Trial reportJournal of the National Cancer Institute2026
Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25).
Trial report in Journal of the National Cancer Institute, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02477644 (Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment), which is not on this map. Not yet cited in PubMed.
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Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment
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Abstract
backgroundWe 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.
methodsHealth-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.
resultsA 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.
conclusionAdding 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.
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