Table 5

Health-related quality-of-life measures incorporated in maintenance poly (ADP-ribose) polymerase inhibitor (PARPi) trials

Study/PARPiOutcome (primary/ relevant PRO)Statistical considerationsTime frameCompletion rateResults
First-Line Maintenance
SOLO1
Olaparib
FACT-ODifferences 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
DescriptiveQ8 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 differenceBaseline
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 monthsBaseline, 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
DescriptiveBaseline
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
NRFOSI 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.