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    ORZORA: Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status

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    Authors
    Pignata, S.
    Oza, A.
    Hall, G.
    Pardo, B.
    Madry, R.
    Cibula, D.
    Klat, J.
    Montes, A.
    Glasspool, R.
    Colombo, N.
    Pete, I.
    Herrero, A.
    Marin, M. R.
    Ilieva, R.
    Timcheva, C.
    Blakeley, C.
    Taylor, R.
    Barnicle, A.
    Clamp, Andrew R
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    Affiliation
    Istituto Nazionale Tumori ‘Fondazione G Pascale’, IRCCS, Napoli, Italy, Napoli, Italy
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Objectives: The Phase III SOLO2 trial (NCT01874353) showed the significant benefit of maintenance olaparib for patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) and a BRCA mutation (BRCAm), compared with placebo (median progression-free survival [PFS] 19.1 vs 5.5 months [m], respectively); however, no pts had a confirmed somatic (s) BRCAm and data prospectively evaluating efficacy of olaparib in this pt group were limited. ORZORA (NCT02476968), an open-label, single-arm, multicenter trial, was conducted to assess efficacy and safety of maintenance olaparib in PSROC pts with a BRCAm (s or germline [g]) who were in response to their most recent platinum-based chemotherapy after ≥2 lines of treatment. Methods: Pts underwent prospective central screening for tumor BRCAm status (myChoice CDx, Myriad Genetic Laboratories, Inc.), then s or g BRCAm status was determined by central g testing (BRACAnalysis CDx, Myriad Genetic Laboratories, Inc.). Pts received maintenance olaparib (400 mg bid; capsules) until disease progression. Co-primary endpoints were investigator-assessed PFS (RECIST v1.1) in BRCAm and s cohorts, conducted at 60% maturity. Secondary endpoints included time to second progression or death (PFS2), health-related quality of life (HRQoL; FACT-O trial outcome index) and tolerability. An additional exploratory cohort comprised pts with predefined homologous recombination repair gene mutations (HRRm) excluding BRCAm (Foundatio CDx, Foundation Medicine, Inc.). Conclusions: PFS in pts with PSROC who received maintenance olaparib was similar irrespective of s or g BRCAm status. Activity of maintenance olaparib was also shown in pts with a non-BRCA HRRm. PFS, HRQoL and tolerability were consistent with previous olaparib studies in this population. Results highlight that PSROC pts beyond those with a gBRCAm can benefit from maintenance olaparib.
    Citation
    Pignata S, Oza A, Hall G, Pardo B, Madry R, Cibula D, et al. ORZORA: Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status. Gynecologic Oncology. 2021 Aug;162:S29.
    Journal
    Gynecologic Oncology
    URI
    http://hdl.handle.net/10541/624625
    DOI
    10.1016/S0090-8258(21)00700-9
    Additional Links
    https://dx.doi.org/10.1016/S0090-8258(21)00700-9
    Type
    Other
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/S0090-8258(21)00700-9
    Scopus Count
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