An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer

Abstract

Background: Men with metastatic castration-resistant prostate cancer (mCRPC) are living longer, therefore optimizing health-related quality of life (HRQL), as well as survival outcomes, is important for optimal patient care. The aim of this study was to assess the HRQL in patients with mCRPC receiving docetaxel or cabazitaxel.

Patients and methods: PROSELICA (NCT01308580) assessed the non-inferiority of cabazitaxel 20 mg/m2 (C20) versus 25 mg/m2 (C25) in patients with mCRPC after docetaxel. FIRSTANA (NCT01308567) assessed the superiority of C25 or C20 versus docetaxel 75 mg/m2 (D75) in patients with chemotherapy-naive mCRPC. HRQL and pain were analyzed using protocol-defined, prospectively collected, Functional Assessment of Cancer Therapy-Prostate (FACT-P) and McGill-Melzack questionnaires. Analyses included definitive improvements in HRQL, maintained or improved HRQL, and HRQL over time.

Results: In total, 2131 patients were evaluable for HRQL across the two studies. In PROSELICA, 38.8% and 40.5% of patients receiving C20 and C25, respectively, had definitive FACT-P total score (TS) improvements. In FIRSTANA, 43.4%, 49.7%, and 44.9% of patients receiving D75, C20, and C25, respectively, had definitive FACT-P TS improvements. In both trials, definitive improvements started after cycle 1 and were maintained for the majority of subsequent treatment cycles. More than two-thirds of patients maintained or improved their FACT-P TS.

Conclusions: In PROSELICA and FIRSTANA, >40% of the 2131 evaluable patients with mCRPC had definitive FACT-P TS improvements; improvements occurred early and were maintained. More than 75% of patients maintained or improved their FACT-P TS.

Keywords: cabazitaxel; docetaxel; health-related quality of life; metastatic castration-resistant prostate cancer; patient-reported outcomes.

Conflict of interest statement

Disclosure AT: AstraZeneca (employment), Novartis, Sanofi, Astellas Pharma, Pfizer, Janssen, Ipsen (consulting or advisory role), Pfizer (research funding), and Novartis, Sanofi, Pfizer (travel, accommodations, expenses). KF: Janssen, Sanofi, Astellas Pharma (honoraria), Janssen Oncology, Bayer, Astellas Pharma, Sanofi, Orion Pharma GmbH, Curevac, AstraZeneca (consulting or advisory role), and Amgen, Janssen (travel, accommodations, expenses). OS: Bayer, Bellicum Pharmaceuticals, Johnson & Johnson, Medivation, Oncogenex, Sanofi, Tokai Pharmaceuticals, AstraZeneca (Inst), Progenics (Inst), Dendreon (consulting or advisory role), Bayer (Inst), Johnson & Johnson (Inst), Sanofi (Inst), Dendreon (Inst), Endocyte (Inst), Innocrin Pharma (Inst), Progenics (Inst) (research funding), Bayer, Johnson & Johnson, Medivation, Oncogenex, Sanofi, Tokai Pharmaceuticals, AstraZeneca, Progenics (travel, accommodations, expenses). SO: Sanofi, Janssen, Bayer, and Astellas (advisory board or board of directors). DB, KT, AO, and EMP: Sanofi employees. ME: VERU Inc. (board of directors). JB: Sanofi (honoraria), Sanofi, AstraZeneca, GlaxoSmithKline, Genentech, Roche, Merck (consulting or advisory role), AstraZeneca/MedImmune (speakers’ bureau), AstraZeneca/MedImmune (Inst), GlaxoSmithKline (Inst), Sanofi (Inst), Merck Sharp & Dohme (Inst), Genmab (Inst), Genentech (Inst) (research funding) and patent on abiraterone acetate with prednisone.

Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

Figures

Figure 1

Change in mean FACT-P TS from baseline at each cycle among the overall population for (A) PROSELICA and (B) FIRSTANA. Significant P values are shown by asterisks. C20/C25, cabazitaxel 20/25 mg/m2; D75, docetaxel 75 mg/m2; FACT-P TS, Functional Assessment of Cancer Therapy—Prostate total score; SE, standard error.

Figure 2

Change in mean FACT-P TS from baseline at each cycle in patients with a definitive improvement in FACT-P TS for (A) PROSELICA and (B) FIRSTANA. C20/C25, cabazitaxel 20/25 mg/m2; D75, docetaxel 75 mg/m2; FACT-P TS, Functional Assessment of Cancer Therapy—Prostate total score; SE, standard error.

Figure 3

Proportion of patients with a transient maintenance or improvement in FACT-P TS among all available patient HRQL assessments for the overall FACT-P population in (A) PROSELICA and (B) FIRSTANA and the subgroup of patients with a definitive improvement in FACT-P TS in (C) PROSELICA and (D) FIRSTANA. n = total evaluable patient HRQL assessments. A patient was considered to have a transient improvement in FACT-P TS if they had a ≥7-point change from baseline. A patient was considered to have a transient deterioration in FACT-P TS if they had a ≤-10% change from baseline. A patient was considered to have a transient maintenance in FACT-P TS if they did not meet the criteria for either transient improvement or transient deterioration. Transient FACT-P TS changes were determined for each evaluable HRQL assessment. C20/C25, cabazitaxel 20/25 mg/m2; D75, docetaxel 75 mg/m2; FACT-P TS, Functional Assessment of Cancer Therapy—Prostate total score; HRQL, health-related quality of life.