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dc.contributor.authorArrieta, Oscar
dc.contributor.authorBarrón-Barrón, Feliciano
dc.contributor.authorRamírez Tirado, Laura Alejandra
dc.contributor.authorZatarain-Barrón, Zyanya Lucia
dc.contributor.authorCardona, Andres
dc.contributor.authorDíaz-García, Diego
dc.contributor.authorYamamoto-Ramos, Masao
dc.contributor.authorMota-Vega, Beatriz
dc.contributor.authorCarmona, Amir
dc.contributor.authorPeralta-Alvarez, Marco Polo
dc.contributor.authorBautista, Yolanda
dc.contributor.authorAldaco, Fernando
dc.contributor.authorGerson, Raquel
dc.contributor.authorRolfo, Christian
dc.contributor.authorRosell, Rafael Costa
dc.date.accessioned2020-05-12T00:46:09Z
dc.date.available2020-05-12T00:46:09Z
dc.identifier.issn2374-2497spa
dc.identifier.urihttp://hdl.handle.net/20.500.12495/2601
dc.format.mimetypeapplication/pdfspa
dc.language.isoengspa
dc.publisherAmerican Medical Associationspa
dc.relation.ispartofseriesJAMA oncology, 2374-2497, 2020spa
dc.relation.urihttps://jamanetwork.com/journals/jamaoncology/article-abstract/2763865?utm_campaign=articlePDF%26utm_medium%3darticlePDFlink%26utm_source%3darticlePDF%26utm_content%3djamaoncol.2020.0409spa
dc.titleEfficacy and safety of pembrolizumab plus docetaxel vs docetaxel alone in patients with previously treated advanced non-small cell lung cancer: the PROLUNG Phase 2 randomized clinical trialspa
dc.typearticlespa
dc.type.localartículospa
dc.subject.decsNeoplasias pulmonaresspa
dc.subject.decsInmunoterapiaspa
dc.subject.decsDocetaxelspa
dc.subject.keywordsTargeted and immune cancer therapyspa
dc.subject.keywordsLung cancerspa
dc.subject.keywordsOncologyspa
dc.identifier.doihttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jamaoncol.2020.0409?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamaoncol.2020.0409spa
dc.type.hasversioninfo:eu-repo/semantics/publishedVersion
dc.publisher.journalJAMA oncologyspa
dc.type.coarhttp://purl.org/coar/resource_type/c_6501
dc.type.driverinfo:eu-repo/semantics/article
dc.identifier.instnameinstname:Universidad El Bosque
dc.identifier.reponamereponame:Repositorio Institucional Universidad El Bosque
dc.identifier.repourlhttps://repositorio.unbosque.edu.co
dc.title.translatedEfficacy and safety of pembrolizumab plus docetaxel vs docetaxel alone in patients with previously treated advanced non-small cell lung cancer: the PROLUNG Phase 2 randomized clinical trialspa
dc.description.abstractenglishImportance: Because of socioeconomic factors, many patients with advanced non-small cell lung cancer (NSCLC) do not receive immunotherapy in the first-line setting. It is unknown if the combination of immunotherapy with chemotherapy can provide clinical benefits in immunotherapy-naive patients with disease progression after treatment with platinum-based chemotherapy. Objective: To evaluate the safety and efficacy of the combination of pembrolizumab plus docetaxel in patients with previously treated advanced NSCLC following platinum-based chemotherapy regardless of EGFR variants or programmed cell death ligand 1 status. Design, Setting, and Participants: The Pembrolizumab Plus Docetaxel for Advanced Non-Small Cell Lung Cancer (PROLUNG) trial randomized 78 patients with histologically confirmed advanced NSCLC in a 1:1 ratio to receive either pembrolizumab plus docetaxel or docetaxel alone from December 2016 through May 2019. Interventions: The experimental arm received docetaxel on day 1 (75 mg/m2) plus pembrolizumab on day 8 (200 mg) every 3 weeks for up to 6 cycles followed by pembrolizumab maintenance until progression or unacceptable toxic effects. The control arm received docetaxel monotherapy. Main Outcomes and Measures: The primary end point was overall response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival, and safety. Results: Among 78 recruited patients, 32 (41%) were men, 34 (44%) were never smokers, and 25 (32%) had an EGFR/ALK alteration. Forty patients were allocated to receive pembrolizumab plus docetaxel, and 38 were allocated to receive docetaxel. A statistically significant difference in ORR, assessed by an independent reviewer, was found in patients receiving pembrolizumab plus docetaxel vs patients receiving docetaxel (42.5% vs 15.8%; odds ratio, 3.94; 95% CI, 1.34-11.54; P =.01). Patients without EGFR variations had a considerable difference in ORR of 35.7% vs 12.0% (P =.06), whereas patients with EGFR variations had an ORR of 58.3% vs 23.1% (P =.14). Overall, PFS was longer in patients who received pembrolizumab plus docetaxel (9.5 months; 95% CI, 4.2-not reached) than in patients who received docetaxel (3.9 months; 95% CI, 3.2-5.7) (hazard ratio, 0.24; 95% CI, 0.13-0.46; P <.001). For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (P <.001), whereas in patients with EGFR variations, PFS was 6.8 months (95% CI, 6.2-not reached) vs 3.5 months (95% CI, 2.3-6.2) (P =.04). In terms of safety, 23% (9 of 40) vs 5% (2 of 38) of patients experienced grade 1 to 2 pneumonitis in the pembrolizumab plus docetaxel and docetaxel arms, respectively (P =.03), while 28% (11 of 40) vs 3% (1 of 38) experienced any-grade hypothyroidism (P =.002). No new safety signals were identified. Conclusions and Relevance: In this phase 2 study, the combination of pembrolizumab plus docetaxel was well tolerated and substantially improved ORR and PFS in patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations. Trial Registration: ClinicalTrials.gov Identifier: NCT02574598.spa
dc.rights.localAcceso cerradospa
dc.rights.accessrightshttp://purl.org/coar/access_right/c_abf2
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess
dc.rights.accessrightsAcceso abiertospa
dc.date.issued2020


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