Docetaxel Added to Hormone Therapy Benefits Survival in Metastatic Hormone-Sensitive Prostate Cancer

Barcelona, Spain—Results from a long-term follow-up of the STAMPEDE trial demonstrate a persistent clinically significant benefit in survival with docetaxel for patients with metastatic hormone-naïve prostate cancer, regardless of metastatic burden.

These results were presented at the ESMO 2019 Congress by Nicholas W. James, PhD, BSc, MB, BS, FRCP, FRCR, Queen Elizabeth Hospital, Birmingham, England.

The STAMPEDE trial previously reported that the use of upfront docetaxel lead to an improvement in overall survival for patients with metastatic hormone-naïve prostate cancer starting long-term androgen deprivation therapy.

A total of 1086 patients were enrolled in the trial and randomized in a 2:1 ratio to receive the standard of care therapy (n=724) or the standard of care plus docetaxel (n=362). Using retrospectively collected baseline staging scans, patients were categorized by metastatic disease burden; 362 low and 468 had high.

The median follow-up was 78.2 months. A total of 494 deaths were reported in the standard of care arm; 41% more than previously reported. Docetaxel showed a strong benefit over standard of care for overall survival (OS; HR = 0.81, 95% CI 0.69–0.95, P=0.009) and had no differences observed between metastatic burden subgroups.

Another analysis showed benefit for docetaxel over the standard of care in failure-free survival (HR=0.66, 95% CI 0.57–0.76, P<0.001) and progression-free survival (HR=0.69, 95% CI 0.59–0.81, P<0.001) with no differences observed between metastatic burden subgroups.

Additionally, docetaxel was not associated with greater late toxicity compared with standard of care. After 1 year, grade 3-5 toxicity was reported in 28% of patients who received standard of care and 27% of patients who received docetaxel.

“This analysis does not support the presence of a volume effect on docetaxel effect in men with newly diagnosed metastatic prostate cancer. Metastatic burden is, however, strongly prognostic, as you would expect; which is consistent with all the other trials,” Dr James concluded.—Janelle Bradley

Clarke NW, Ali A, et al. Docetaxel for hormone-naïve prostate cancer: results from long-term follow-up of metastatic (M1) patients in the STAMPEDE randomised trial (NCT00268476) and sub-group analysis by metastatic burden. Presented at: ESMO 2019 Congress; September 27-October 1, 2019; Barcelona, Spain. Abstract 844O