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dc.creatorSchadendorf, Dirkes
dc.creatorLuke, Jason Johnes
dc.creatorAscierto, Paolo A.es
dc.creatorLong, Georgina V.es
dc.creatorRutkowski, Piotres
dc.creatorKhattak, Adnanes
dc.creatorCruz Merino, Luis de laes
dc.creatorScolyer, Richard A.es
dc.date.accessioned2024-03-18T16:18:01Z
dc.date.available2024-03-18T16:18:01Z
dc.date.issued2024
dc.identifier.citationSchadendorf, D., Luke, J.J., Ascierto, P.A., Long, G.V., Rutkowski, P., Khattak, A.,...,Scolyer, R.A. (2024). Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 trial. Journal for Immunotherapy of Cancer, 12 (3), e007501. https://doi.org/10.1136/jitc-2023-007501.
dc.identifier.issn2051-1426es
dc.identifier.urihttps://hdl.handle.net/11441/156401
dc.description.abstractBackground Adjuvant pembrolizumab significantly improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) versus placebo in the phase 3 KEYNOTE-716 study of resected stage IIB or IIC melanoma. At the prespecified third interim analysis (data cut-off, January 4, 2022), the HR for RFS in the overall population was 0.64 (95% CI, 0.50 to 0.84) and the HR for DMFS was 0.64 (95% CI, 0.47 to 0.88). We present a post hoc analysis of efficacy by subtypes defined by histopathologic characteristics. Methods Patients aged ≥12 years with newly diagnosed, resected stage IIB or IIC melanoma were randomly assigned (1:1) to pembrolizumab 200 mg every 3 weeks (2 mg/kg up to 200 mg for pediatric patients) or placebo. The primary end point was RFS per investigator review; DMFS per investigator review was secondary. Subgroups of interest were melanoma subtype (nodular vs non-nodular), tumor thickness (≤4 mm vs >4 mm), presence of ulceration (yes vs no), mitotic rate (<5 per mm2 (median) vs ≥5 per mm2), and presence of tumor-infiltrating lymphocytes (TILs; absent vs present). Results Between September 23, 2018, and November 4, 2020, 976 patients were assigned to pembrolizumab (n=487) or placebo (n=489). Median follow-up was 27.4 months (range, 14.0–39.4). The HR (95% CI) for RFS was 0.54 (0.37 to 0.79) for nodular and 0.77 (0.53 to 1.11) for non-nodular melanoma; 0.57 (0.37 to 0.89) for thickness ≤4 mm and 0.69 (0.50 to 0.96) for >4 mm; 0.66 (0.50 to 0.89) for ulceration and 0.57 (0.32 to 1.03) for no ulceration; 0.57 (0.35 to 0.92) for mitotic rate <5 per mm2 and 0.57 (0.40 to 0.80) for ≥5 per mm2; and 0.89 (0.52 to 1.54) for TILs absent and 0.51 (0.34 to 0.76) for TILs present. DMFS results were similar. In a Cox multivariate analysis, treatment arm, tumor thickness, and mitotic rate were significant independent factors for RFS, and treatment arm and mitotic rate were significant independent factors for DMFS. Conclusions In this post hoc analysis, the benefit of pembrolizumab was largely consistent with the overall study population regardless of histopathologic characteristics. These results support the use of adjuvant pembrolizumab in patients with resected stage IIB or IIC melanoma.es
dc.formatapplication/pdfes
dc.format.extent9 p.es
dc.language.isoenges
dc.publisherBMCes
dc.relation.ispartofJournal for Immunotherapy of Cancer, 12 (3), e007501.
dc.rightsAtribución-NoComercial 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/*
dc.titlePembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 triales
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.publisherversionhttps://jitc.bmj.com/content/12/3/e007501es
dc.identifier.doi10.1136/jitc-2023-007501es
dc.journaltitleJournal for Immunotherapy of Canceres
dc.publication.volumen12es
dc.publication.issue3es
dc.publication.initialPagee007501es

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