Rucaparib Extends PFS in Ovarian Cancer, Despite Toxic Effects

Focusing on patient-centered outcomes from the ARIEL3 trial, rucaparib extended progression-free survival (PFS) in the maintenance setting for ovarian carcinoma despite the impact of toxicities on patients’ health status (J Clin Oncol. 2020 Aug 24. Epub ahead of print).

The purpose of this retrospective analysis was to “investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo,” wrote Amit M. Oza, MD, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada, and co-investigators.

A total of 564 patients with platinum-sensitive, recurrent ovarian cancer were enrolled in the ARIEL3 trial from April 2014 to July 2016. Patients were randomly assigned in a 2:1 ratio to receive oral rucaparib 600 mg twice daily (n = 375) or placebo (n = 189).

QA-PFS for these analyses was calculated as progression-free survival function multiplied by the 3-level version of the EQ-5D questionnaire index score function. Q-TWIST analyses were performed with TOX as the mean duration a patient experienced grade 3 or worse treatment-emergent adverse events (TEAEs).

Follow-up cutoff was April 2017.  The QA-PFS difference between the rucaparib and placebo treatment arms was 6.28 months. The difference in mean Q-TWIST was 6.88 months between treatments arms. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to treat population and all other analysis groups, including BRCA-mutated cohorts.

“In our analyses, rucaparib provided significant benefits to patient health status even when accounting for toxicities, as demonstrated by QA-PFS and Q-TWiST analyses. These benefits were observed in the ITT population and in subgroups of patients with a BRCA-mutant carcinoma and those with a BRCA wild-type carcinoma,” said Dr Oza et al.

“Taken together, these findings demonstrated that rucaparib extended PFS in the maintenance setting without detrimental effects on patient health status,” they concluded.—Kaitlyn Manasterski