep tissue infection in their study of 21 cases of TFRs. Two of 3 patients, both older than 50 years, needed hip disarticulations, whereas the remaining 1 (aged 26 years) resulted in a salvaged TFR. Nerubay et al 12 also reported the case of a 55-year-old patient with a deep tissue infection among the 19 cases of TFRs that could not be controlled and resulted in amputation. These studies, along with the current study, suggest that an older age poses a greater risk for unsalvageable TFR following a periprosthetic infection. The increased risk for unsalvageable TFRs following periprosthetic infection in the older population can be attributed to multiple factors (eg, decreased immuno-responsiveness, greater comorbidities, and difficulties in activities of daily life). These factors were not assessed in this study.

In a study of revision arthroplasty to TFR by Frieseke et al, 18 the researchers found the rate of unsalvageable TFRs following periprosthetic infections to be 17%, with all patients having negative cultures for microorganisms at the time of revision surgery. These patients received TFRs due to failure of their original endoprosthesis. Although our rate of unsalvageable secondary TFRs following periprosthetic infections was found to be much higher, 4 of the 10 patients in our study had a recent infection of their endoprosthesis that necessitated the need for conversion to TFRs. This factor may contribute to the higher rate of incidence of unsalvageable secondary TFRs following periprosthetic infections.

The study by Ward et al 6 on TFRs reported 8 cases of TFRs that were used following failed subtotal femoral endoprosthesis. Two of these patients had periprosthetic infections following their surgical revision to TFRs, and of these 2 patients, 1 had an unsalvageable TFR. Although both studies demonstrated lower rates of unsalvageable TFRs than the authors’ study, they both demonstrate concerning rates of unsalvageable TFRs when TFRs are used as revision surgeries and are then followed by periprosthetic infections. One possible reason for this high rate of unsalvageable TFRs could be that multiple endoprosthetic surgeries, as well as periprosthetic infections, may cause soft tissue damage, making proper soft tissue coverage difficult. Studies by Hardes et al 21 and Grimer et al 22 reported that inadequate soft tissue coverage in tumor patients with endoprosthesis poses a higher risk of implant failure following infection.

Although other risk factors were studied in the authors’ research, these did not show statistical significance. The authors note that, although not statistically significant, all individuals who had recent histories of deep tissue infections at the time of initial TFR surgery and went on to have infected TFR had unsalvageable TFRs (n=4).

There are several limitations to the current study. Due to the specific inclusion criteria of this study, the research was restricted to a small number of cases. This made enhanced statistical analyses, such as multivariant analysis, difficult. Also, it should be noted that the lack of statistical significance in multiple risk factors in this study may be the result of the limited sample size and not a clear indication that these risk factors did not at all influence the failure rates of TFRs. In addition, the small number of cases also limited the authors’ ability to assess comorbidities that influence infection, such as smoking, diabetes mellitus, and rheumatoid arthritis. Finally, this study included patients with varying diseases (oncologic and nononcologic), with each patient having a different disease process. Due to the brief follow-up time and the limited number of patients, the effect of each disease on TFRs could not be addressed.

The authors stress the importance of evaluating risk factors for unsalvageable TFRs. Patients who may fall into high-risk categories (those older than 50 years and recipients of secondary TFRs) may benefit from physician education regarding the advantages of early interventions, such as amputation, that could prevent additional surgeries and decrease the lengths of hospitalizations. In addition, preventing infection in TFRs in all patients is important, but particularly so in patients who have a higher risk for unsalvageable TFRs following periprosthetic infection.

References

    1. Bielack SS, Kempf-Bielack B, Delling G, et al. Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols. J Clin Oncol. 20(3):776-790.

    1. Schwartz HS. Musculoskeletal Tumor Society. In: Herbert S, Schwartz HS, eds. Orthopaedic Knowledge Update: Musculoskeletal Tumors 2. 2nd ed. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2007:143-205.

    1. Unni KK, Inwards CY. Dahlin’s Bone Tumors: General Aspects and Data on 10,165 Cases. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2010.

    1. Gibbs CP Jr, Weber K, Scarborough MT. Malignant bone tumors. Instr Course Lect. 2002; 51:413-428.

    1. Bickels J, Meller I, Henshaw R, Malawar MM. Proximal and Total Femur Resection with Endoprosthetic Reconstruction. In: Malawar MM, Sugarbaker PH, eds. Musculoskeletal Cancer Surgery. Treatment of Sarcomas and Allied Diseases. Boston, MA: Kluwer; 2001:438-456.

    1. Ward WG, Dorey F, Eckardt JJ. Total femoral endoprosthetic reconstruction. Clin Orthop Relat Res. 1995; (316):195-206.

    1. Ruggieri P, Bosco G, Pala E, Errani C, Mercuri M. Local recurrence, survival and function after total femur resection and megaprosthetic reconstruction for bone sarcomas. Clin Orthop Relat Res. 2010; 468(11):2860-2866. doi:10.1007/s11999-010-1476-4 [CrossRef]

    1. Sewell MD, Spiegelberg BG, Hanna SA, et al. Total femoral endoprosthetic replacement following excision of bone tumours. J Bone Joint Surg Br. 2009; 91(11):1513-1520. doi:10.1302/0301-620X.91B11.21996 [CrossRef]

    1. Freedman EL, Eckardt JJ. A modular endoprosthetic system for tumor and non-tumor reconstruction: preliminary experience. Orthopedics. 1997; 20(1):27-36.

    1. Grimer RJ, Carter SR, Pynsent PB. The cost-effectiveness of limb salvage for bone tumours. J Bone Joint Surg Br. 1997; 79(4):558-561. doi:10.1302/0301-620X.79B4.7687 [CrossRef]

    1. Refaat Y, Gunnoe J, Hornicek FJ, Mankin HJ. Comparison of quality of life after amputation or limb salvage. Clin Orthop Relat Res. 2002; (397):298-305. doi:10.1097/00003086-200204000-00034 [CrossRef]

    1. Nerubay J, Katznelson A, Tichler T, Rubinstein Z, Morag B, Bubis JJ. Total femoral replacement. Clin Orthop Relat Res. 1988; (229):143-148.

    1. Lavoie G, Healey HJ, Lane JM, Marcove RC. Prosthetic total femur replacement following massive resection for sarcoma. In: Brown K, ed. Complications of Limb Salvage: Prevention, Management, and Outcomes. Montreal, Quebec, Canada: ISOLS; 1991:129-132.

    1. Tattevin P, Crémieux AC, Pottier P, Huten D, Carbon C. Prosthetic joint infection: when can prosthesis salvage be considered? Clin Infect Dis. 1999; 29(2):292-295. doi:10.1086/520202 [CrossRef]

    1. Ahmed AR. Total femur replacement [published online ahead of print July 31, 2009]. Arch Orthop Trauma Surg. 2010; 130(2):171-176. doi:10.1007/s00402-009-0945-2 [CrossRef]

    1. Fountain JR, Dalby-Ball J, Carroll FA, Stockley I. The use of total femoral arthroplasty as a limb salvage procedure: the Sheffield experience. J Arthroplasty. 2007; 22(5):663-669. doi:10.1016/j.arth.2006.11.017 [CrossRef]

    1. Jeys LM, Grimer RJ, Carter SR, Tillman RM. Risk of amputation following limb salvage surgery with endoprosthetic replacement, in a consecutive series of 1261 patients [published online ahead of print February 8, 2003]. Int Orthop. 2003; 27(3):160-163.

    1. Friesecke C, Plutat J, Block A. Revision arthroplasty with use of a total femur prosthesis. J Bone Joint Surg Am. 2005; 87(12):2693-2701. doi:10.2106/JBJS.D.02770 [CrossRef]

    1. Ghert MA, Harrelson JM, Scully SP. Total femoral replacement. Oper Tech Orthop. 1999; 9(2):121-127. doi:10.1016/S1048-6666(99)80031-7 [CrossRef]

    1. Henderson ER, Groundland JS, Pala E, et al. Failure mode classification for tumor endoprostheses: retrospective review of five institutions and a literature review. J Bone Joint Surg Am. 2011; 93(5):418-429. doi:10.2106/JBJS.J.00834 [CrossRef]

    1. Hardes J, Gebert C, Schwappach A, et al. Characteristics and outcome of infections associated with tumor endoprostheses [published online ahead of print April 21, 2006]. Arch Orthop Trauma Surg. 2006; 126(5):289-296. doi:10.1007/s00402-005-0009-1 [CrossRef]

  1. Grimer RJ, Belthur M, Chandrasekar C, Carter SR, Tillman RM. Two-stage revision for infected endoprostheses used in tumor surgery. Clin Orthop Relat Res. 2002; (395):193-203. doi:10.1097/00003086-200202000-00022 [CrossRef]

Blaze Bioscience Licenses Tumor Paint Technology from Fred Hutchinson Cancer Research Center

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Posted 19 Oct 2011 — by James Street
Category Osteosarcoma surgery
 press release

Oct. 18, 2011, 8:00 a.m. EDT

 

SEATTLE, Oct 18, 2011 (BUSINESS WIRE) — Blaze Bioscience, Inc., a biotechnology company dedicated to developing products that assist surgeons in their quest to improve the lives of cancer patients, announced today that the company entered into a Patent and Technology License Agreement with Fred Hutchinson Cancer Research Center (Hutchinson Center) in Seattle. Under the terms of the agreement, the company obtained a royalty-bearing, exclusive, worldwide license to certain patent and technology rights that enable development and commercialization of Tumor Paint technology, as well as access to other rights related to the technology.

Tumor Paint technology, which originated in the laboratory of Dr. Jim Olson, a member of the Clinical Research Division at the Hutchinson Center, was developed to provide real-time intraoperative visualization of cancer cells, enabling better detection and surgical resection of solid tumors without injuring healthy surrounding tissue. This is particularly significant in the brain, where approximately 80% of cancers recur at the edges of the surgical sites and where preserving vital healthy tissue significantly improves patient safety. Dr. Olson is a scientific founder of Blaze Bioscience and a pediatric neuro-oncologist at Seattle Children’s Hospital. His research focuses on development of effective therapeutics and diagnostics for cancer patients and has led to four national clinical trials for children with brain tumors.

“Neurosurgeons have been working for decades to find a better way to distinguish tumor tissue from normal brain,” said Dr. Olson. “Tumor Paint is a powerful tool in the fight against brain and other cancers and has the potential to fundamentally transform surgical oncology.”

“The Tumor Paint technology has been developed by the Olson lab with a view to quick entry into the clinic and broad applicability to multiple cancers. The fundamental research work has been completed and the Blaze Bioscience team is poised to initiate IND-enabling activities for CyTP 007, the lead Tumor Paint product, in 2012,” said Heather Franklin, CEO and President of Blaze Bioscience.

About Blaze Bioscience, the Tumor Paint Company

Blaze Bioscience, Inc. is a Seattle-based, privately-held biotechnology company dedicated to developing products that assist surgeons in their quest to improve the lives of cancer patients. The company was founded in 2010 to develop and commercialize the Tumor Paint technology. The first Tumor Paint product candidate, CyTP 007, is under development for brain cancer and other solid tumors. CyTP 007 is a combination of a targeting peptide and a fluorescent beacon. For additional information, please visit www.blazebioscience.com .

SOURCE: Blaze Bioscience, Inc.

        
        Blaze Bioscience, Inc. 
        Heather Franklin, CEO and President 
                    206-849-3647       
        Heather.Franklin@blazebioscience.com

Purdue technology used in first fluorescence-guided ovarian cancer surgery

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Posted 19 Sep 2011 — by James Street
Category Osteosarcoma surgery, Ovarian, Physics and Engineering, Thoracic Surgery

IMAGE: This is a surgeon’s view of ovarian cancer cells with and without the tumor-targeted fluorescent imaging agent.

Click here for more information.

WEST LAFAYETTE, Ind. – The first fluorescence-guided surgery on an ovarian cancer patient was performed using a cancer cell “homing device” and imaging agent created by a Purdue University researcher.

The surgery was one of 10 performed as part of the first phase of a clinical trial to evaluate a new technology to aid surgeons in the removal of malignant tissue from ovarian cancer patients. The method illuminates cancer cells to help surgeons identify and remove smaller tumors that could otherwise be missed.

Philip Low, the Ralph C. Corely Distinguished Professor of Chemistry who invented the technology, said surgeons were able to see clusters of cancer cells as small as one-tenth of a millimeter, as opposed to the earlier average minimal cluster size of 3 millimeters in diameter based on current methods of visual and tactile detection.

“Ovarian cancer is notoriously difficult to see, and this technique allowed surgeons to spot a tumor 30 times smaller than the smallest they could detect using standard techniques,” Low said. “By dramatically improving the detection of the cancer – by literally lighting it up – cancer removal is dramatically improved.”

The technique attaches a fluorescent imaging agent to a modified form of the vitamin folic acid, which acts as a “homing device” to seek out and attach to ovarian cancer cells. Patients are injected with the combination two hours prior to surgery and a special camera system, called a multispectral fluorescence camera, then illuminates the cancer cells and displays their location on a flat-screen monitor next to the patient during surgery.

The surgeons involved in this study reported finding an average of 34 tumor deposits using this technique, compared with an average of seven tumor deposits using visual and tactile observations alone. A paper detailing the study was published online Sunday (Sept. 18) in Nature Medicine.

Gooitzen van Dam, a professor and surgeon at the University of Groningen in The Netherlands where the surgeries took place, said the imaging system fits in well with current surgical practice.

“This system is very easy to use and fits seamlessly in the way surgeons do open and laparoscopic surgery, which is the direction most surgeries are headed in the future,” said van Dam, who is a surgeon in the division of surgical oncology and Bio-Optical Imaging Center at the University of Groningen. “I think this technology will revolutionize surgical vision. I foresee it becoming a new standard in cancer surgery in a very short time.”

Research has shown that the less cancerous tissue that remains, the easier it is for chemotherapy or immunotherapy to work, Low said.

“With ovarian cancer it is clear that the more cancer you can remove, the better the prognosis for the patient,” he said. “This is why we chose to begin with ovarian cancer. It seemed like the best place to start to make a difference in people’s lives.”

By focusing on removal of malignant tissue as opposed to evaluating patient outcome, Low dramatically reduced the amount of time the clinical trial would take to complete.

“What we are really after is a better outcome for patients, but if we had instead designed the clinical trial to evaluate the impact of fluorescence-guided surgery on life expectancy, we would have had to follow patients for years and years,” he said. “By instead evaluating if we can identify and remove more malignant tissue with the aid of fluorescence imaging, we are able to quantify the impact of this novel approach within two hours after surgery. We hope this will allow the technology to be approved for general use in a much shorter time.”

Low and his team are now making arrangements to work with the Mayo Clinic for the next phase of clinical trials.

The technology is based on Low’s discovery that folic acid, or folate, can be used like a Trojan horse to sneak an imaging agent or drug into a cancer cell. Most ovarian cancer cells require large amounts of the vitamin to grow and divide, and special receptors on the cell’s surface grab the vitamin – and whatever is linked to it – and pull it inside. Not all cancer cells express the folate receptor, and a simple test is necessary to determine if a specific patient’s cancer expresses the receptor in large enough quantities for the technique to work, he said.

IMAGE: Philip Low is pictured here in the lab.

Click here for more information.

Ovarian cancer has one of the highest rates of folate receptor expression at about 85 percent. Approximately 80 percent of endometrial, lung and kidney cancers, and 50 percent of breast and colon cancers also express the receptor, he said.

Low also is investigating targeting molecules that could be used to carry attached imaging agents or drugs to forms of cancer that do not have folate receptors.

He next plans to develop a red fluorescent imaging agent that can be seen through the skin and deep into the body. The current agent uses a green dye that had already been through the approval process to be used in patients, but cannot easily be seen when present deep in tissue. Green light uses a relatively short wavelength that limits its ability to pass through the body, whereas the longer wavelengths of a red fluorescent dye can easily be seen through tissue.

“We want to be able to see deeper into the tissue, beyond the surface,” Low said. “Different cancers have tumors with different characteristics, and some branch and wind their way deeper into tissue. We will continue to evolve this technology and make improvements that help cancer patients.”

In addition to Low and van Dam, the paper’s authors include George Themelis, Athanasios Sarantopoulos and Vasilis Ntziachristos of the Institute for Biological and Medical Imaging at the Technical University of Munich in Germany; Lucia Crane, Niels Harlaar, Rick Pleijhuis, Wendy Kelder and Johannes de Jong of the division of surgical oncology of the BioOptical Imaging Center at the University of Groningen; Henriette Arts and Ate van der Zee of the division of gynaecological oncology at the University of Groningen; and Joost Bart of the Department of Pathology and Molecular Biology of the University Medical Center of Groningen.

Low is the chief science officer for Endocyte Inc., a Purdue Research Park-based company that develops receptor-targeted therapeutics for the treatment of cancer and autoimmune diseases. Endocyte holds the license to the folate receptor-targeting technology and is spinning this technology off into a new company called OnTarget.

Ntziachristos led the team at the Technical University of Munich that developed the camera system. A startup company named SurgOptix BV is working to commercialize the camera system.

###

The clinical trial was funded by Endocyte Inc. and the University Medical Center of Groningen.

Writer: Elizabeth K. Gardner, 765-494-2081, ekgardner@purdue.edu

Sources: Philip Low, 765-494-5273, plow@purdue.edu Gooitzen van Dam, 31-50-3612283, g.m.van.dam@chir.umcg.nl

Related website: Philip Low research page: http://www.chem.purdue.edu/low/

VIDEO CAPTION:

Fluorescence-guided surgery on an ovarian cancer patient is shown.

Video is available at http://www.youtube.com/watch?v=CcUFTLVonqs

IMAGE CAPTION:

A surgeon’s view of ovarian cancer cells with and without the tumor-targeted fluorescent imaging agent. (Image courtesy of Philip Low)

A publication-quality image is available at http://news.uns.purdue.edu/images/2011/low-fluorescent.jpg

PHOTO:

Philip Low – http://news.uns.purdue.edu/images/2011/low-labshot.jpg

Abstract on the research in this release is available at: http://www.purdue.edu/newsroom/research/2011/110918LowSurgery.html

Synthes and Lilly Sign Development and Collaboration Agreement

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Posted 09 Jun 2011 — by James Street
Category Bone repair, Limb and organ Regeneration, Methotrexate, Osteosarcoma surgery

WEST CHESTER, Pa. and INDIANAPOLIS, June 9, 2011 /PRNewswire/ — Synthes, Inc. (SIX: SYST.VX) and Eli Lilly and Company (NYSE: LLY) today announced the signing of an exclusive worldwide collaboration agreement to address the needs of patients who are cared for by orthopedic surgeons, including those with osteoporosis and those with bone fractures.

The agreement allows for the joint development and licensing of early stage compounds from Lilly to Synthes for use within orthopedic trauma, spine, craniomaxillofacial and reconstructive areas. These compounds have pre-clinical and in some cases clinical data packages and have the potential to aid in the local treatment and regeneration of the skeleton. The two companies will jointly develop site-specific osteoinductive (i.e. bone healing) products based on Synthes’ biomaterials combined with Lilly’s biologics or pharmaceuticals.

Within a second development program, Synthes and Lilly will jointly conduct and fund the evaluation of additional orthopedic uses for Lilly’s osteoporosis drug Forteo® (teriparatide [rDNA origin] injection), marketed as Forsteo® in some countries outside of the United States).  Building upon a Phase II study that Lilly has already completed, Lilly and Synthes will collaborate on additional clinical studies to evaluate potential future indications for Forteo, including fracture healing.

In addition to the development component of the agreement, the collaboration also includes the U.S. co-promotion of Forteo to orthopedic surgeons, an important segment of physicians who treat patients with a fracture due to osteoporosis. The companies will also co-promote Forteo in select countries and regions outside of the United States.

“I am very excited about this unique collaboration that will utilize the complementary clinical, development and operational strengths of each partner,” said Michel Orsinger, president and CEO of Synthes. “Osteoporosis is one of the most significant unsolved clinical problems in orthopedics. Addressing the osteoporosis disease as well as the resulting fracture and bone defect is a significant strategic priority of both organizations,” he continued. “Strategic collaborations between medtech and pharma companies represent a new and promising avenue to develop and market true innovations in a changing, dynamic market environment.”

“We believe that patients worldwide will benefit from this collaboration because together we will be able to look for new ways to treat osteoporosis and bone fractures,” said Bryce Carmine, executive vice president and president, Lilly Bio-Medicines, Eli Lilly and Company. “At Lilly, we are always exploring new opportunities to bring innovative medicines to people with unmet medical needs and improve outcomes for individual patients.”

“Many orthopedic surgeons are in the position to diagnose and treat osteoporosis when their patients present with fractures, and we believe it is imperative to treat the underlying cause of the initial fracture,” said Johnston Erwin, Bone/Muscle/Joint global development platform leader, Lilly Bio-Medicines, Eli Lilly and Company. “Our collaboration will also explore ways to treat fractures with Forteo in older patients and/or those who have osteoporosis and, longer term, will look for new ways to deliver medicine locally to the fracture site.”

Financial terms of the agreement have not been disclosed.

Forteo, an FDA-approved osteoporosis therapy to help build new bone, is a treatment for postmenopausal women with osteoporosis who are at high risk for fracture(1) and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.(2) Individuals at high risk for having broken bones include men and women with either a history of broken bones due to osteoporosis, who have several risk factors for fracture, or who cannot use other osteoporosis treatments.(1) Forteo is also approved to treat men and women with osteoporosis associated with sustained, systemic glucocorticoid therapy at high risk for fracture.(3) Forteo is a prescription medicine given as a 20 mcg once daily dose(4) available in a 2.4 mL prefilled delivery device for subcutaneous injection over 28 days.(5)

During the drug testing process, the medicine in Forteo caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took Forteo, and it is unknown if people who take Forteo have a higher chance of getting the disease. Before patients take Forteo, patients should tell their healthcare provider if they have Paget’s disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy.(6) For more information about Forteo, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.

About Eli Lilly and Company

Eli Lilly and Company, a leading innovation-driven company, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’s most urgent medical needs. Information about Lilly is available at www.lilly.com.

Synthes: A leading medical device company

Synthes is a leading global medical device company, specialized in the development, manufacturing and marketing of instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.

Important Safety Information about FORTEO

What is the most important information I should know about FORTEO?

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget’s disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy

Who should not take FORTEO?

  • You should not take FORTEO for more than 2 years over your lifetime.

 

  • Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

 

What should I tell my healthcare provider before taking FORTEO?

  • Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.

 

  • You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.

What are the possible side effects of FORTEO?

  • FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

 

  • Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising.  These are not all the possible side effects of FORTEO.  You are encouraged to report negative side effects of Prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call             1-800-FDA-1088 begin_of_the_skype_highlighting 1-800-FDA-1088 end_of_the_skype_highlighting .

 

Additional safety information about FORTEO

  • There is a voluntary patient registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call             1-866-382-6813 begin_of_the_skype_highlighting 1-866-382-6813 end_of_the_skype_highlighting or go to www.forteoregistry.org.

 

  • The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO Delivery Device at any one time. Do not transfer the medicine from the FORTEO Delivery Device to a syringe. This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

 

How should I store FORTEO?

  • Keep your FORTEO Delivery Device in the refrigerator between 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C). Do not freeze the FORTEO Delivery Device. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it (see the User Manual).

 

For more safety information, please see Medication Guide (http://pi.lilly.com/us/forteo-medguide.pdf) and Prescribing Information, including Boxed Warning (http://pi.lilly.com/us/forteo-pi.pdf).  Please see full user manual that accompanies the delivery device.

TE Con ISI  07Mar2011

This press release contains certain forward-looking statements about the collaboration between Synthes and Lilly and about Forteo for the treatment of osteoporosis in patients who are at high risk for a fracture. It reflects Synthes’ and Lilly’s current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will be commercially successful. There is also no guarantee that the collaboration will be successful. For further discussion of these and other risks and uncertainties, see Lilly’s filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

The securities of Synthes have been offered and sold outside the United States and have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”). Such securities may not be offered, sold or transferred in the U.S. or to U.S. Persons (as defined in the regulations of the Securities Act), except pursuant to a registration statement filed under the Securities Act or under an applicable exemption under the Securities Act. Hedging transactions involving such securities may not be conducted unless in compliance with the Securities Act. The Synthes securities are deemed “Restricted Securities” as that term is defined in Rule 144 under the Securities Act.

FORTEO® and FORSTEO® are registered trademarks of Eli Lilly and Company.

P-LLY

(Logo:  http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

(Logo:  http://photos.prnewswire.com/prnh/20110609/DE15577LOGO )

(1)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.1. Accessed on April 21, 2011.

(2)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.2. Accessed on April 21, 2011.

(3)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.3. Accessed on April 21, 2011.

(4)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Sections 2.1, 2.2, 2.3. Accessed on April 21, 2011.

(5)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 3, Section 3. Accessed on April 21, 2011.

(6)  FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 3, Section 5.1. Accessed on April 21, 2011.

SOURCE Eli Lilly and Company

Leg attached backward lets teen Dugan Smith return from cancer treatment to ballfield

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Posted 09 May 2011 — by James Street
Category Artificial Knees and implants, Artificial limbs, Bone repair, Osteosarcoma surgery
Published: Monday, May 09, 2011, 3:46 PM     Updated: Monday, May 09, 2011, 4:30 PM

By Plain Dealer staff

FOSTORIA, Ohio — A rare and radical surgery is helping a 13-year-old Fostoria boy survive bone cancer and keep up an active life with the healthy parts of his right leg, doctors told his hometown paper.

In 2008, when he was 10, Dugan Smith was diagnosed with osteosarcoma, the most common bone cancer in children. His knee and part of his thigh had to be amputated. But rather than have his movements limited, Dugan opted for “rotationplasty,” which turned his lower leg around, attached it to the remainder of his thigh and allowed his ankle to take over in place of his knee.

The Tiffin Advertiser-Tribune began the story in 2008.

In April, the Columbus Dispatch picked up the tale:

Less than three years after doctors from Ohio State University Medical Center amputated much of his right leg to remove a softball-size tumor from above his right femur (thighbone), Dugan plays baseball and basketball, went skiing last week, and plans to go out for freshman football in the fall.

The Fostoria Review-Times explained more last week:

“The foot fits into a prosthetic and allows him to expend much less energy walking than if he had opted to simply amputate the diseased portion of his leg.”

But the leg does look strange.

“Initially, they were just like any one would be when you describe the surgery, they were taken aback,” Dr. Joel Mayerson, an orthopedic oncologist at the Arthur G. James Cancer Hospital told the R-T. “But, they understood it would bring Dugan back to the most functional state.”

“… For Dugan, it was a no-brainer.”

Now an unusually determined seventh-grader, Dugan pitches and plays first base for the Fostoria Junior Redmen, and continues to work to strengthen his hip and leg.

An Ohio State Medical Center oncologist talks about the case: