Study Raises New Hope for Chemotherapy

At last, definitive news: Chemotherapy prolongs life in men with prostate cancer-and it may be most effective when it is started early, and used aggressively. This is the word from a massive, worldwide study of 1006 men with hormone-refractory cancer, led by Mario Eisenberger, M.D., the R. Dale Hughes Professor of Oncology and Urology, published in the New England Journal of Medicine.

The results come after years of clinical trials, of dozens of chemotherapy compounds and drug regimens-many of them developed at the Kimmel Cancer Center by Eisenberger and colleagues. Over the last decade, Eisenberger and colleagues have pioneered a new approach to chemotherapy, hitting prostate cancer increasingly harder and earlier-when it is much more vulnerable- and also using "smart" drugs to target specific molecular steps of cancer cell growth. The journey to this point has been hard, often discouraging, and yet Eisenberger has always believed that the secret code of cancer was crackable-that it is just a question of finding the right molecular key, or set of keys, and knowing the right lock, or bank of locks.

This shows that "prostate cancer is as sensitive to chemotherapy as other tumor types, such as breast cancer."

This 24-country trial is the largest study ever conducted in men with hormone-refractory prostate cancer-men with cancer that has spread after months or years of hormonal therapy. It was chaired by Eisenberger, along with physicians Ian Tannock, from Canada, and Ronald DeWit, from the Netherlands. In the landmark study, men were randomly assigned to receive a combination of prednisone and docetaxel (Taxotere) a drug in the taxol family, used to treat breast cancer- given weekly, or given every three weeks, or to receive a conventional drug regimen of mitoxantrone and prednisone. The men who showed the biggest improvement received prednisone and Taxotere every three weeks. Side effects, including a decrease in white blood cells, were moderate and reversible. "In general, treatment was well tolerated," says Eisenberger. "Men receiving Taxotere also were more likely to have a drop in their PSA level, better control of pain, and improvement in quality of life."

Because of the study's results, the Food and Drug Administration has approved the use of Taxotere for prostate cancer, says Eisenberger, who presented these findings at the plenary session of the American Society of Clinical Oncology. "This important study sets a new standard for chemotherapy in prostate cancer," he says. "It also indicates that prostate cancer is a tumor that is as sensitive to chemotherapy as other tumor types, such as breast cancer." Finally, he adds, the results point to further trials aimed at men with less advanced disease-for example, men after radical prostatectomy, whose pathology suggests that some cancer is still present, or men with no symptoms but rapid PSA doubling times (read related story). "Our clinical trials should now shift to using it even earlier, to delay or prevent the onset of cancer-related symptoms, and to further prolong survival."

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