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Article: Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial

TitlePembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial
Authors
Issue Date2018
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
Citation
The Lancet, 2018, v. 392 n. 10142, p. 123-133 How to Cite?
AbstractBackground: Patients with advanced gastric or gastro-oesophageal junction cancer that progresses on chemotherapy have poor outcomes. We compared pembrolizumab with paclitaxel in patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine. Methods: This randomised, open-label, phase 3 study was done at 148 medical centres in 30 countries. Eligible patients were randomised (1:1) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive either pembrolizumab 200 mg every 3 weeks for up to 2 years or standard-dose paclitaxel. Primary endpoints were overall survival and progression-free survival in patients with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or higher. Safety was assessed in all patients, irrespective of CPS. The significance threshold for overall survival was p=0·0135 (one-sided). This trial is registered at ClinicalTrials.gov, number NCT02370498. Findings: Between June 4, 2015, and July 26, 2016, 592 patients were enrolled. Of the 395 patients who had a PD-L1 CPS of 1 or higher, 196 patients were assigned to receive pembrolizumab and 199 patients were assigned to receive paclitaxel. As of Oct 26, 2017, 326 patients in the population with CPS of 1 or higher had died (151 [77%] of 196 patients in the pembrolizumab group and 175 [88%] of 199 patients in the paclitaxel group). Median overall survival was 9·1 months (95% CI 6·2–10·7) with pembrolizumab and 8·3 months (7·6–9·0) with paclitaxel (hazard ratio [HR] 0·82, 95% CI 0·66–1·03; one-sided p=0·0421). Median progression-free survival was 1·5 months (95% CI 1·4–2·0) with pembrolizumab and 4·1 months (3·1–4·2) with paclitaxel (HR 1·27, 95% CI 1·03–1·57). In the total population, grade 3–5 treatment-related adverse events occurred in 42 (14%) of the 294 patients treated with pembrolizumab and 96 (35%) of the 276 patients treated with paclitaxel. Interpretation: Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher. Pembrolizumab had a better safety profile than paclitaxel. Additional trials of pembrolizumab in gastric and gastro-oesophageal cancer are ongoing. Funding: Merck Sharp & Dohme, a subsidiary of Merck & Co.
Persistent Identifierhttp://hdl.handle.net/10722/281023
ISSN
2021 Impact Factor: 202.731
2020 SCImago Journal Rankings: 13.103
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorShitara, K-
dc.contributor.authorOzguroglu, M-
dc.contributor.authorBang, Y-J-
dc.contributor.authorBartolmeo, MD-
dc.contributor.authorMandala, M-
dc.contributor.authorRyu, M-H-
dc.contributor.authorFornaro, L-
dc.contributor.authorOlesinski, T-
dc.contributor.authorCaglevic, C-
dc.contributor.authorChung, HC-
dc.contributor.authorMuro, K-
dc.contributor.authorGoekkurt, E-
dc.contributor.authorMansoor, W-
dc.contributor.authorMcDermott, RS-
dc.contributor.authorShacham-Shumueli, E-
dc.contributor.authorChen, X-
dc.contributor.authorMayo, C-
dc.contributor.authorKang, SP-
dc.contributor.authorOhtsu, A-
dc.contributor.authorFuchs, CS-
dc.contributor.authorKEYNOTE-061 investigators-
dc.contributor.authorLam, KO-
dc.date.accessioned2020-02-28T01:22:31Z-
dc.date.available2020-02-28T01:22:31Z-
dc.date.issued2018-
dc.identifier.citationThe Lancet, 2018, v. 392 n. 10142, p. 123-133-
dc.identifier.issn0140-6736-
dc.identifier.urihttp://hdl.handle.net/10722/281023-
dc.description.abstractBackground: Patients with advanced gastric or gastro-oesophageal junction cancer that progresses on chemotherapy have poor outcomes. We compared pembrolizumab with paclitaxel in patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine. Methods: This randomised, open-label, phase 3 study was done at 148 medical centres in 30 countries. Eligible patients were randomised (1:1) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive either pembrolizumab 200 mg every 3 weeks for up to 2 years or standard-dose paclitaxel. Primary endpoints were overall survival and progression-free survival in patients with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or higher. Safety was assessed in all patients, irrespective of CPS. The significance threshold for overall survival was p=0·0135 (one-sided). This trial is registered at ClinicalTrials.gov, number NCT02370498. Findings: Between June 4, 2015, and July 26, 2016, 592 patients were enrolled. Of the 395 patients who had a PD-L1 CPS of 1 or higher, 196 patients were assigned to receive pembrolizumab and 199 patients were assigned to receive paclitaxel. As of Oct 26, 2017, 326 patients in the population with CPS of 1 or higher had died (151 [77%] of 196 patients in the pembrolizumab group and 175 [88%] of 199 patients in the paclitaxel group). Median overall survival was 9·1 months (95% CI 6·2–10·7) with pembrolizumab and 8·3 months (7·6–9·0) with paclitaxel (hazard ratio [HR] 0·82, 95% CI 0·66–1·03; one-sided p=0·0421). Median progression-free survival was 1·5 months (95% CI 1·4–2·0) with pembrolizumab and 4·1 months (3·1–4·2) with paclitaxel (HR 1·27, 95% CI 1·03–1·57). In the total population, grade 3–5 treatment-related adverse events occurred in 42 (14%) of the 294 patients treated with pembrolizumab and 96 (35%) of the 276 patients treated with paclitaxel. Interpretation: Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher. Pembrolizumab had a better safety profile than paclitaxel. Additional trials of pembrolizumab in gastric and gastro-oesophageal cancer are ongoing. Funding: Merck Sharp & Dohme, a subsidiary of Merck & Co.-
dc.languageeng-
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet-
dc.relation.ispartofThe Lancet-
dc.titlePembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial-
dc.typeArticle-
dc.identifier.emailLam, KO: lamkaon@hku.hk-
dc.identifier.authorityLam, KO=rp01501-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/S0140-6736(18)31257-1-
dc.identifier.pmid29880231-
dc.identifier.scopuseid_2-s2.0-85048592368-
dc.identifier.hkuros303031-
dc.identifier.volume392-
dc.identifier.issue10142-
dc.identifier.spage123-
dc.identifier.epage133-
dc.identifier.isiWOS:000438501300027-
dc.publisher.placeUnited Kingdom-
dc.identifier.issnl0140-6736-

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