Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial
- Author(s)
- Ledermann, JA; Oza, AM; Lorusso, D; Aghajanian, C; Oaknin, A; Dean, A; Colombo, N; Weberpals, JI; Clamp, AR; Scambia, G; Leary, A; Holloway, RW; Gancedo, MA; Fong, PC; Goh, JC; O'Malley, DM; Armstrong, DK; Banerjee, S; García-Donas, J; Swisher, EM; Lebreton, C; Konecny, GE; McNeish, IA; Scott, CL; Maloney, L; Goble, S; Lin, KK; Coleman, RL;
- Journal Title
- European Journal of Cancer
- Publication Type
- Research article
- Abstract
- BACKGROUND: In ARIEL3, rucaparib maintenance significantly improved progression-free survival (PFS; primary endpoint) and long-term follow-up (LTFU) outcomes (including PFS2: time to disease progression on subsequent therapy or death) versus placebo in patients with recurrent, platinum-sensitive ovarian cancer. Here we report the final analysis of overall survival (OS; key secondary endpoint), LTFU outcomes, and safety. METHODS: OS and updated LTFU efficacy outcomes were analyzed (data cutoff date: April 4, 2022) across three nested populations (BRCA-mutated, homologous recombination deficient [HRD], and intention to treat [ITT]). RESULTS: Patients were randomized 2:1 to rucaparib (600 mg BID; n = 375) or placebo (n = 189). Median follow-up was 77.0 months. 168 patients in the placebo arm received subsequent treatment; of these, 77 (46 %) received a poly(ADP-ribose) polymerase inhibitor-containing treatment. Median OS from randomization post chemotherapy for rucaparib vs placebo was 45.9 vs 47.8 months (HR 0.83, 95 % CI 0.58-1.19) for the BRCA-mutated population; no OS benefit was found with rucaparib in the HRD and ITT populations. Median PFS2 for rucaparib vs placebo was 26.1 vs 18.4 months (HR 0.67, 95 % CI 0.48-0.94) for the BRCA-mutated population. Rucaparib numerically improved PFS2 and other LTFU outcomes versus placebo in the HRD and ITT populations. Safety was consistent with prior reports; myelodysplastic syndrome and/or acute myeloid leukemia occurred in 4 % and 3 % of patients in the rucaparib and placebo arms, respectively. CONCLUSIONS: OS was similar between treatment arms. PFS benefit with rucaparib was maintained through the subsequent therapy line. These data support rucaparib as maintenance treatment for recurrent ovarian carcinoma.
- Publisher
- Elsevier
- Keywords
- Brca; Homologous recombination deficient; Long-term follow-up; Overall survival; Pfs2; Poly(ADP-ribose) polymerase inhibitor; Progression-free interval; Recurrent ovarian cancer
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1016/j.ejca.2025.115584
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-07-31 02:10:24
Last Modified: 2025-07-31 02:10:50