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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorLe, Dung T.
dc.contributor.authorKim, Tae Won
dc.contributor.authorVan Cutsem, Eric
dc.contributor.authorGeva, Ravit
dc.contributor.authorJäger, Dirk
dc.contributor.authorHara, Hiroki
dc.contributor.authorElez Fernandez, Mª Elena
dc.date.accessioned2021-08-23T09:56:23Z
dc.date.available2021-08-23T09:56:23Z
dc.date.issued2020-01-01
dc.identifier.citationLe DT, Kim TW, Cutsem E Van, Geva R, Jäger D, Hara H, et al. Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: KEYNOTE-164. J Clin Oncol. 2020 Jan 1;38(1):11-19.
dc.identifier.issn1527-7755
dc.identifier.urihttp://hdl.handle.net/11351/6229
dc.descriptionPembrolizumab; Colorectal Cancer
dc.description.abstractPURPOSE KEYNOTE-164 (NCT02460198) evaluated the antitumor activity of pembrolizumab in previously treated, metastatic, microsatellite instability–high/mismatch repair–deficient (MSI-H/dMMR) colorectal cancer (CRC). METHODS This phase II open-label study involved 128 centers worldwide. Eligible patients were age ≥ 18 years and had metastatic MSI-H/dMMR CRC treated with ≥ 2 prior lines of standard therapy, including fluoropyrimidine, oxaliplatin, and irinotecan with or without anti–vascular endothelial growth factor/epidermal growth factor receptor monoclonal antibody (cohort A) or ≥ 1 prior line of therapy (cohort B). MSI-H/dMMR status was assessed locally. Patients received pembrolizumab 200 mg every 3 weeks for up to 2 years until progression, unacceptable toxicity, or withdrawal. The primary end point was objective response rate by RECIST version 1.1 by independent central review. Secondary end points were duration of response, progression-free survival (PFS), overall survival, safety, and tolerability. RESULTS A total of 124 patients with MSI-H/dMMR CRC (61 in cohort A, 63 in cohort B) enrolled. At data cutoff, median follow-up was 31.3 months (range, 0.2-35.6 months) for cohort A and 24.2 months (range, 0.1-27.1 months) for cohort B. Objective response rate was 33% (95% CI, 21% to 46%) and 33% (95% CI, 22% to 46%), respectively, with median duration of response not reached in either cohort. Median PFS was 2.3 months (95% CI, 2.1 to 8.1 months) and 4.1 months (95% CI, 2.1 to 18.9 months). Median overall survival was 31.4 months (95% CI, 21.4 months to not reached) and not reached (95% CI, 19.2 months to not reached). Treatment-related grade 3-4 adverse events occurred in 10 patients (16%) in cohort A and 8 (13%) in cohort B, with the most common occurring in ≥ 2 patients being pancreatitis, fatigue, increased alanine aminotransferase, and increased lipase (2 patients each; 3%) in cohort A. CONCLUSION Pembrolizumab is effective with a manageable safety profile in patients with MSI-H/dMMR CRC.
dc.language.isoeng
dc.publisherAmerican Society of Clinical Oncology
dc.relation.ispartofseriesJournal of Clinical Oncology;38(1)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectCòlon - Càncer
dc.subjectRecte - Càncer
dc.subjectMedicaments antineoplàstics - Ús terapèutic
dc.subject.meshColorectal Neoplasms
dc.subject.mesh/drug therapy
dc.subject.meshNeoplasm Metastasis
dc.titlePhase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability–High/Mismatch Repair–Deficient Metastatic Colorectal Cancer: KEYNOTE-164
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1200/JCO.19.02107
dc.subject.decsneoplasias colorrectales
dc.subject.decs/farmacoterapia
dc.subject.decsmetástasis neoplásica
dc.relation.publishversionhttps://ascopubs.org/doi/10.1200/JCO.19.02107
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Le DT] Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD. [Kim TW] Asan Medical Center, Seoul, Republic of Korea. [Van Cutsem E] University Hospitals Gasthuisberg Leuven, KU Leuven, Leuven, Belgium. [Geva R] Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. [Jäger D] Nationales Centrum Tumorerkrankungen, Heidelberg, Germany. [Hara H] Saitama Cancer Center, Saitama, Japan. [Elez E] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.identifier.pmid31725351
dc.identifier.wos000538777900002
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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