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

Abstract Background We analyzed health-related quality of life (HRQoL) and time until definitive HRQoL deterioration for patients with newly diagnosed advanced ovarian cancer receiving olaparib plus bevacizumab or placebo plus bevacizumab in PAOLA-1. Methods Health-related QoL and time until definitive HRQoL deterioration, prespecified secondary endpoints, were assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) and Ovarian Cancer module (QLQ-OV28) at baseline and then every 12 weeks for 2 years. Health-related QoL and time until definitive HRQoL deterioration by homologous recombination deficiency status and effect of progression on HRQoL were post hoc analyses. Results A total of 806 patients were randomly assigned (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 = 1.65, 95% CI = −0.27 to 3.56) or in the homologous recombination deficiency–positive subgroup (between-group difference in QLQ-C30 GHS = 1.23, 95% CI = −1.25 to 3.71). Time until definitive HRQoL deterioration 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 to 1.07) and favored olaparib plus bevacizumab vs placebo plus bevacizumab in the homologous recombination deficiency–positive subgroup (HR = 0.70, 95% CI = 0.52 to 0.93). Analyses of patients (103 of 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 homologous recombination deficiency–positive subgroup. ClinicalTrials.gov ID NCT02477644.