Quality-adjusted progression-free survival (PFS) and time without symptoms or toxicity in women with recurrent ovarian cancer were longer with rucaparib compared with placebo, according to a study published online in the Journal of Clinical Oncology (2020;38[30]:3494-3505. doi:10.1200/JCO.19.03107).
“By evaluating quality-adjusted survival, which incorporates assessments of quality and quantity of life, we demonstrated that rucaparib maintenance treatment provided significant benefit despite the impact of toxicities on patients’ health status during rucaparib treatment and that patients receiving rucaparib had longer periods without clinically relevant symptoms,” wrote Amit M. Oza, MD, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada, and colleagues.
This post hoc analysis explored quality-adjusted PFS and time without symptoms or toxicity among participants in the ARIEL3 trial, in which patients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to receive rucaparib (600 mg twice a day) or placebo.
Average quality-adjusted PFS was significantly longer (6.28 months) with rucaparib compared with placebo in the intent-to-treat (ITT) population (among whom 375 received rucaparib and 189 placebo).
Additionally, quality-adjusted PFS was 9.37 months longer with rucaparib in the BRCA-mutant cohort (130 received rucaparib and 66 placebo); 7.93 months longer in the homologous recombination deficient cohort (236 received rucaparib and 118 placebo); and 2.71 months longer in the BRCA wild-type/loss of heterozygosity low patient subgroup (107 received rucaparib and 54 placebo).
Differences in average quality-adjusted time without symptoms or toxicity were also better with rucaparib compared with placebo. Quality-adjusted time without symptoms or toxicity for grade ≥3 treatment-emergent adverse events was 6.88 months longer with rucaparib compared to placebo in the ITT population, 9.73 months longer in the BRCA-mutant cohort, 8.11 months longer in the homologous recombination deficient cohort, and 3.35 months longer in the BRCA wild-type/loss of heterozygosity low patient subgroup.
Researchers noted that results continued to favor rucaparib when toxicities were defined as grade 2 or higher treatment-emergent nausea, vomiting, fatigue, and asthenia.
“The significant differences in quality-adjusted progression-free survival and quality-adjusted time without symptoms or toxicity confirm the benefit of rucaparib versus placebo in all predefined cohorts,” Dr Oza and colleagues concluded.—Jolynn Tumolo
