5132 - Post hoc responder analysis of health‐related quality of life (HRQL) in patients with metastatic castration‐resistant prostate cancer (mCRPC) receiving cabazitaxel in the Phase III PROSELICA and FIRSTANA trials

Background

PROSELICA (NCT01308580) assessed the non-inferiority of cabazitaxel 20 mg/m² (C20) vs 25 mg/m² (C25) in patients (pts) with mCRPC post docetaxel, while FIRSTANA (NCT01308567) investigated whether C20 and C25 were superior to docetaxel 75 mg/m² (D75) in chemotherapy-naive mCRPC. This analysis evaluated the impact of cabazitaxel on HRQL in both trials.

Methods

Alongside pain and analgesic score, HRQL was assessed using the Functional Assessment of Cancer Therapy Prostate (FACT-P) questionnaire. The analysis focused on FACT-P (clinically meaningful improvement or deterioration of total score [TS]) among responders.

Results

Pt baseline characteristics are shown in the table. In PROSELICA, 57.2% and 59.4% of pts receiving C20 and C25 had FACT-P TS improvements; in FIRSTANA, 63.5%, 62.3% and 57.7% of pts receiving C20, C25 and D75 had FACT-P TS improvements. In FACT-P responders, FACT-P TS improvements occurred as early as Cycle (C) 1 (mean change from baseline: PROSELICA C20 10.4, n = 264; C25 10.6, n = 266; FIRSTANA C20 11.7, n = 206; C25 11.7, n = 202; D75 9.0, n = 195); these were largely maintained. For pts with a pain response in PROSELICA, FACT-P TS improvements occurred as early as C1 (C20 6.8, n = 71; C25 11.1, n = 81) and were maintained until C8 (C20 10.6, n = 43; C25 9.6, n = 44). In FIRSTANA, FACT-P TS improvements in pts with a pain response were seen as early as C1 or C2 (C1: C20 15.5, n = 41; C25 12.5, n = 41; D75, 7.9, n = 32) and maintained until C9 (C20 9.0, n = 27; C25 10.5, n = 26; D75 16.4, n = 20). In pts with a tumor or PSA response, HRQL was maintained for all treatment arms in both studies. Additional results for clinical responder subgroups and FACT-P subscales will be presented.Table: 812P

C20, cabazitaxel 20 mg/m²; C25, cabazitaxel 25 mg/m²; D75, docetaxel 75 mg/m²; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FACT-P TS, Functional Assessment of Cancer Therapy Prostate Total Score; PSA, prostate-specific antigen; SD, standard deviation.

Conclusions

More than half of the pts experienced HRQL improvements, which were maintained. Pts with a pain response experienced HRQL improvements. Funding: Sanofi.

Clinical trial identification

PROSELICA: NCT01308580. FIRSTANA: NCT01308567.

Legal entity responsible for the study

Sanofi.

Funding

Sanofi.

Editorial Acknowledgement

Editorial assistance was provided by Mark Cockerill of MediTech Media Ltd, funded by Sanofi.

Disclosure

A. Thiery Vuillemin: Employee: AstraZeneca; Consultancy, advisory role: Novartis, Sanofi, Astellas, Pfizer, Janssen, Ipsen, Pfizer; Research funding: Pfizer; Travel, accommodation and expenses: Novartis, Sanofi, Pfizer. K. Fizazi: Honoraria: Janssen, Sanofi, Astellas, Takeda; Consultancy, Advisory role: Janssen Oncology, Bayer, Astellas, Sanofi, Orion Pharma GmbH, Curevac, AstraZeneca, ESSA, Genentech; Travel, accommodation and expenses: Amgen. O. Sartor: Advisor: Bellicum Pharmaceuticals, Dendreon; Advisor and expenses: Bayer, Johnson & Johnson, Medivation, Oncogenex, Sanofi, Tokai Pharmaceuticals, AstraZeneca, Progenics; Institute: funding: Bayer, Johnson & Johnson, Sanofi, Dendreon, Endocyte, Innocrin Pharma, Progenics. S. Oudard: Consultancy, advisory role, honoraria, expenses: Sanofi, Astellas, Janssen, Ipson; Research funding: Sanofi; Speakers bureau: Sanofi, Janssen. D. Bury: Contractor: Sanofi; Employee: Artech. S. Guillonneau, A. Ozatilgan: Employee: Sanofi. M. Eisenberger: Honoraria, Consultancy, Advisory role: Sanofi, Pfizer, Astellas; Research: Sanofi; Expenses: Sanofi, Pfizer. J.S. de Bono: Honoraria: Sanofi; Advisor: Sanofi, AstraZeneca, GSK, Genentech, Roche, Merck; Speakers' bureau: AstraZeneca/MedImmune; Research funding (institute): AstraZeneca/MedImmune, GSK, Sanofi, Merck Sharp & Dohme, Genmab, Genentech; Patent on abiraterone acetate with prednisone.