CHAARTED and GETUG-15 Studies
At the 2014 ASCO Annual Meeting, the phase III E3805 (CHAARTED) trial presented at the Plenary Session showed that the addition of docetaxel to standard hormone therapy extended survival by more than 1 year in men with newly diagnosed, hormone-sensitive prostate cancer.1 The survival benefit of docetaxel was mainly driven by men with extensive metastatic disease.
Lead author Christopher J. Sweeney, MBBS, of the Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute in Boston, said: “The data from STAMPEDE and CHAARTED identify a strategy that prolongs survival in newly diagnosed metastatic prostate cancer. The benefit is substantial and warrants this being adopted as a new standard treatment for men who have high-extent disease and are able to tolerate chemotherapy.”
The study randomized 790 men to androgen-deprivation therapy alone vs androgen deprivation plus six cycles of docetaxel. Median overall survival was significantly superior in the docetaxel-containing arm: 57.6 months vs 44 months (P = .0003), for a 39% reduction in the risk of death. In men with extensive disease, median overall survival was 49.2 months for the combination vs 32.2 months for androgen deprivation alone (P < .0006), for a 40% reduction in the risk of death.
At the 2015 Genitourinary Cancers Symposium, lead author Gwenaelle Gravis, MD, reported an updated overall survival analysis of GETUG-15.2 The updated analysis, with a follow-up of 82.9 months, showed a median overall survival of 60.9 months for androgen-deprivation therapy plus docetaxel vs 46.5 months for androgen-deprivation therapy alone, which was not statistically significant. ■
Disclosure: Dr. Gravis is on the board of and receives travel support from Sanofi-Aventis. Dr. Sweeney is a compensated consultant for Astellas, AstraZeneca, Bayer, BIND Therapeutics, Genentech, Janssen, and Sanofi.
1. Sweeney C, et al: 2014 ASCO Annual Meeting. Abstract LBA2.
2. Gravis G, et al: 2015 ASCO Annual Meeting. Abstract 140.
Results from the STAMPEDE trial showed that the addition of docetaxel to standard hormone therapy improved overall survival by a median of 10 months over hormone therapy alone in men with newly diagnosed, advanced, hormone therapy–naive prostate cancer.1 The study also showed that zoledronic acid...
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...