Impact of disease progression on health-related quality of life (HRQOL): Updated results from the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line (1L) maintenance therapy in patients with newly diagnosed advanced ovarian cancer (aOC).

5551 Background: The phase 3 PRIMA trial (NCT02655016) demonstrated that niraparib 1L maintenance therapy significantly extended progression-free survival (PFS) compared with placebo in patients with newly diagnosed aOC that responded to 1L platinum-based chemotherapy. Using data from the Nov 2019 cutoff (median follow-up, ≈1.7 y), pooled results from both treatment arms found that disease progression negatively affected HRQOL. Here we report updated HRQOL results from the PRIMA final analysis. Methods: In PRIMA, patients were randomized 2:1 to niraparib or placebo 1L maintenance once daily. HRQOL was assessed as a prespecified secondary endpoint using patient-reported responses to multiple instruments, including the European Organisation for Research and Treatment of Cancer QOL Core Questionnaire (EORTC QLQ-C30) and the EORTC QLQ Ovarian Cancer Module (EORTC QLQ-OV28). Assessments were collected at baseline, at designated intervals while on study treatment; at the end of treatment (EOT); and at 4, 8, 12, and 24 weeks after the last dose of study treatment. Post hoc analysis results are reported herein (clinical cutoff: Apr 8, 2024; median follow-up, 6.2 y). Results: In the overall population (niraparib, n=487; placebo, n=246), EOT survey completion rates exceeded 80% across both instruments. In both treatment arms, disease progression significantly reduced overall HRQOL per the EORTC QLQ-C30, with marked decreases from the last on-treatment visit (LOTV) for global health status/QOL that never recovered to LOTV levels (Table). Disease progression was also associated with deterioration across all 5 functional scales of the EORTC QLQ-C30 and worsening symptoms of fatigue, nausea/vomiting, pain, dyspnea, appetite loss, diarrhea, and financial difficulties. On the EORTC QLQ-OV28, progression was associated with decreased scores for body image, sexuality, and attitude toward disease/treatment functional scales and worsening abdominal/gastrointestinal symptoms. Conclusions: Disease progression negatively impacted HRQOL across treatment arms in PRIMA. These results support PFS as a clinically relevant endpoint in patients with aOC, as delays in disease progression help preserve HRQOL. Clinical trial information: NCT02655016 . LS mean change from LOTV (95% CI) Niraparib(n=487) Placebo(n=246) EORTC QLQ-C30 global health status/QOL EOT –8.6 (–10.9, –6.4) –7.4 (–10.1, –4.7) Week 4 post EOT –10.0 (–12.7, –7.3) –10.7 (–14.0, –7.4) Week 8 post EOT –10.1 (–12.9, –7.2) –12.2 (–16.0, –8.5) Week 12 post EOT –11.5 (–14.0, –9.1) –9.5 (–12.6, –6.3) Week 24 post EOT –10.7 (–13.4, –8.1) –9.6 (–13.1, –6.2) EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer QOL Core Questionnaire; EOT, end of treatment; LOTV, last on-treatment visit; LS, least squares; QOL, quality of life.