Administering 6 cycles of docetaxel at the beginning of androgen-deprivation therapy (ADT) to patients with metastatic, hormone-sensitive prostate cancer (mHSPC) resulted in a significantly longer overall survival (OS) than ADT alone.
The New England Journal of Medicine.
The study authors chose an intention-to-treat analysis. For each amendment, researchers adjusted the sample size so that the study would have 80% power to discover a 33.3% difference in median OS between the ADT plus docetaxel group and ADT-alone group, with the use of a stratified log-rank examination at a one-sided alpha level of 2.5%.
The trial included a total of 790 patients, 397 for the combination group and 393 for the ADT-alone group, with a median age of 63 years. Men with mHSPC received either ADT plus docetaxel at a dose of 75 mg/m2of body-surface area every 3 weeks for 6 cycles, or ADT alone.
Median OS was 13.6 months longer with the combination therapy compared with ADT alone, after a median follow-up of 28.9 months (57.6 months vs 44.0 months; combination group HR for death, 0.61; 95% Cl, 0.47-0.80;P<.001).
Median time to biochemical, symptomatic, or radiographic progression was 20.2 months for the ADT plus docetaxel group compared with 11.7 months in the ADT-alone group (HR, 0.61; 95% Cl, 0.51- 0.72;P<.001). A prostate-specific antigen level of less than 0.2 ng/mL at 12 months was 27.7% for the combination group and 16.8% for the ADT-alone group (P<.001).
For the combination group, the rate of grade 3 or 4 febrile neutropenia was 6.2%, 2.3% for grade 3 or 4 infection with neutropenia, and 0.5% for grade 3 sensory neuropathy and grade 3 motor neuropathy.
Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer.N Engl J Med. 2015; 373(8):737-746.