Rucaparib Safe Regardless of Age

According to research presented at the 2019 Society of Gynecologic Oncology Annual Meeting, there were no significant differences in outcomes based on age among recurrent ovarian carcinoma patients taking rucaparib. The study analyzed data from ARIEL3, a randomized, placebo-controlled study in which patients randomized 2:1 received either oral rucaparib (600 BID) or placebo. The researchers stratified patients into three subgroups based on patient age at baseline—< 65 years, 65-74 years, or ≥ 75 years—and evaluated progression-free survival (PFS) and safety. Efficacy and safety visit cutoff dates were April 15, 2017, and Aug. 15, 2017, respectively.

The age < 65 years group had more patients with a deleterious germline or somatic BRCA mutation (rucaparib, n = 96 [40.5%]; placebo, n = 49 [41.9%]) compared to the 65-74 years (rucaparib, n = 29 [25.7%]; placebo, n = 15 [23.4%]) and ≥ 75 years (rucaparib, n = 5 [20.0%]; placebo, n = 2 [25.0%]) groups. Median PFS in the patient age < 65 years group was 11.1 months (n = 237) in the rucaparib group compared to 5.4 months (n = 117) among placebo patients (hazard ratio [HR] = 0.33; 95% confidence interval [CI] 0.25–0.43). In the age 65-74 years cohort, median PFS was 8.3 months (n = 113) versus 5.3 months, respectively (n = 64; HR = 0.43; 95% CI 0.29–0.64). In the age ≥ 75 years cohort, median PFS was 9.2 months (n = 25) versus 5.5 months, respectively (n = 8; HR = 0.47; 95% CI 0.16–1.35). The most common treatment-emergent adverse events (TEAEs) in the treatment arm of all three subgroups were nausea and asthenia. The most common hematologic TEAEs in rucaparib patients in all three groups included anemia and thrombocytopenia.

The authors concluded that maintenance rucaparib treatment was associated with better PFS and progression outcomes compared to placebo, with a similar safety profile regardless of age. They also noted that dose modification and treatment discontinuation trends differed across the subgroups, without a clear trend emerging.

Ledermanna JA, Ozab AM, Lorusso D, et al. The effect of age on efficacy and safety outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase III, randomized, placebo-controlled maintenance study in patients with recurrent ovarian carcinoma.