Docetaxel clears another hurdle in high-risk prostate Ca trials

September 7, 2005

Initial findings from a continuing phase II multicenter study of docetaxel (Taxotere) as adjuvant therapy in radical prostatectomy patients at high risk of recurrence have shown that the drug is well tolerated, with reversible side effects.

Initial findings from a continuing phase II multicenter study of docetaxel (Taxotere) as adjuvant therapy in radical prostatectomy patients at high risk of recurrence have shown that the drug is well tolerated, with reversible side effects.

"The bottom line is that docetaxel prolongs survival in metastatic disease, but with only a 2-month survival advantage," said co-author Adam S. Kibel, MD, of Washington University Medical Center, St. Louis. "The goal now is to see if earlier treatment can provide a more robust survival advantage.

In this study, 77 patients who had undergone radical prostatectomy for prostate cancer and who were estimated to have a 50% or greater risk of recurrence within 3 years were given six cycles of intravenous docetaxel at 35 mg/m2 on days 1, 8, and 15 of a 28-day cycle beginning 4 to 12 weeks after surgery. All patients completed treatment. The only grade IV toxicity was hyperglycemia in 2.6% of patients. Grade III hyperglycemia occurred in 7.8% of patients and 5% reported grade III dyspnea. One patient died of causes unrelated to the therapy.

"We have proven that the toxicity is relatively low; however, even this level of toxicity can only be justified if there is a survival advantage. This is not a treatment that I would recommend for routine care—at least not at this stage," Dr. Kibel said at the AUA annual meeting.

Docetaxel's effects on survival will not be known until the phase II trial concludes and the results can be compared with 77 matching control subjects.