This phase III trial randomized 31 newly diagnosed mHSPC patients to receive cabazitaxel 25 mg/m2 every 3 weeks for 10 cycles, followed by ADT (immediately after last cabazitaxel cycle, n=15) versus ADT alone (n=16). The primary end-point was OS and the secondary end-point was progression free survival (PFS). The study planned to include 400 patients but was closed prematurely due to low inclusion rate. Of the cabazitaxel treated patients, 66.8% received six cycles or more and 46.7% completed all 10 cycles. Over a median follow up of 31 months, the median OS was 32.5 months with cabazitaxel followed by ADT and 29.5 months with ADT alone (HR 1.43, 95%CI 0.38-5.38). Median PFS was significantly longer in cabazitaxel treated patients (29 vs 12 months; HR 3.96, 95%CI 1.49-10.49). The most common grade ≥ 3 toxicities were neutropenia (66%).
In conclusion, the authors note that results from this prematurely terminated trial suggest that cabazitaxel followed by ADT is effective in newly diagnosed mHSPC and shows a manageable toxicity. If possible, these results will have to be validated in larger randomized trials.
Speaker: Ove Andrén, Orebro University, Orebro, Sweden
Co-Authors: A. Widmark (Umea, Sweden) A. Falt (Orebro, Sweden) E. Ulvskog (Orebro, Sweden) S. Davidsson (Orebro, Sweden) C. Thellenberg Karlsson (Umea, Sweden) M. Hjalm-Eriksson (Stockholm, Sweden)
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, Twitter: @zklaassen_md at the European Society for Medical Oncology Annual Congress - September 8 - 12, 2017 - Madrid, Spain
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