Impact of disease progression on health-related quality of life of advanced ovarian cancer patients - Pooled analysis from the PRIMA trial
- PMID: 35851489
- DOI: 10.1016/j.ygyno.2022.06.028
Impact of disease progression on health-related quality of life of advanced ovarian cancer patients - Pooled analysis from the PRIMA trial
Abstract
Objective: Progression-free survival (PFS) is an important early efficacy endpoint in ovarian cancer (OC) and its relevance to patients should be assessed. PRIMA, a phase III trial, assessed niraparib in patients with OC; this post hoc analysis examined the relationship between disease progression in OC and health-related quality of life (HRQoL).
Methods: The PRIMA trial randomized patients with advanced OC responsive to first-line platinum-based chemotherapy to once daily maintenance oral niraparib or placebo. This post hoc analysis evaluated the impact of disease progression on HRQoL by comparing HRQoL at the last visit pre-progression to end of treatment (EoT), and after 4, 8, 12, and 24 weeks. Assessments included the Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI), the European Quality of Life Five Dimension Five Level questionnaire (EQ-5D-5L) and EQ Visual Analogue Scale (EQ-VAS), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30), and the EORTC Quality of Life Questionnaire Ovarian Cancer module (EORTC-QLQ-OV28).
Results: This post hoc analysis included 733 patients. Mean FOSI, EQ-5D-5L, and EQ-VAS scores deteriorated from last visit pre-progression to EoT and remained low up to 24-week follow-up. Least squares mean changes from last visit pre-progression to EoT were -2.1 (95% confidence interval -2.4, -1.7) for FOSI, -4.6 (-5.6, -3.5) for the EQ-5D-5L index, and -7.9 (-9.6, -6.3) for EQ-VAS.
Conclusions: Disease progression negatively impacted HRQoL in patients with OC. PFS is clinically relevant, and prolonging PFS may preserve HRQoL.
Keywords: Health-related quality of life; Niraparib; Ovarian cancer; PRIMA; Progression-free survival.
Copyright © 2022. Published by Elsevier Inc.
Conflict of interest statement
Declaration of Competing Interest DMC reports personal fees from GSK; has received honoraria from Roche; been a consultant to Mateon Therapeutics and AstraZeneca, and her institution has received research grants from Genentech. Margarita RM reports grants from GSK, Clovis, and Pfizer; consulting fees from Merck & Co., Inc. and GSK; has received honoraria and travel support from AstraZeneca. FB has served on advisory boards from Merck, Eisai, Agenus, AstraZeneca, and GSK. WG reports personal fees from Tesaro. Mansoor RM reports receiving advisory board fees from AstraZeneca, Biocad, GSK, Karyopharm, Merck & Co., Inc., Roche, and Zailab; travel support from GSK and AstraZeneca; is a member of board of directors and holds shares in Karyopharm; received institutional research grants from Apexigen, AstraZeneca, Ultimovacs, and GSK. BP has received institutional grant support from Tesaro/GSK, AstraZeneca, Merck, Genentech/Roche, Celsion Corporation, Mersana Therapeutics, Inc., and Clovis Oncology, and advisory board compensation from Tesaro/GSK, AstraZeneca, Merck, Toray, Mersana Therapeutics, Inc., Elevar, Arquer Diagnostics, and Eisai. GM reports receiving travel grants from Merck & Co., Inc., GSK, AstraZeneca, and PharmaMar. DOM reports grants and personal fees from Clovis Oncology; has served on advisory boards for Agenus, AstraZeneca, Eisai, Genentech/Roche, ImmunoGen, Iovance Biotherapeutics, Janssen/Johnson & Johnson, Merck, Mersana, Myriad, Novartis Pharmaceuticals, Novocure, Regeneron Pharmaceuticals, Seagen, Tarveda, and Tesaro/GSK; has served on steering committees for Amgen; has served as a consultant to AbbVie, Agenus, Ambry, AstraZeneca, Eisai, Genentech/Roche, GOG Foundation, ImmunoGen, Iovance Biotherapeutics, Merck, Mersana, Novartis Pharmaceuticals, Novocure, Seagen, and Tesaro/GSK; and has received research support to his institution from AbbVie, Agenus, Ajinomoto, Amgen, Array BioPharma, AstraZeneca, Bristol-Myers Squibb, Cerulean Pharma, Eisai, EMD Serono, Ergomed Clinical Research, Genentech/Roche, Genmab, GOG Foundation, ImmunoGen, INC Research, inVentiv Health Clinical, Iovance Biotherapeutics, Janssen/Johnson & Johnson, Ludwig Institute for Cancer Research, Merck, Mersana, New Mexico Cancer Care Alliance, Novocure, PRA International, Regeneron Pharmaceuticals, Seagen, Serono, Stemcentrx, Tesaro/GSK, TRACON Pharmaceuticals, VentiRx, and Yale University. LW reports receiving fees from Genentech, GSK, AstraZeneca, Merck & Co., Inc., and Eisai. RLC reports grants and consulting fees from Agenus, Alkermes, Deciphera, GSK, OncoQuest Inc., Onxeo, Oncxerna, Regeneron, AstraZeneca, Clovis Oncology, Genelux, Genmab, Merck & Co., Inc., ImmunoGen Janssen, Roche/Genentech; served as a board member of VBL Therapeutics. DL reports receiving advisory board fees from AstraZeneca, Clovis Oncology, Genmab, Immunogen, and Amgen; grant support, paid to her institution, and consulting fees from PharmaMar, and grant support, paid to her institution, and advisory board fees from Merck. FMK and TW are employees of GSK. BJM reports receiving honoraria from Agenus, Akeso, Inc., Amgen, Aravive, AstraZeneca, Bayer, Clovis, Eisai, Elevar, EMD Merck, Genmab/Seagen, Gynecologic Oncology Group foundation, Gradalis, ImmunoGen, Karyopharm, Iovance, Macrogenics, Merck & Co., Inc., Mersana, Novartis, Novocure, Myriad, Pfizer, Puma, Regeneron, Roche/Genentech, Sorrento, Tesaro/GSK, US Oncology Research, VBL Therapeutics. AG-M reports receiving consulting fees, lecture fees, and/or travel support from Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, Immunogen, MacroGenics, Mersana, MSD, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, and Takeda. SH, DB, KB, TS, V-HS have no conflicts to disclose.
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