Health-related quality-of-life measures incorporated in maintenance poly (ADP-ribose) polymerase inhibitor (PARPi) trials
| Study/PARPi | Outcome (primary/ relevant PRO) | Statistical considerations | Time frame | Completion rate | Results |
| First-Line Maintenance | |||||
| SOLO1 Olaparib | FACT-O | Differences in TOI from baseline to 2 years. Significant 10 point difference | Baseline, D29 Q12 W for 3 years Q24 W until data cut-off | Baseline–W97: >80% | TOI score NS −3.00 points (95% CI −4.78 to −1.22) |
| PRIMA Niraparib | FOSI EQ-5D-5L EORTC-QLQ-C30/OV28 Neuropathy questionnaire | Descriptive | Q8 W (±7 days) for 56 W Q12 W, while on treatment. Discontinuation and 12 W after | >80% | NS |
| VELIA Veliparib | NFOSI-18 (EQ-5D-5L, as per protocol) | Significant 3 point difference | Baseline Prior to every other cycle Until PD or up to 2 years | 86% with adherence of >90% | NFOSI-18 NS (range 0.0 to 2.1) |
| Platinum-Sensitive Maintenance | |||||
| SOLO2 Olaparib | FACT-O EQ-5D-5L | Differences in TOI from baseline to 12 months | Baseline, W5, W13 Q12 W for 2 years or data cut-off 30 D from discontinuation, and Q12 W during follow-up (patients with PD) | At W49: >90% End of treatment: >65% | TOI score NS −0.03 points (–2.19 to 2.13) p=0.98 |
| NOVA Niraparib | FOSI EQ-5D-5L EQ-VAS | Descriptive | Baseline Q8 W for 14 cycles Q12 W thereafter Discontinuation and 8 W after | FOSI baseline–cycle 6: >85% Post-PD: >75% | FOSI and EQ-5D-5L NS Minimal changes during maintenance and post-PD |
| ARIEL3 Rucaparib | NFOSI-18 EQ-5D-3L | DRS-P: significant 4 point difference Total score: significant 8 point difference Step-down procedure for three subgroups (BRCAm, HRD, intention-to-treat) | Baseline D1 cycle Discontinuation and 28 D after | NR | FOSI DRS-P BRCAm NS Separate publication awaited |
D, day; DRS-P, Disease-Related Symptoms Physical subscale; EORTC-QLQ-C30/OV28, EORTC ovarian cancer module; EQ-5D-5L, European Quality of Life–5 Dimensions; EQ-VAS, EuroQol-Visual Analogue Scale; FACT-O, Functional Assessment of Cancer Therapy – Ovarian Cancer; HRD, homologous recombinant deficiency; NFOSI-18, 18-item form of FOSI questionnaire; NS, not significant; PD, progressive disease; PRO, patient-reported outcome; TOI, Trial Outcome Index; W, weeks.