Docetaxel may prolong prostate cancer survival in patients with metastasis

Docetaxel added to the start of hormone therapy for metastatic prostate cancer may prolong survival compared to patients who received hormone therapy alone, according to early results from a trial.

The National Institutes of Health released early results from a randomized controlled clinical trial on Dec. 5. The independent data and safety monitoring committee overseeing the trial recommended that the study results become public after a planned interim analysis showed a prolongation in overall survival. Full details from the early analysis will be presented at a scientific meeting in 2014 and in a peer-reviewed publication.

Researchers enrolled 790 men with metastatic prostate cancer between July 2006 and November 2012. All patients started treatment with androgen deprivation therapy (ADT) and then received either ADT alone or ADT with docetaxel every 3 weeks for 18 weeks.

There was a significant improvement in the overall survival among patients who had received docetaxel with ADT (69%) compared to the ADT alone (52.5%). About two-thirds of patients in the study had metastasized disease that had spread to major organs, had resulted in 4 or more bone lesions, or both. This group accounted for most of the benefit in the overall survival (3-year survival rates of 63.4% on docetaxel and ADT vs. 43.9% on ADT alone).

The researchers noted that while docetaxel is approved in the U.S., its toxicity means that use should be restricted to patients with high-extent metastatic prostate cancer, the group of patients who experienced the most benefit in the current analysis.

“The results of this study are practice-changing,” said the lead investigator in a press release. “We have strong scientific evidence that patients with the most advanced metastatic prostate cancer benefit from the early addition of docetaxel to ADT and not waiting until the cancer has progressed on hormonal therapy. The findings of this study are important both for improving the clinical care we deliver now and in designing new clinical trials as we strive to further improve the lives of men with metastatic prostate cancer.”