Docetaxel (Taxotere) extends life in advanced prostate cancer patients

The results of two recent Phase III clinical trials indicate that docetaxel (Taxotere) extends life in advanced prostate cancer patients who are resistant to hormone therapy, supporting the Food and Drug Administration’s approval of docetaxel injection, in combination with prednisone, for the treatment of patients with advanced metastatic prostate cancer.

The results of the trials were presented at the annual meeting of the American Society of Clinical Oncology in New Orleans on June 7. One three-year international trial found that docetaxel decreases the chance of dying by 24% in these patients. Researchers randomly assigned 1,006 hormone-resistant prostate cancer patients to receive intravenous docetaxel (every three weeks or weekly) or the current standard chemotherapy drug, mitoxantrone. Patients receiving docetaxel every three weeks survived 2.4 months longer on average than those receiving mitoxantrone or docetaxel weekly.

"The study’s statistics are very robust. Two months may not sound like much time to most people, but the study shows that prostate cancer responds to docetaxel and this opens up the door to explore more options," says Mario Eisenberger, MD, co-chair of the study and the R. Dale Hughes Professor of Oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore. The study results also show significant improvements in pain relief and lowering prostate specific antigen blood levels. Aventis Pharmaceuticals, maker of docetaxel, funded the study.

Results echoed in second study

Researchers in the second study randomized 770 patients to one of two treatment arms: docetaxel 60 mg/m2 every three weeks and estramustine 280 mg three times daily for five days or mitoxantrone 12 mg/m2 every three weeks and prednisone 5 mg twice daily.

The researchers found that the docetaxel-based regimen reduced patients’ risk of death by 20%. The trial investigators also reported a 27% increase in disease progression-free survival and a 55% increase in objective response rate in the patients taking docetaxel. In addition, the majority of these patients had a PSA decline of more than 50%.

"These results demonstrate the first major therapeutic advance in prostate cancer and offer hope for millions of men worldwide," says Daniel P. Petrylak, MD, associate professor of medicine at Columbia University College of Physicians & Surgeons in New York City and director of the Genitourinary Oncology Program at New York-Presbyterian Hospital.

Both sets of researchers say that docetaxel had a manageable safety profile.