Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25)

BACKGROUND: We analyzed health-related quality of life (HRQoL) and time until definitive HRQoL deterioration (TUDD) for patients with newly diagnosed advanced ovarian cancer receiving olaparib plus bevacizumab or placebo plus bevacizumab in PAOLA-1. METHODS: HRQoL and TUDD, prespecified secondary endpoints, were assessed by EORTC Core Quality of Life Questionnaire (QLQ-C30) and Ovarian Cancer module (QLQ-OV28) at baseline and then every 12 weeks for 2 years. HRQoL and TUDD by homologous recombination deficiency (HRD) status and effect of progression on HRQoL were post hoc analyses. RESULTS: 806 patients were randomized (olaparib plus bevacizumab n = 537; placebo plus bevacizumab n = 269). There were no clinically meaningful between-group differences in adjusted mean global change from baseline in QLQ-C30 or QLQ-OV28 domains overall (between-group difference in QLQ-C30 Global Heath Status (GHS) score [95% CI] 1.65 [-0.27, 3.56]) or in the HRD-positive subgroup (1.23 [-1.25, 3.71]). TUDD estimates of QLQ-C30 GHS scores did not differ between treatment arms in the modified intention-to-treat population (hazard ratio [HR]=0.88; 95% CI = 0.72, 1.07) and favored olaparib plus bevacizumab vs placebo plus bevacizumab in the HRD-positive subgroup (HR = 0.70; 95% CI = 0.52, 0.93). Analyses of patients (103/465 [22.2%]) following disease progression showed clinically meaningful deterioration in QLQ-C30 emotional and social scores. CONCLUSION: Adding maintenance olaparib to bevacizumab showed no clinically meaningful detrimental effect on global HRQoL either overall or in the HRD-positive subgroup. ClinicalTrials.gov ID: NCT02477644.

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Journal
JNCI Journal of the National Cancer Institute
Published
2026-04-21
DOI
https://doi.org/10.1093/jnci/djag122
Primary Topic
PARP inhibition in cancer therapy
Type
article
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article

Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25)

Amélie Anota, Alexander Burges, Beyhan Ataseven, Carmela Pisano et al.
JNCI Journal of the National Cancer Institute
PARP inhibition in cancer therapy
article

Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25)

Amélie Anota, Alexander Burges, Beyhan Ataseven, Carmela Pisano, Peter Vuylsteke, Irina Tsibulak, Paul Buderath, Claire Cropet, M. Lapresa, Sylvie Chabaud, Frank Priou, Patrick Bouchaert, Cécile Guillemet, Núria Laínez, Lauriane Eberst, Edgar Petru, Eugenia Ortega, Gabriella Parma, G Scambia, Mansoor Raza Mirza, Eric Raymond, Domenica Lorusso, Ignace Vergote, Sandro Pignata, Isabel Palacio, Ana Herrero, Hiroaki Kobayashi, Isabelle Ray-Coquard, Jean-Emmanuel Kurtz, Florence Joly, Johanna Mäenpää, Eric Pujade-Lauraine, Kan Yonemori, Philipp Harter
article en

Abstract

BACKGROUND: We analyzed health-related quality of life (HRQoL) and time until definitive HRQoL deterioration (TUDD) for patients with newly diagnosed advanced ovarian cancer receiving olaparib plus bevacizumab or placebo plus bevacizumab in PAOLA-1. METHODS: HRQoL and TUDD, prespecified secondary endpoints, were assessed by EORTC Core Quality of Life Questionnaire (QLQ-C30) and Ovarian Cancer module (QLQ-OV28) at baseline and then every 12 weeks for 2 years. HRQoL and TUDD by homologous recombination deficiency (HRD) status and effect of progression on HRQoL were post hoc analyses. RESULTS: 806 patients were randomized (olaparib plus bevacizumab n = 537; placebo plus bevacizumab n = 269). There were no clinically meaningful between-group differences in adjusted mean global change from baseline in QLQ-C30 or QLQ-OV28 domains overall (between-group difference in QLQ-C30 Global Heath Status (GHS) score [95% CI] 1.65 [-0.27, 3.56]) or in the HRD-positive subgroup (1.23 [-1.25, 3.71]). TUDD estimates of QLQ-C30 GHS scores did not differ between treatment arms in the modified intention-to-treat population (hazard ratio [HR]=0.88; 95% CI = 0.72, 1.07) and favored olaparib plus bevacizumab vs placebo plus bevacizumab in the HRD-positive subgroup (HR = 0.70; 95% CI = 0.52, 0.93). Analyses of patients (103/465 [22.2%]) following disease progression showed clinically meaningful deterioration in QLQ-C30 emotional and social scores. CONCLUSION: Adding maintenance olaparib to bevacizumab showed no clinically meaningful detrimental effect on global HRQoL either overall or in the HRD-positive subgroup. ClinicalTrials.gov ID: NCT02477644.

JNCI Journal of the National Cancer Institute
Université Claude Bernard Lyon 1 (FR), Università Cattolica del Sacro Cuore (IT), Gynecologic Oncology Group (US), European Union (BE), Institut national de recherche en sciences et technologies du numérique (FR), Humanitas University (IT), Innsbruck Medical University (AT), University of Namur (BE), Inserm (FR), Mario Negri Institute for Pharmacological Research (IT), Medical University of Graz (AT), Agostino Gemelli University Polyclinic (IT), Copenhagen University Hospital (DK), LMU Klinikum (DE), Nordic Society of Gynecologic Oncology (DK), Mitsubishi Heavy Industries (Italy) (IT), National Cancer Center (US), Institut de Cancérologie Strasbourg (FR), The European Academy of Gynaecological Surgery (BE), CHU Dinant Godinne UCL Namur (BE), Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe (DE), Complejo Hospitalario de Navarra (ES), Centre François Baclesse (LU), Centre Léon Bérard (FR), West Cancer Center (US), Centre Hospitalier Universitaire de Poitiers (FR), Hospital Universitario Miguel Servet (ES), Arbeitsgemeinschaft Urologische Onkologie (DE), Kagoshima University Hospital (JP), Arbeitsgemeinschaft Dermatologische Onkologie (DE), Essen University Hospital (DE), Tampere University Hospital (FI), Tampere University (FI), Hospital Universitario Central de Asturias (ES), Arcagy Gineco (FR), Hôpital Paris Saint-Joseph (FR), Laboratoire National Henri Becquerel (FR), Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT), Tumori Foundation (US), Kliniken Essen-Mitte (DE), Centre Hospitalier Départemental Vendée (FR), Spanish Ovarian Cancer Research Group (ES), Tokyo National Hospital (JP), La Roche College (US), European Institute of Oncology (IT), Ludwig-Maximilians-Universität München (DE), Universidad de Navarra (ES), Université de Caen Normandie (FR)
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PARP inhibition in cancer therapy
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