Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25)
Mené sur 806 patientes atteintes d'un cancer de l'ovaire récemment diagnostiqué, cet essai randomisé évalue l'intérêt, du point de vue de la qualité de vie, de l'ajout de l'olaparib au bévacizumab en traitement d'entretien
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.
Journal of the National Cancer Institute , article en libre accès, 2026