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U-M CCC - Progress Newsletter Summer 2003 Online

Research Roundup - Bexxar therapy receives FDA panel support

See Also:: Early Detection Procedure Can Help More Melanoma Patients Than Previously Thought

An advisory panel to the U.S. Food and Drug Administration (FDA) recently lent strong support for a cancer treatment developed and tested at the University of Michigan. Although final approval by the FDA for marketing in the U.S. is not guaranteed based on the panel's recommendation, the determination announced in December, 2002is a strong step in the direction of approval, according to Mark Kaminski, M.D., co-director of the Leukemia/ Lymphoma/Blood and Marrow Transplant Program at the U-M Comprehensive Cancer Center.

The treatment, called Bexxar (tositumomab and iodine I-131 tositumomab) therapy, was originally conceived and developed by Dr. Kaminski and U-M nuclear medicine pioneer Richard Wahl, M.D. It was further developed in collaboration with scientists at Coulter Corp., a company later acquired by Corixa Corp. Dr. Kaminski has led several clinical trials of Bexxar that provided clinical evidence of its efficacy. Dr. Wahl is now chair of nuclear medicine at Johns Hopkins University Medical Center.

Designed to precisely target certain cancerous cells with radiation while sparing non-cancerous areas, it has shown great promise in the treatment of non-Hodgkin's lymphoma, including after chemotherapy failure.

Bexxar combines a mouse monoclonal antibody to which radioactive iodine 131 is attached. This radioactive antibody locks on to a protein called CD20 found only on the surface of the blood's B-cells, including those that have turned malignant in non-Hodgkin's lymphoma patients.

The treatment works through a combination of immune system activity involving the monoclonal antibody and effects from the radiation released by the iodine 131. Through this targeted approach, the cancer cells receive a greater concentration of therapeutic radiation while minimizing radiation exposure to normal tissues.

Non-Hodgkin's lymphoma (NHL) is a form of cancer that affects the blood and lymphatic tissues. The sixth leading cause of cancer death in the U.S., NHL also has the second fastest-growing incidence rate of all cancers. According to the National Cancer Institute, nearly 300,000 Americans have NHL, among them 140,000 with the low-grade or transformed low-grade forms of the disease. In more than 30 years, the survival rates of low-grade NHL patients have not changed, and patients continue to die from the disease or complications associated with current treatments.

The complete news release is available on-line.

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Early detection procedure can help more melanoma patients than previously thought

Patients who develop melanoma on their face, head or neck can have the same early-diagnosis surgical procedure to see if their cancer might spread as patients whose cancer is on less delicate areas of the body, a new study finds.

The report, from a team at the University of Michigan Comprehensive Cancer Center, opens the door for many more melanoma patients to benefit from a potentially life-saving technique called sentinel lymph node mapping. The results were published in the January issue of Archives of Otolaryngology, a journal of the American Medical Association.

Many hospitals already use sentinel lymph node mapping to assess the threat of melanoma in patients with lesions on their arms, trunk or legs. The technique shows whether cancer cells have entered nearby lymph nodes and might spread further, and helps doctors and patients decide how aggressive treatment should be.

But fear of damaging the delicate nerves and blood vessels concentrated in the head and neck has kept many physicians from using the technique on patients with cancer on their scalp, face or neck - nearly one-fifth of the 87,900 melanoma patients diagnosed each year. As a result, many patients may be receiving inadequate treatment.

The new results, from 80 patients treated through the U-M's noted melanoma (also known as Cutaneous Oncology) program and followed for at least a year after mapping, show that the technique can be performed safely and yield the same information in these patients as in others.

More than 96 percent of patients were successfully mapped, and 18 percent were shown to have melanoma that had spread to a lymph node -- giving them a diagnosis much sooner than a standard routine examination would have. The false-negative rate was 4.5 percent.

"These results clearly show that patients with melanoma of the head and neck can be accurately staged through sentinel lymph node mapping, allowing very early detection of even minimal disease in the lymph nodes,"says author Carol Bradford, M.D., who directs the U-M Head and Neck Oncology Program. "Although the technique is the most challenging in these patients, we now know it can be done, and done safely."

The authors hope the technique will become standard for all appropriate melanoma patients. But they caution that to be accurate, the procedure requires a great deal of experience and expertise on the part of the team of surgeons, nuclear medicine specialists and pathologists required to carry it out.

"Sentinel lymph node mapping is one of the most important advances in melanoma management in the last decade, but there has been a question of whether it can be applied to the head and neck,"says co-author Timothy M. Johnson, M.D., who heads the U-M Multidisciplinary Melanoma Program. That program sees more than 1,300 new melanoma patients each year, more than half the cases in Michigan.

"Our program has evolved, in partnership with the private-practice physician community, to provide optimal, high-quality state-of-the-art patient care that is also cost-effective,"Johnson explains. But, he feels, the ability to perform sentinel lymph node mapping in head-and-neck melanoma patients exists or could be developed at other major cancer centers.

The complete news release is available on-line.

Also in Research Roundup:
Early Detection Procedure Can Help More Melanoma Patients Than Previously Thought


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