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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorMcDermott, David F.
dc.contributor.authorLee, Jae-Lyun
dc.contributor.authorZiobro, Marek
dc.contributor.authorSuárez Rodríguez, Cristina
dc.contributor.authorLangiewicz, Przemyslaw
dc.contributor.authorMatveev, Vsevolod Borisovich
dc.date.accessioned2021-07-21T10:30:49Z
dc.date.available2021-07-21T10:30:49Z
dc.date.issued2021-03-20
dc.identifier.citationMcDermott DF, Lee JL, Ziobro M, Suarez C, Langiewicz P, Matveev VB, et al. Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1029-1039.
dc.identifier.issn1527-7755
dc.identifier.urihttp://hdl.handle.net/11351/6191
dc.descriptionRenal Cell Carcinoma; Pembrolizumab
dc.description.abstractPURPOSE Programmed death 1 (PD-1) pathway inhibitors have not been prospectively evaluated in patients with non–clear cell renal cell carcinoma (nccRCC). The phase II KEYNOTE-427 study (cohort B) was conducted to assess the efficacy and safety of single-agent pembrolizumab, a PD-1 inhibitor, in advanced nccRCC. METHODS Patients with histologically confirmed, measurable (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) nccRCC and no prior systemic therapy received pembrolizumab 200 mg intravenously once every 3 weeks for ≤ 24 months. The primary end point was objective response rate (ORR) per RECIST v1.1. RESULTS Among enrolled patients (N = 165), 71.5% had confirmed papillary, 12.7% had chromophobe, and 15.8% had unclassified RCC histology. Most patients (67.9%) had intermediate or poor International Metastatic RCC Database Consortium risk status and tumors with programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 1 (61.8%). The median time from enrollment to database cutoff was 31.5 months (range, 22.7-38.8). In all patients, the ORR was 26.7%. The median duration of response was 29.0 months; 59.7% of responses lasted ≥ 12 months. The ORR by CPS ≥ 1 and CPS < 1 status was 35.3% and 12.1%, respectively. The ORR by histology was 28.8% for papillary, 9.5% for chromophobe, and 30.8% for unclassified. Overall, the median progression-free survival was 4.2 months (95% CI, 2.9 to 5.6); the 24-month rate was 18.6%. The median overall survival was 28.9 months (95% CI, 24.3 months to not reached); the 24-month rate was 58.4%. Overall, 69.7% of patients reported treatment-related adverse events, most commonly pruritus (20.0%) and hypothyroidism (14.5%). Two deaths were treatment related (pneumonitis and cardiac arrest). CONCLUSION First-line pembrolizumab monotherapy showed promising antitumor activity in nccRCC. The safety profile was similar to that observed in other tumor types.
dc.language.isoeng
dc.publisherAmerican Society of Clinical Oncology
dc.relation.ispartofseriesJournal of Clinical Oncology;39(9)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectAdenocarcinoma
dc.subjectRonyons - Càncer
dc.subjectMedicaments antineoplàstics - Ús terapèutic
dc.subject.meshCarcinoma, Renal Cell
dc.subject.meshAntineoplastic Agents
dc.subject.mesh/therapeutic use
dc.titleOpen-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non–Clear Cell Renal Cell Carcinoma
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1200/JCO.20.02365
dc.subject.decscarcinoma de células renales
dc.subject.decsantineoplásicos
dc.subject.decs/uso terapéutico
dc.relation.publishversionhttps://ascopubs.org/doi/full/10.1200/JCO.20.02365
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[McDermott DF] Beth Israel Deaconess Medical Center, Boston, MA. [Lee JL] Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea. [Ziobro M] Centrum Onkologii-Instytut im. Marii Sklodowskiej, Cracow, Poland. [Suarez C] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Langiewicz P] Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON, Warszawa, Poland. [Matveev VB] N.N. Blokhin Russian Cancer Research Center, Moscow, Russia
dc.identifier.pmid33529058
dc.identifier.wos000655499200010
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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