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    Rucaparib maintenance treatment for recurrent ovarian carcinoma: the effects of progression-free interval and prior therapies on efficacy and safety in the randomized phase III trial ARIEL3

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    Authors
    Clamp, Andrew R
    Lorusso, D.
    Oza, A. M.
    Aghajanian, C.
    Oaknin, A.
    Dean, A.
    Colombo, N.
    Weberpals, J. I.
    Scambia, G.
    Leary, A.
    Holloway, R. W.
    Amenedo Gancedo, M.
    Fong, P. C.
    Goh, J. C.
    O'Malley, D. M.
    Armstrong, D. K.
    Banerjee, S.
    García-Donas, J.
    Swisher, E. M.
    Cameron, T.
    Goble, S.
    Coleman, R. L
    Ledermann, J. A.
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    Affiliation
    Department of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Introduction: In ARIEL3 (NCT01968213), the poly(adenosine diphosphate-ribose) polymerase inhibitor rucaparib significantly improved progression-free survival versus placebo regardless of biomarker status when used as maintenance treatment for recurrent ovarian cancer. The aim of the current analyses was to evaluate the efficacy and safety of rucaparib in subgroups based on progression-free interval following penultimate platinum, number of prior chemotherapies, and prior use of bevacizumab. Methods: Patients were randomized 2:1 to rucaparib 600 mg twice daily or placebo. Within subgroups, progression-free survival was assessed in prespecified, nested cohorts: BRCA-mutant, homologous recombination deficient (BRCA-mutant or wild-type BRCA/high genomic loss of heterozygosity), and the intent-to-treat population. Results: In the intent-to-treat population, median investigator-assessed progression-free survival was 8.2 months with rucaparib versus 4.1 months with placebo (n=151 vs n=76; HR 0.33, 95% CI 0.24 to 0.46, p<0.0001) for patients with progression-free interval 6 to ≤12 months, and 13.6 versus 5.6 months (n=224 vs n=113; HR 0.39, 95% CI 0.30 to 0.52, p<0.0001) for those with progression-free interval >12 months. Median progression-free survival was 10.4 versus 5.4 months (n=231 vs n=124; HR 0.42, 95% CI 0.32 to 0.54, p<0.0001) for patients who had received two prior chemotherapies, and 11.1 versus 5.3 months (n=144 vs n=65; HR 0.28, 95% CI 0.19 to 0.41, p<0.0001) for those who had received ≥3 prior chemotherapies. Median progression-free survival was 10.3 versus 5.4 months (n=83 vs n=43; HR 0.42, 95% CI 0.26 to 0.68, p=0.0004) for patients who had received prior bevacizumab, and 10.9 versus 5.4 months (n=292 vs n=146; HR 0.35, 95% CI 0.28 to 0.45, p<0.0001) for those who had not. Across subgroups, median progression-free survival was also significantly longer with rucaparib versus placebo in the BRCA-mutant and homologous recombination deficient cohorts. Safety was consistent across subgroups. Conclusions: Rucaparib maintenance treatment significantly improved progression-free survival versus placebo irrespective of progression-free interval following penultimate platinum, number of lines of prior chemotherapy, and previous use of bevacizumab.
    Citation
    Clamp AR, Lorusso D, Oza AM, Aghajanian C, Oaknin A, Dean A, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma: the effects of progression-free interval and prior therapies on efficacy and safety in the randomized phase III trial ARIEL3. Int J Gynecol Cancer . 2021 Jun 8;31(7):949–58.
    Journal
    International Journal of Gynecologic Cancer
    URI
    http://hdl.handle.net/10541/624226
    DOI
    10.1136/ijgc-2020-002240
    PubMed ID
    34103386
    Additional Links
    https://dx.doi.org/10.1136/ijgc-2020-002240
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1136/ijgc-2020-002240
    Scopus Count
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