ESMO 2017: Assessment of health-related quality of life in PROSELICA: A Phase 3 trial assessing cabazitaxel 20 mg/m2 vs 25 mg/m2 in post-docetaxel patients with metastatic castration-resistant prostate cancer (mCRPC)
PROSELICA was a phase III study at 172 centers worldwide, randomizing 1,200 patients with mCRPC progressing on docetaxel to either cabazitaxel 20 mg/m2 Q3W + prednisone 10 mg/day (n=598) vs cabazitaxel 25 mg/m2 Q3W + prednisone 10 mg/day (n=602). Functional Assessment of Cancer Therapy Prostate (FACT-P) was used to assess HRQL. The least square means of change in FACT-P total score from baseline was assessed via a mixed-effect model for repeated measurements and differences were compared for cabazitaxel 20 mg/m2 vs cabazitaxel 25 mg/m2 in patients receiving > 6 or ≤ 6 treatment cycles.
The overall change in FACT-P total scores from baseline to Cycle 10 was not significantly different for cabazitaxel 20 mg/m2 vs cabazitaxel 25 mg/m2 (cabazitaxel 20 mg/m2 n = 137: 0.02, 95%CI -2.57, 2.61]; cabazitaxel 25 mg/m2 n = 141: 1.33, 95%CI -1.26, 3.93; p = 0.369). For evaluable patients who received > 6 cycles, change in FACT-P total score from baseline to Cycle 10 favored cabazitaxel 25 mg/m2 but not cabazitaxel 20 mg/m2 (cabazitaxel 25 mg/m2 n = 140: 3.06, 95%CI 0.25, 5.86, p = 0.033; cabazitaxel 20 mg/m2 n = 137: 2.67, 95%CI -0.17, 5.51; p = 0.065). Difference in change was not significant for cabazitaxel 20 mg/m2 vs cabazitaxel 25 mg/m2 (-0.39, 95%CI: -3.66, 2.88; p = 0.816). For evaluable patients who received ≤ 6 cycles, change in FACT-P total score from baseline to Cycle 6 favored patients receiving cabazitaxel 25 mg/m2 (cabazitaxel 25 mg/m2 n = 49: -4.61, 95%CI: -8.27, -0.95; p = 0.014; cabazitaxel 20 mg/m2 n = 39: -6.58, 95%CI: -10.46, -2.69, p < 0.001) but the difference between the treatment arms was not significant (-1.96 [95%CI: -6.8, 2.87], p = 0.426). Increasing cycles, baseline ECOG performance score (0–1 vs ≥ 2) and receiving > 6 cycles significantly improved FACT-P total score change from baseline (p < 0.001). Difference in treatment dose (cabazitaxel 20 mg/m2 vs cabazitaxel 25 mg/m2) did not have a significant effect on FACT-P total score change from baseline (p = 0.354).
In summary, in the overall population, HRQL did not differ significantly from baseline to Cycle 10 for cabazitaxel 20 mg/m2 vs cabazitaxel 25 mg/m2. Additionally, there were no significant differences between the two treatment arms (cabazitaxel 20 mg/m2 vs cabazitaxel 25 mg/m2) in either subgroup (> 6 or ≤ 6 cycles). A significant change in HRQL from baseline to Cycle 10 was observed in patients who received > 6 cycles of cabazitaxel 25 mg/m2. These results suggest that cabazitaxel maintains HRQL in patients with mCRPC who have progressed on docetaxel.
Speaker: Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, United States of America
Co-Authors: A. Hardy-Bessard (Plérin, France) C. Kim (Seoul, Korea, Republic of) L. Géczi (Budapest, Hungary) D. Ford (Birmingham, United Kingdom) L. Mourey (Toulouse, France) J. Carles (Barcelona, Spain) P. Parente (Box Hill, Australia) A. Font (Badalona, Spain) G. Kacsó (Cluj-Napoca, Romania) G. Barnes (Cambridge, United States of America) H. Wang (Bridgewater, United States of America) W. Zhang (Bridgewater, United States of America) A. Ozatilgan (Cambridge, United States of America) J. De Bono (Sutton, United Kingdom)
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
References:
Eisenberger M, Hardy-Bessard AC, Kim CS, et al. Phase III study comparing a reduced dose of cabazitaxel (20 mg/m2) and the currently approved dose (25 mg/m2) in postdocetaxel patients with metastatic castration-resistant prostate cancer—PROSELICA. J Clin Oncol 2017 Aug 5 [Epub ahead of print].