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Docetaxel (Taxotere) Demonstrates Efficacy for Treatment of Hormone-Refractory Prostate Cancer: Presented at ASCO

By M. M. Pennell

NEW ORLEANS, LA -- June 8, 2004 -- Results of 2 large randomized studies in men with hormone-refractory prostate cancer indicate that docetaxel (Taxotere)-based chemotherapy increased survival by about 20%.

The findings confirm for the first time that "prostate cancer is an appropriate target for chemotherapy," said Mario A. Eisenberger, MD, Professor of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, and lead investigator of one of the studies. Results of the two docetaxel trials were presented here June 7th during the plenary session at the American Society of Clinical Oncology 40th Annual Meeting.

Both studies combined Taxotere with another drug -- in 1 study the combination was Taxotere and estramustine, and in the other study it was combined with prednisone. Both studies compared Taxotere combos to standard chemotherapy of mitoxantrone and prednisone.

The findings have changed the standard of care for metastatic prostate cancer treatment, said Daniel P. Petrylack, MD, associate professor of medicine, Columbia University College of Physicians and Surgeons, New York, New York, and lead investigator in the Taxotere/estramustine study. "Docetaxel is now the standard of care, no question," he said.

Asked about the relatively small increase in average survival, he replied that while the average increase in survival was about 3 months, "I have patients that have survived for years on this regimen."

Dr. Petrylack's study enrolled 770 men with advanced prostate cancer that did not respond to hormone therapy, and randomized 334 to the docetaxel combination and 332 to standard therapy. The docetaxel-treated men survived an average of 18 months while men in the control group survived an average of 16 months. Time to progression of disease was twice as long in the docetaxel arm -- 6 months versus 3 months.

Dr. Eisenberger, who presented the second study, and colleagues enrolled men with histologically proven metastatic hormone-refractory prostate cancer. The researchers stratified the men according to pain and Karnofsky Performance Status and randomized into 3 treatment arms: 335 received daily oral prednisone 5 mg BID plus docetaxel 75 mg/m² every 3 weeks for 10 cycles; 334 received docetaxel 30 mg/m²/week for 5 of 6 weeks for 5 cycles; and 337 received mitoxantrone 12 mg/m² every 3 weeks for 10 cycles.

In this study the men given higher dose docetaxel had the best average survival rate -- 18.9 months -- compared with men on the lower-dose docetaxel regimen and those given standard therapy -- 17.4 months and 16.5 months, respectively.

But in all cases the survival advantage came at a cost -- more severe adverse effects such as nausea, anemia, and hair loss -- and when the dose was increased the adverse effects also increased.

Nonetheless, Dr. Eisenberger said he is enthusiastic about their results, noting that many of the men in the study "were able to go home, return to work, return to life" after undergoing treatment. "That's clinically significant," he said.


[Presentation title: SWOG 99-16: Randomized Phase III Trial of Docetaxel (D)/estramustine (E) Versus Mitoxantrone (M)/Prednisone (P) in Men With Androgen-Independent Prostate Cancer (AIPCA). Abstract 3. A Multicenter Phase III Comparison of Docetaxel (D) + Prednisone (P) and Mitoxantrone (MTZ) + P in Patients With Hormone-Refractory Prostate Cancer (HRPC). Abstract 4.]

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