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    Patient-centered outcomes in ARIEL3, a phase III, randomized, placebo-controlled trial of rucaparib maintenance treatment in patients with recurrent ovarian carcinoma

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    Authors
    Oza, A. M.
    Lorusso, D.
    Aghajanian, C.
    Oaknin, A.
    Dean, A.
    Colombo, N.
    Weberpals, J. I.
    Clamp, Andrew 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.
    Garcia-Donas, J
    Swisher, E. M.
    Cella, D.
    Meunier, J.
    Goble, S.
    Cameron, T.
    Maloney, L.
    Mork, AC
    Bedel, J.
    Ledermann, J. A.
    Coleman, R. L.
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    Affiliation
    Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
    Issue Date
    2020
    
    Metadata
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    Abstract
    Purpose: To investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo. Patients and methods: Patients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to rucaparib (600 mg twice per day) or placebo. QA-PFS was calculated as progression-free survival function � the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) index score function. Q-TWiST analyses were performed defining TOX as the mean duration in which a patient experienced grade ? 3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade ? 2 TEAEs of nausea, vomiting, fatigue, and asthenia. Q-TWiST was calculated as ?TOX � TOX + TWiST, with ?TOX calculated using EQ-5D-3L data. Results: The visit cutoff was Apr 15, 2017. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib v 189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]); BRCA-mutant cohort (130 rucaparib v 66 placebo; 9.37 months [95% CI, 6.65 to 11.85 months]); homologous recombination deficient (HRD) cohort (236 rucaparib v 118 placebo; 7.93 months [95% CI, 5.93 to 9.53 months]); and BRCA wild-type/loss of heterozygosity (LOH) low patient subgroup (107 rucaparib v 54 placebo; 2.71 months [95% CI, 0.31 to 4.44 months]). With TOX defined using grade ? 3 TEAEs, the difference in mean Q-TWiST (rucaparib v placebo) was 6.88 months (95% CI, 5.71 to 8.23 months), 9.73 months (95% CI, 7.10 to 11.94 months), 8.11 months (95% CI, 6.36 to 9.49 months), and 3.35 months (95% CI, 1.66 to 5.40 months) in the ITT population, BRCA-mutant cohort, HRD cohort, and BRCA wild-type/LOH low patient subgroup, respectively. Q-TWiST with TOX defined using select grade ? 2 TEAEs also consistently favored rucaparib. Conclusion: The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib versus placebo in all predefined cohorts.
    Citation
    Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Colombo N, et al. Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma. Journal of Clinical Oncology. 2020:JCO.19.03107.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/623270
    DOI
    10.1200/jco.19.03107
    PubMed ID
    32840418
    Additional Links
    https://dx.doi.org/10.1200/jco.19.03107
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/jco.19.03107
    Scopus Count
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