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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorOaknin benzaquen, Ana Mazaltob
dc.contributor.authorFriedman, Claire F.
dc.contributor.authorRoman, Lynda D.
dc.contributor.authorD'Souza, Anishka
dc.contributor.authorBraña Garcia, Irene
dc.contributor.authorBidard, François-Clement
dc.date.accessioned2021-09-21T10:47:42Z
dc.date.available2021-09-21T10:47:42Z
dc.date.issued2020-10
dc.identifier.citationOaknin A, Friedman CF, Roman LD, D'Souza A, Brana I, Bidard FC, et al. Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial. Gynecol Oncol. 2020 Oct;159:150–6.
dc.identifier.issn0090-8258
dc.identifier.urihttp://hdl.handle.net/11351/6338
dc.descriptionCervical cancer; Clinical trial; HER2 mutant
dc.description.abstractObjective: Somatic HER2 mutations occur in ~5% of cervical cancers and are considered oncogenic and associated with poor prognosis. Neratinib, an irreversible pan-HER tyrosine kinase inhibitor, is active in multiple HER2-mutant cancers. SUMMIT is a phase II basket trial investigating the efficacy and safety of neratinib in solid tumors. Methods: Patients with HER2-mutant, persistent, metastatic/recurrent cervical cancer with disease progression after platinum-based treatment for advanced/recurrent disease received oral neratinib 240 mg/day with mandatory loperamide prophylaxis during cycle 1. The primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included: response duration (DOR); clinical benefit rate (CBR); progression-free survival (PFS); overall survival (OS); safety. Results: Sixteen eligible patients were enrolled; 10 (62.5%) had endocervical adenocarcinoma. The most common HER2 mutation was S310F (63% of patients). Three of 12 RECIST-measurable patients had confirmed partial responses (ORR 25%; 95%CI 5.5-57.2%); 3 had stable disease ≥16 weeks (CBR 50%; 95%CI 21.1-78.9%). DOR for responders were 5.6, 5.9, and 12.3 months. Median PFS was 7.0 months (95%CI 0.7-18.3 months); median OS was 16.8 months (95%CI 4.1-NE months). Diarrhea (75%), nausea (44%), and decreased appetite (38%) were the most common adverse events. One patient (6%) reported grade 3 diarrhea. There were no grade 4 events, and no diarrhea-related treatment discontinuations. Conclusions: Neratinib monotherapy showed evidence of activity in heavily pretreated patients with HER2-mutant cervical cancer, with no new safety signals. Given the few effective options for cervical cancer after platinum-based therapy failure, neratinib warrants further investigation in this molecularly defined patient population.
dc.language.isoeng
dc.publisherElsevier
dc.relation.ispartofseriesGynecologic Oncology;159
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectColl uterí - Càncer - Tractament
dc.subjectProteïnes quinases - Inhibidors
dc.subject.meshUterine Cervical Neoplasms
dc.subject.mesh/drug therapy
dc.subject.meshProtein Kinase Inhibitors
dc.titleNeratinib in patients with HER2 -mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1016/j.ygyno.2020.07.025
dc.subject.decsneoplasias del cuello uterino
dc.subject.decs/farmacoterapia
dc.subject.decsinhibidores de proteínas cinasas
dc.relation.publishversionhttps://doi.org/10.1016/j.ygyno.2020.07.025
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Oaknin A, Brana I] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Friedman CF] Memorial Sloan Kettering Cancer Center, New York, NY, USA. [Roman LD, D'Souza A] USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA. [Bidard FC] Institut Curie, St Cloud, France
dc.identifier.pmid32723675
dc.identifier.wos000576604900023
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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