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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorPoveda, Andres
dc.contributor.authorLheureux, S.
dc.contributor.authorColombo, Nicoletta
dc.contributor.authorCibula, David
dc.contributor.authorLindemann, Kristina
dc.contributor.authorWeberpals, J.
dc.contributor.authorOaknin Benzaquen, Ana Mazaltob
dc.date.accessioned2022-09-05T11:59:18Z
dc.date.available2022-09-05T11:59:18Z
dc.date.issued2022-03
dc.identifier.citationPoveda A, Lheureux S, Colombo N, Cibula D, Lindemann K, Weberpals J, et al. Olaparib maintenance monotherapy in platinum-sensitive relapsed ovarian cancer patients without a germline BRCA1/BRCA2 mutation: OPINION primary analysis. Gynecol Oncol. 2022 Mar;164(3):498–504.
dc.identifier.issn0090-8258
dc.identifier.urihttp://hdl.handle.net/11351/8029
dc.descriptionMaintenance; Olaparib; Ovarian cancer
dc.description.abstractObjective The phase IIIb OPINION trial (NCT03402841) investigated olaparib maintenance monotherapy in patients without a deleterious or suspected deleterious germline BRCA1/BRCA2 mutation (gBRCAm) who had platinum-sensitive relapsed ovarian cancer (PSROC) and had received ≥2 previous lines of platinum-based chemotherapy. Methods In this single-arm, open-label, international study, patients who had responded to platinum-based chemotherapy received maintenance olaparib tablets (300 mg twice daily) until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed progression-free survival (PFS) (modified RECIST version 1.1). A key secondary endpoint was PFS by homologous recombination deficiency (HRD) and somatic BRCAm (sBRCAm) status. The primary analysis of PFS was planned for 18 months after the last patient received their first dose. Results Two hundred and seventy-nine patients were enrolled and received olaparib. At data cutoff (October 2, 2020), 210 PFS events had occurred (75.3% maturity) and median PFS was 9.2 months (95% confidence interval [CI], 7.6–10.9) in the overall population. At 12 and 18 months, 38.5% and 24.3% of patients were progression-free, respectively. In the predefined biomarker subgroups, median PFS was 16.4, 11.1, 9.7, and 7.3 months in sBRCAm, HRD-positive including sBRCAm, HRD-positive excluding sBRCAm, and HRD-negative patients, respectively. The most common treatment-emergent adverse events (TEAEs) were nausea (48.4%) and fatigue/asthenia (44.1%). TEAEs led to dose interruption, dose reduction, and treatment discontinuation in 47.0%, 22.6%, and 7.5% of patients, respectively. Conclusion Maintenance olaparib demonstrated clinical benefit in patients without a gBRCAm, and across all subgroups, compared with historical placebo controls. There were no new safety signals.
dc.language.isoeng
dc.publisherElsevier
dc.relation.ispartofseriesGynecologic Oncology;164(3)
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectPlatí
dc.subjectOvaris - Càncer - Tractament
dc.subject.meshOvarian Neoplasms
dc.subject.mesh/drug therapy
dc.subject.meshPlatinum
dc.titleOlaparib maintenance monotherapy in platinum-sensitive relapsed ovarian cancer patients without a germline BRCA1/BRCA2 mutation: OPINION primary analysis
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1016/j.ygyno.2021.12.025
dc.subject.decsneoplasias ováricas
dc.subject.decs/farmacoterapia
dc.subject.decsplatino (metal)
dc.relation.publishversionhttps://doi.org/10.1016/j.ygyno.2021.12.025
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Poveda A] Initia Oncology, Valencia, Spain. [Lheureux S] Princess Margaret Hospital, Department of Medical Oncology, Toronto, ON, Canada. [Colombo N] University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy. [Cibula D] General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic. [Lindemann K] Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. [Weberpals J] Ottawa Hospital Research Institute, Ottawa, ON, Canada. [Oaknin A] Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain
dc.identifier.pmid35063276
dc.identifier.wos000809757900006
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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