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 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.