The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma Journal Article


Authors: Colombo, N.; Oza, A. M.; Lorusso, D.; Aghajanian, C.; Oaknin, A.; Dean, A.; Weberpals, J. I.; Clamp, A. R.; Scambia, G.; Leary, A.; Holloway, R. W.; Gancedo, M. A.; Fong, P. C.; Goh, J. C.; O'Malley, D. M.; Armstrong, D. K.; Banerjee, S.; García-Donas, J.; Swisher, E. M.; Meunier, J.; Cameron, T.; Maloney, L.; Goble, S.; Bedel, J.; Ledermann, J. A.; Coleman, R. L.
Article Title: The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma
Abstract: Background: In the phase 3 trial ARIEL3, maintenance treatment with the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib provided clinical benefit versus placebo for patients with recurrent, platinum-sensitive ovarian cancer. Here, we evaluate the impact of age on the clinical utility of rucaparib in ARIEL3. Methods: Patients with platinum-sensitive, recurrent ovarian carcinoma with ≥2 prior platinum-based chemotherapies who responded to their last platinum-based therapy were enrolled in ARIEL3 and randomized 2:1 to rucaparib 600 mg twice daily or placebo. Exploratory, post hoc analyses of progression-free survival (PFS), patient-centered outcomes (quality-adjusted PFS [QA-PFS] and quality-adjusted time without symptoms or toxicity [Q-TWiST]), and safety were conducted in three age subgroups (<65 years, 65–74 years, and ≥75 years). Results: Investigator-assessed PFS was significantly longer with rucaparib than placebo in patients aged <65 years (rucaparib n = 237 vs placebo n = 117; median, 11.1 vs 5.4 months; hazard ratio [HR]: 0.33 [95% confidence interval (95% CI) 0.25–0.43]; P < 0.0001) and 65–74 years (n = 113 vs n = 64; median, 8.3 vs 5.3 months; HR 0.43 [95% CI 0.29–0.63]; P < 0.0001) and numerically longer in patients aged ≥75 years (n = 25 vs n = 8; median, 9.2 vs 5.5 months; HR 0.47 [95% CI 0.16–1.35]; P = 0.1593). QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups. Safety of rucaparib was generally similar across the age subgroups. Conclusions: Efficacy, patient-centered outcomes, and safety of rucaparib were similar between age subgroups, indicating that all eligible women with recurrent ovarian cancer should be offered this therapeutic option, irrespective of age. https://clinicaltrials.gov/ct2/show/NCT01968213. © 2020 The Authors
Keywords: ovarian cancer; maintenance; parp inhibitor; elderly patients; rucaparib
Journal Title: Gynecologic Oncology
Volume: 159
Issue: 1
ISSN: 0090-8258
Publisher: Elsevier Inc.  
Date Published: 2020-10-01
Start Page: 101
End Page: 111
Language: English
DOI: 10.1016/j.ygyno.2020.05.045
PUBMED: 32861537
PROVIDER: scopus
PMCID: PMC8450972
DOI/URL:
Notes: Article -- Export Date: 2 November 2020 -- Source: Scopus
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