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dc.creatorRamalingam, Suresh S.es
dc.creatorNovello, Silviaes
dc.creatorGuclu, Salih Zekies
dc.creatorBentsion, Dmitryes
dc.creatorZvirbule, Zanetees
dc.creatorSzilasi, Mariaes
dc.creatorBernabé-Caro, Reyeses
dc.date.accessioned2022-10-31T19:01:51Z
dc.date.available2022-10-31T19:01:51Z
dc.date.issued2021
dc.identifier.citationRamalingam, S.S., Novello, S., Guclu, S.Z., Bentsion, D., Zvirbule, Z., Szilasi, M. y Bernabe Caro, M. . (2021). Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. Journal of Clinical Oncology, 39 (32), 3633-3644. https://doi.org/10.1200/JCO.20.03318.
dc.identifier.issn0732-183xes
dc.identifier.issn1527-7755es
dc.identifier.urihttps://hdl.handle.net/11441/138557
dc.description.abstractPURPOSE Squamous non–small-cell lung cancer (sqNSCLC) is genetically complex with evidence of DNA damage. This phase III study investigated the efficacy and safety of poly (ADP-ribose) polymerase inhibitor veliparib in combination with conventional chemotherapy for advanced sqNSCLC (NCT02106546). PATIENTS AND METHODS Patients age ≥ 18 years with untreated, advanced sqNSCLC were randomly assigned 1:1 to carboplatin and paclitaxel with veliparib 120 mg twice daily (twice a day) or placebo twice a day for up to six cycles. The primary end point was overall survival (OS) in the veliparib arm versus the control arm in current smokers, based on phase II findings. Archival tumor samples were provided for biomarker analysis using a 52-gene expression histology classifier (LP52). RESULTS Overall, 970 patients were randomly assigned to carboplatin and paclitaxel plus either veliparib (n = 486) or placebo (n = 484); 57% were current smokers. There was no significant OS benefit with veliparib in current smokers, with median OS 11.9 versus 11.1 months (hazard ratio [HR], 0.905; 95% CI, 0.744 to 1.101; P = .266). In the overall population, OS favored veliparib; median OS was 12.2 versus 11.2 months (HR, 0.853; 95% CI, 0.747 to 0.974), with no difference in progression-free survival (median 5.6 months per arm). In patients with biomarker-evaluable tumor samples (n = 360), OS favored veliparib in the LP52-positive population (median 14.0 v 9.6 months; HR, 0.66; 95% CI, 0.49 to 0.89), but favored placebo in the LP52-negative population (median 11.0 v 14.4 months; HR, 1.33; 95% CI, 0.95 to 1.86). No new safety signals were observed in the experimental arm. CONCLUSION In current smokers with advanced sqNSCLC, there was no therapeutic benefit of adding veliparib to first-line chemotherapy. The LP52 signature may identify a subgroup of patients likely to derive benefit from veliparib with chemotherapy.es
dc.format.extent13 p.es
dc.language.isoenges
dc.publisherAmerican Society Clinical Oncologyes
dc.relation.ispartofJournal of Clinical Oncology, 39 (32), 3633-3644.
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectVeliparibes
dc.subjectChemotherapyes
dc.subjectPlatinumes
dc.subjectLung Canceres
dc.subjectSquamous Celles
dc.titleVeliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Studyes
dc.typeinfo:eu-repo/semantics/articlees
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Medicinaes
dc.relation.publisherversionhttp://doi.org/10.1200/JCO.20.03318es
dc.identifier.doi10.1200/JCO.20.03318es
dc.journaltitleJournal of Clinical Oncologyes
dc.publication.volumen39es
dc.publication.issue32es
dc.publication.initialPage3633es
dc.publication.endPage3644es

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