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Article: Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer

TitlePembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer
Authors
Issue Date2018
Citation
New England Journal of Medicine, 2018, v. 378, n. 22, p. 2078-2092 How to Cite?
AbstractBACKGROUND First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial. METHODS In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. Crossover to pembrolizumab monotherapy was permitted among the patients in the placebo-combination group who had verified disease progression. The primary end points were overall survival and progression-free survival, as assessed by blinded, independent central radiologic review. RESULTS After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab- combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebocombination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P<0.001). Improvement in overall survival was seen across all PD-L1 categories that were evaluated. Median progression-free survival was 8.8 months (95% CI, 7.6 to 9.2) in the pembrolizumab-combination group and 4.9 months (95% CI, 4.7 to 5.5) in the placebo-combination group (hazard ratio for disease progression or death, 0.52; 95% CI, 0.43 to 0.64; P<0.001). Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group. CONCLUSIONS In patients with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to standard chemotherapy of pemetrexed and a platinum-based drug resulted in significantly longer overall survival and progression-free survival than chemotherapy alone.
Persistent Identifierhttp://hdl.handle.net/10722/326476
ISSN
2023 Impact Factor: 96.2
2023 SCImago Journal Rankings: 20.544
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorGandhi, L.-
dc.contributor.authorRodríguez-Abreu, D.-
dc.contributor.authorGadgeel, S.-
dc.contributor.authorEsteban, E.-
dc.contributor.authorFelip, E.-
dc.contributor.authorDe Angelis, F.-
dc.contributor.authorDomine, M.-
dc.contributor.authorClingan, P.-
dc.contributor.authorHochmair, M. J.-
dc.contributor.authorPowell, S. F.-
dc.contributor.authorCheng, S. Y.S.-
dc.contributor.authorBischoff, H. G.-
dc.contributor.authorPeled, N.-
dc.contributor.authorGrossi, F.-
dc.contributor.authorJennens, R. R.-
dc.contributor.authorReck, M.-
dc.contributor.authorHui, R.-
dc.contributor.authorGaron, E. B.-
dc.contributor.authorBoyer, M.-
dc.contributor.authorRubio-Viqueira, B.-
dc.contributor.authorNovello, S.-
dc.contributor.authorKurata, T.-
dc.contributor.authorGray, J. E.-
dc.contributor.authorVida, J.-
dc.contributor.authorWei, Z.-
dc.contributor.authorYang, J.-
dc.contributor.authorRaftopoulos, H.-
dc.contributor.authorPietanza, M. C.-
dc.contributor.authorGarassino, M. C.-
dc.date.accessioned2023-03-10T02:19:33Z-
dc.date.available2023-03-10T02:19:33Z-
dc.date.issued2018-
dc.identifier.citationNew England Journal of Medicine, 2018, v. 378, n. 22, p. 2078-2092-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/326476-
dc.description.abstractBACKGROUND First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial. METHODS In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. Crossover to pembrolizumab monotherapy was permitted among the patients in the placebo-combination group who had verified disease progression. The primary end points were overall survival and progression-free survival, as assessed by blinded, independent central radiologic review. RESULTS After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab- combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebocombination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P<0.001). Improvement in overall survival was seen across all PD-L1 categories that were evaluated. Median progression-free survival was 8.8 months (95% CI, 7.6 to 9.2) in the pembrolizumab-combination group and 4.9 months (95% CI, 4.7 to 5.5) in the placebo-combination group (hazard ratio for disease progression or death, 0.52; 95% CI, 0.43 to 0.64; P<0.001). Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group. CONCLUSIONS In patients with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to standard chemotherapy of pemetrexed and a platinum-based drug resulted in significantly longer overall survival and progression-free survival than chemotherapy alone.-
dc.languageeng-
dc.relation.ispartofNew England Journal of Medicine-
dc.titlePembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1056/NEJMoa1801005-
dc.identifier.pmid29658856-
dc.identifier.scopuseid_2-s2.0-85047328215-
dc.identifier.volume378-
dc.identifier.issue22-
dc.identifier.spage2078-
dc.identifier.epage2092-
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000433428000006-

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