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​Gemcitabine Demonstrates Promise As A Low Toxic Chemotherapeutic Agent For Patients With Bladder Cancer

ORLANDO, May 16, 2002 — Patients with bladder cancer could benefit from treatment with gemcitabine (Gemzar®), a chemotherapeutic agent that has been used successfully to treat pancreatic cancer and non-small cell lung cancer, according to phase I trial results reported at the 38th Annual Meeting of the American Society for Clinical Oncology (ASCO).

The study, presented by Merrill J. Egorin, M.D., professor of medicine and pharmacology, University of Pittsburgh Cancer Institute (UPCI), demonstrated that little, if any, toxicity was associated with gemcitabine in patients who received it intravesically (through a tube inserted in the urethra) to treat early stage bladder cancer.

"Many patients with bladder cancer are at high risk for relapse," said Dr. Egorin. "In fact, 50 to 80 percent of bladder cancer patients suffer a recurrence of the disease within three years and current standard treatments often cause toxic side effects. As a result, there is a need for the development and application of new agents that destroy cancer cells in the bladder but do not cause serious adverse effects. Gemcitabine, as an antimetabolite that interferes with cancer cells by slowing their growth and spread through the body, shows early promise as one such agent."

Dr. Egorin explained that toxic effects associated with standard treatment for bladder cancer can include fever, chills, flu-like symptoms, burning upon urination and reduced white blood cell counts.

The study included 15 patients with superficial, or early stage, bladder cancer. The patients received gemcitabine in doses of 500, 1000, 1500 and 2000 mg. The results demonstrated that either no or very low levels of gemcitabine were found in plasma samples from patients, indicating that only a small amount of gemcitabine was absorbed systemically into the blood. The results also demonstrated that in individual patients, doses absorbed correlated well with doses recovered in patients' urine. These results further defined the appropriate dose for a phase II trial of gemcitabine in superficial bladder cancer and such a trial is ongoing. A large phase III trial designed to fulfill FDA requirements for approval of gemcitabine as a treatment for superficial bladder cancer is planned.

A difficult cancer to treat due to high rates of recurrence, bladder cancer is newly-diagnosed in 55,000 people in the United States each year and an estimated 12,500 deaths occur annually.

Co-investigators of the study include Eleanor G. Zuhowski, B.S., from UPCI; Menachem Laufer, M.D., and Ofer Nativ from Bnai-Zion Medical Center; and Irene Trueheart, R.N., Mary Ellen Haisfield-Wolfe, R.N., Mario Eisenberger, M.D., and Mark Schoenberg, M.D., from Johns Hopkins Hospital. Support for the study was provided by Eli Lilly.

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