Browse

Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

DC Field Value Language
dc.contributor.authorHerbst, Roy S.-
dc.contributor.authorBaas, Paul-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorFelip, Enriqueta-
dc.contributor.authorPerez-Gracia, Jose L.-
dc.contributor.authorHan, Ji-Youn-
dc.contributor.authorMolina, Julian-
dc.contributor.authorKim, Joo-Hang-
dc.contributor.authorArvis, Catherine Dubos-
dc.contributor.authorAhn, Myung-Ju-
dc.contributor.authorMajem, Margarita-
dc.contributor.authorFidler, Mary J.-
dc.contributor.authorde Castro, Gilberto, Jr.-
dc.contributor.authorGarrido, Marcelo-
dc.contributor.authorLubiniecki, Gregory M.-
dc.contributor.authorShentu, Yue-
dc.contributor.authorIm, Ellie-
dc.contributor.authorDolled-Filhart, Marisa-
dc.contributor.authorGaron, Edward B.-
dc.date.accessioned2020-04-27T11:14:46Z-
dc.date.available2020-04-27T11:14:46Z-
dc.date.issued2016-04-
dc.identifier.citationThe Lancet, Vol.387 No.10027, pp.1540-1550-
dc.identifier.issn0140-6736-
dc.identifier.other47553-
dc.identifier.urihttp://hdl.handle.net/10371/165310-
dc.description.abstractBackground Despite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Methods We did this randomised, open-label, phase 2/3 study at 202 academic medical centres in 24 countries. Patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells were randomly assigned (1:1:1) in blocks of six per stratum with an interactive voice-response system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or docetaxel 75 mg/m(2) every 3 weeks. The primary endpoints were overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells. We used a threshold for significance of p<0.00825 (one-sided) for the analysis of overall survival and a threshold of p<0.001 for progression-free survival. This trial is registered at ClinicalTrials.gov, number NCT01905657. Findings Between Aug 28, 2013, and Feb 27, 2015, we enrolled 1034 patients:345 allocated to pembrolizumab 2 mg/kg, 346 allocated to pembrolizumab 10 mg/kg, and 343 allocated to docetaxel. By Sept 30, 2015, 521 patients had died. In the total population, median overall survival was 10.4 months with pembrolizumab 2 mg/kg, 12.7 months with pembrolizumab 10 mg/kg, and 8.5 months with docetaxel. Overall survival was significantly longer for pembrolizumab 2 mg/kg versus docetaxel (hazard ratio [HR] 0.71, 95% CI 0.58-0.88; p=0.0008) and for pembrolizumab 10 mg/kg versus docetaxel (0.61, 0.49-0.75; p<0.0001). Median progression-free survival was 3.9 months with pembrolizumab 2 mg/kg, 4.0 months with pembrolizumab 10 mg/kg, and 4.0 months with docetaxel, with no significant difference for pembrolizumab 2 mg/kg versus docetaxel (0.88, 0.74-1.05; p=0.07) or for pembrolizumab 10 mg/kg versus docetaxel (HR 0.79, 95% CI 0.66-0.94; p=0.004). Among patients with at least 50% of tumour cells expressing PD-L1, overall survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 14.9 months vs 8.2 months; HR 0.54, 95% CI 0.38-0.77; p=0.0002) and with pembrolizumab 10 mg/kg than with docetaxel (17.3 months vs 8.2 months; 0.50, 0.36-0.70; p<0.0001). Likewise, for this patient population, progression-free survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 5.0 months vs 4.1 months; HR 0.59, 95% CI 0.44-0.78; p=0.0001) and with pembrolizumab 10 mg/kg than with docetaxel (5.2 months vs 4.1 months; 0.59, 0.45-0.78; p<0.0001). Grade 3-5 treatment-related adverse events were less common with pembrolizumab than with docetaxel (43 [13%] of 339 patients given 2 mg/kg, 55 [16%] of 343 given 10 mg/kg, and 109 [35%] of 309 given docetaxel). Interpretation Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. These data establish pembrolizumab as a new treatment option for this population and validate the use of PD-L1 selection.-
dc.titlePembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial-
dc.typeArticle-
dc.contributor.AlternativeAuthor김동완-
dc.identifier.doi10.1016/S0140-6736(15)01281-7-
dc.citation.journaltitleThe Lancet-
dc.identifier.scopusid2-s2.0-84950117835-
dc.citation.endpage1550-
dc.citation.number10027-
dc.citation.startpage1540-
dc.citation.volume387-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0140673615012817?via%3Dihub-
dc.identifier.rimsid47553-
dc.identifier.sci000373741600030-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
Files in This Item:
There are no files associated with this item.
  • mendeley

Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse