Assessment of health-related quality of life (HRQL) in PROSELICA: A Phase 3 trial assessing cabazitaxel 20 mg/m2 (C20) vs 25mg/m2 (C25) in post-docetaxel (D) patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)

Background: PROSELICA (NCT01308580) assessed effect of C20 vs C25 on overall survival in a non-inferiority study of pts with mCRPC. Primary analyses included assessment of HRQL in the overall population. Post-hoc subgroup analyses investigated changes in HRQL in pts receiving C20 vs C25 according to median treatment cycles received (6). Methods: Functional Assessment of Cancer Therapy Prostate (FACT-P) was used to assess HRQL. The least square means of change in FACT-P total score (TS) from baseline (BL) was assessed via a mixed-effect model for repeated measurements and differences were compared for C20 vs C25 in pts receiving > 6 or ≤ 6 treatment cycles. Results: Overall change in FACT-P TS from BL to Cycle 10 was not significantly different for C20 vs C25 (C20 n = 137: 0.02 [95% confidence interval [CI] -2.57, 2.61]; C25 n = 141: 1.33 [95% CI -1.26, 3.93]; p = 0.369). For evaluable pts who received > 6 cycles, change in FACT-P TS from BL to Cycle 10 favored C25 but not C20 (C25 n = 140: 3.06 [95% CI 0.25, 5.86], p = 0.033; C20 n = 137: 2.67 [95% CI -0.17, 5.51], p = 0.065). Difference in change was not significant for C20 vs C25 (-0.39 [95% CI: -3.66, 2.88], p = 0.816). For evaluable pts who received ≤ 6 cycles, change in FACT-P TS from BL to Cycle 6 favored pts receiving C25 (C25 n = 49: -4.61 [95% CI: -8.27, -0.95], p = 0.014; C20 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, BL ECOG performance score (0–1 vs ≥ 2) and receiving > 6 cycles significantly improved FACT-P TS change from BL (p < 0.001). Difference in treatment dose (C20 vs C25) did not have a significant effect on FACT-P TS change from BL (p = 0.354). Conclusions: In the overall population, HRQL did not differ significantly from BL to Cycle 10 for C20 vs C25. Additionally, there were no significant differences between the two treatment arms (C20 vs C25) in either subgroup (> 6 or ≤ 6 cycles). A significant change in HRQL from BL to Cycle 10 was observed in patients who received > 6 cycles of C25. Funding: Sanofi. Clinical trial identification: NCT01308580 Legal entity responsible for the study: Sanofi Funding: Sanofi Disclosure: D. Ford: Honoraria from Astellas, Janssen and Sanofi. L. Mourey: Personal fees and non-financial support from Sanofi, Astellas, Janssen, Pfizer and Novartis, personal fees from Ipsen and Sandoz, non-financial support from Roche, grant from GSK. J. Carles: Consultancy role for Johnson & Johnson, Bayer, Astellas, BMS, Pfizer and Sanofi. G. Kacsó: Advisory boards and/or conferences for Amgen, Astellas, AstraZeneca, Bayer, Ipsen-Beaufour, Janssen, Novartis, Pfizer and Sanofi, clinical trials for Astellas, Ipsen-Beaufour, Janssen and Sanofi. G. Barnes: Consultant for Sanofi. H. Wang: Employee of Sanofi and own Sanofi stock. Previously employed by Merck & Co. W. Zhang: Consultant for Sanofi. A. Ozatilgan: Employee of Sanofi. J. de Bono: Grants and personal fees from Sanofi, AstraZeneca, Genentech and Genmab, personal fees from Pfizer, Merck, Merck Serono, Daiichi-Sankyo, grant from Taiho. All other authors have declared no conflicts of interest.