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Docetaxel (D) plus high-dose calcitriol versus D plus prednisone (P) for patients (Pts) with progressive castration-resistant prostate cancer (CRPC): Results from the phase III ASCENT 2 trial. Authors: Scher HI et al, ASCO 2010 Abstract: 4509 Reviewed by: Dr. Lori Wood
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Docetaxel (D) plus high-dose calcitriol versus D plus prednisone (P) for patients (Pts) with progressive castration-resistant prostate cancer (CRPC): Results from the phase III ASCENT 2 trial Authors: Scher HI et al, ASCO 2010 Abstract: 4509 Reviewed by: Dr. Lori Wood Date posted: Jun 18 2010
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DN101 = high-dose calcitriol ASCENT1 – randomized phase II trial Docetaxel qwk vs. Docetaxel qwk + DN101 Primary endpoint – PSA decline (49% vs. 58%; p=0.16) Secondary endpoint – survival (16.4m vs. 24.5m; p=0.07) Overall survival was not the primary endpoint, however given the difference seen, a randomized phase III study was planned (ASCENT2) TAX327 data was available by this time so the control arm in ASCENT2 became Docetaxel q3wks There was discussion about a 3 arm study with however, due to numbers and logistics this was not undertaken STUDY RATIONALE
STUDY DESIGN Treatment A: Docetaxel 75 mg/m2 q3 wks Prednisone N=476 R Treatment B: Docetaxel 36 mg/m2weekly DN101 45 µg p.o. qwk N=477 • CRPC • First-line therapy • Primary outcome: • - duration of survival • Statistics: • - HR=0.78
STUDY COMMENTARY • High-dose calcitriol did not improve overall survival in the first line setting of men with CRPC • Weekly Docetaxel plus DN101in fact had a worse survival compared to Docetaxel alone q3wks • The difference most likely due to weekly Docetaxel and not due to addition of DN101 given that the overall survival was very similar to the weekly Docetaxel arm in the TAX327 study
BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Docetaxel 75 mg/m2 q3wks remains standard of care