Patient-reported outcomes of maintenance rucaparib in patients with recurrent ovarian carcinoma in ARIEL3, a phase III, randomized, placebo-controlled trial

John Devin Peipert*, Sandra Goble, Jeff Isaacson, Xiaodan Tang, Katrine Wallace, Robert L. Coleman, Jonathan A. Ledermann, David Cella

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To compare NFOSI-18 Disease Related Symptoms – Physical (DRS[sbnd]P), Total score, and side effect bother between maintenance rucaparib (600 mg twice daily) vs. placebo in the phase III ARIEL3 trial. Methods: ARIEL3 (NCT01968213) included patients with ovarian carcinoma who responded to second-line or later platinum-based chemotherapy. The NFOSI-18 DRS-P and Total scales were secondary endpoints. The NFOSI-18 contains a side effect impact item (GP5): “I am bothered by side effects of treatment.” We compared treatment arms on change from baseline of DRS-P and Total scores using mixed models with repeated measures (MRMM). Time to first and confirmed deterioration of NFOSI-18 DRS-P and Total scales were analyzed using Cox regression. We also calculated the proportion of patients reporting moderate to high side effect bother on GP5. Results: In the intention-to-treat (ITT) cohort, mean change from baseline favored the placebo. Compared to placebo, rucaparib was associated with higher risk of deterioration [e.g., 4-point deteriorator definition hazard ratio (HR): 1.85; 95% CI: 1.46, 2.36; median time to first deterioration on DRS[sbnd]P: 1.9 vs. 7.0 months]. Confirmed deterioration results resembled those for first deterioration. Proportions of patients reporting moderate/high side effect bother on GP5 fluctuated around 20% across treatment cycles. Results in BRCA mutant and homologous recombination deficient cohorts were generally similar to those from the ITT cohort. Conclusion: This placebo-controlled study in the maintenance therapy setting provides a unique view of the impact of PARP inhibition on the patient-reported outcomes that are commonly used in ovarian cancer clinical trials. Information regarding the adverse side effect impact of PARP inhibitors should be weighed against their clinical benefit.

Original languageEnglish (US)
Pages (from-to)1-7
Number of pages7
JournalGynecologic oncology
Volume175
DOIs
StatePublished - Aug 2023

Keywords

  • ARIEL3 trial
  • PARP-inhibitors
  • Patient reported outcome
  • Quality of life
  • Rucaparib

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

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