These latest results of STAMPEDE lend further support to the early use of chemotherapy in men with advanced prostate cancer. They confirm the CHAARTED trial results reported last year by Christopher J. Sweeney, MBBS, which were practice-changing. Men with newly diagnosed metastatic hormone-sensitive advanced prostate cancer should be offered docetaxel in addition to hormone therapy upfront; in nonmetastatic patients, further follow-up is needed before early chemotherapy is routinely offered, since failure-free survival but not overall survival is improved,” stated Daniel Petrylak, MD, Professor of Medicine, Director, Genitourinary Oncology Research Program, and Co-Director, Signal Transduction Program at Yale Comprehensive Cancer Center in New Haven.

The practice of offering chemotherapy along with hormone therapy to high-risk hormone-sensitive patients is becoming more widely adopted in clinical practice, and these results should help further that process.

The results of the STAMPEDE trial provide level 1 evidence that the addition of docetaxel to standard androgen-deprivation therapy prolongs life relative to androgen-deprivation therapy alone in a population of men with newly diagnosed prostate cancer, which includes those with high-risk, localized, regionally metastatic, and more distant metastatic disease. ­STAMPEDE also shows that the addition of zoledronic acid to effective antitumor therapy, does not prolong life.

Incorporating a continuously accruing control arm enabled three “experimental” arms to be evaluated at the same time, avoiding the need to wait for a single trial to fully accrue, mature, and report before starting the process of designing a new trial. The evaluation of several other “experimental” arms, some incorporating the recently approved life-prolonging agents, is ongoing.

“The missing piece is the role of chemotherapy earlier in the course of disease. The TAX 3503 study evaluated whether docetaxel plus hormones vs hormones alone would delay metastasis and delay the need to restart hormones for nonmetastatic patients in the salvage setting following a rise in prostate-specific antigen level after radical prostatectomy,” Dr. Petrylak said. The PUNCH trial is now completing accrual, and that study is looking at docetaxel plus radical prostatectomy vs radical prostatectomy alone in high-risk localized prostate cancer. Long-term follow-up of both these trials is awaited. ■

Disclosure: Dr. Petrylak has received honoraria from Sanofi-Aventis, Johnson & Johnson, Bayer, and  Astellas.