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Article: Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer

TitlePembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer
Authors
Issue Date2016
Citation
New England Journal of Medicine, 2016, v. 375, n. 19, p. 1823-1833 How to Cite?
AbstractBACKGROUND Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1). METHODS In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator's choice of platinum-based chemotherapy. Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of disease progression. The primary end point, progression-free survival, was assessed by means of blinded, independent, central radiologic review. Secondary end points were overall survival, objective response rate, and safety. RESULTS Median progression-free survival was 10.3 months (95% confidence interval [CI], 6.7 to not reached) in the pembrolizumab group versus 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.37 to 0.68; P<0.001). The estimated rate of overall survival at 6 months was 80.2% in the pembrolizumab group versus 72.4% in the chemotherapy group (hazard ratio for death, 0.60; 95% CI, 0.41 to 0.89; P = 0.005). The response rate was higher in the pembrolizumab group than in the chemotherapy group (44.8% vs. 27.8%), the median duration of response was longer (not reached [range, 1.9+ to 14.5+ months] vs. 6.3 months [range, 2.1+ to 12.6+]), and treatment-related adverse events of any grade were less frequent (occurring in 73.4% vs. 90.0% of patients), as were grade 3, 4, or 5 treatment-related adverse events (26.6% vs. 53.3%). CONCLUSIONS In patients with advanced NSCLC and PD-L1 expression on at least 50% of tumor cells, pembrolizumab was associated with significantly longer progression-free and overall survival and with fewer adverse events than was platinum-based chemotherapy.
Persistent Identifierhttp://hdl.handle.net/10722/326469
ISSN
2023 Impact Factor: 96.2
2023 SCImago Journal Rankings: 20.544
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorReck, Martin-
dc.contributor.authorRodriguez-Abreu, Delvys-
dc.contributor.authorRobinson, Andrew G.-
dc.contributor.authorHui, Rina-
dc.contributor.authorCsöszi, Tibor-
dc.contributor.authorFülöp, Andrea-
dc.contributor.authorGottfried, Maya-
dc.contributor.authorPeled, Nir-
dc.contributor.authorTafreshi, Ali-
dc.contributor.authorCuffe, Sinead-
dc.contributor.authorO'Brien, Mary-
dc.contributor.authorRao, Suman-
dc.contributor.authorHotta, Katsuyuki-
dc.contributor.authorLeiby, Melanie A.-
dc.contributor.authorLubiniecki, Gregory M.-
dc.contributor.authorShentu, Yue-
dc.contributor.authorRangwala, Reshma-
dc.contributor.authorBrahmer, Julie R.-
dc.date.accessioned2023-03-10T02:19:30Z-
dc.date.available2023-03-10T02:19:30Z-
dc.date.issued2016-
dc.identifier.citationNew England Journal of Medicine, 2016, v. 375, n. 19, p. 1823-1833-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/326469-
dc.description.abstractBACKGROUND Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1). METHODS In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator's choice of platinum-based chemotherapy. Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of disease progression. The primary end point, progression-free survival, was assessed by means of blinded, independent, central radiologic review. Secondary end points were overall survival, objective response rate, and safety. RESULTS Median progression-free survival was 10.3 months (95% confidence interval [CI], 6.7 to not reached) in the pembrolizumab group versus 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.37 to 0.68; P<0.001). The estimated rate of overall survival at 6 months was 80.2% in the pembrolizumab group versus 72.4% in the chemotherapy group (hazard ratio for death, 0.60; 95% CI, 0.41 to 0.89; P = 0.005). The response rate was higher in the pembrolizumab group than in the chemotherapy group (44.8% vs. 27.8%), the median duration of response was longer (not reached [range, 1.9+ to 14.5+ months] vs. 6.3 months [range, 2.1+ to 12.6+]), and treatment-related adverse events of any grade were less frequent (occurring in 73.4% vs. 90.0% of patients), as were grade 3, 4, or 5 treatment-related adverse events (26.6% vs. 53.3%). CONCLUSIONS In patients with advanced NSCLC and PD-L1 expression on at least 50% of tumor cells, pembrolizumab was associated with significantly longer progression-free and overall survival and with fewer adverse events than was platinum-based chemotherapy.-
dc.languageeng-
dc.relation.ispartofNew England Journal of Medicine-
dc.titlePembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1056/NEJMoa1606774-
dc.identifier.pmid27718847-
dc.identifier.scopuseid_2-s2.0-84994802263-
dc.identifier.volume375-
dc.identifier.issue19-
dc.identifier.spage1823-
dc.identifier.epage1833-
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000387534200006-
dc.identifier.f1000726829941-

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