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Poster display session

4522 - Assessment of health-related quality of life (HRQL) in PROSELICA: A Phase 3 trial assessing cabazitaxel 20 mg/m2 (C20) vs 25 mg/m2 (C25) in post-docetaxel (D) patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)


10 Sep 2017


Poster display session


Mario Eisenberger


Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370


M. Eisenberger1, A. Hardy-Bessard2, C.S. Kim3, L. Géczi4, D. Ford5, L. Mourey6, J. Carles7, P. Parente8, A. Font9, G. Kacsó10, G. Barnes11, H. Wang12, W. Zhang12, A. Ozatilgan13, J. de Bono14

Author affiliations

  • 1 Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 21231-1000 - Baltimore/US
  • 2 Cario, Centre Armoricain d'Oncologie, Plérin/FR
  • 3 Department Of Urology, Asan Medical Center, Seoul/KR
  • 4 Department Of Oncological Internal Medicine, National Institute of Oncology, Budapest/HU
  • 5 Cancer Centre Queen Elizabeth Hospital, City Hospital, Birmingham/GB
  • 6 Iuct-o, Institut Claudius Regaud, Toulouse/FR
  • 7 Vall D’hebron Institute Of Oncology, Vall d’Hebron University Hospital, Barcelona/ES
  • 8 Eastern Health Clinical School, Monash Univeristy, Box Hill/AU
  • 9 Institut Català D’oncologia, Hospital Universitari Germans Trias i Pujol, Badalona/ES
  • 10 Amethyst Cluj, Iuliu Hatieganu Medical University, Cluj-Napoca/RO
  • 11 Department Of Biostatistics, Sanofi, Cambridge/US
  • 12 Department Of Biostatistics, Sanofi, Bridgewater/US
  • 13 Medical Affairs, Sanofi, Cambridge/US
  • 14 Institute Of Cancer Research, Royal Marsden NHS Foundation Trust, Sutton/GB


Abstract 4522


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).


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.


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  6 cycles significantly improved FACT-P TS change from BL (p 


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


Legal entity responsible for the study





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.

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