Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045

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  • dc.contributor.author Nishiyama, Hiroyuki
  • dc.contributor.author Yamamoto, Yoshiaki
  • dc.contributor.author Sassa, Naoto
  • dc.contributor.author Nishimura, Kazuo
  • dc.contributor.author Nishimura, Kazuo
  • dc.contributor.author Fujimoto, Kiyohide
  • dc.contributor.author Fukasawa, Satoshi
  • dc.contributor.author Yokoyama, Minato
  • dc.contributor.author Enokida, Hideki
  • dc.contributor.author Takahashi, Kenichi
  • dc.contributor.author Tanaka, Yoshinobu
  • dc.contributor.author Imai, Kentaro
  • dc.contributor.author Shimamoto, Takashi
  • dc.contributor.author Perini, Rodolfo
  • dc.contributor.author Frenkl, Tara
  • dc.contributor.author Bajorin, Dean F.
  • dc.contributor.author Bellmunt Molins, Joaquim, 1959-
  • dc.date.accessioned 2020-06-08T06:46:38Z
  • dc.date.available 2020-06-08T06:46:38Z
  • dc.date.issued 2020
  • dc.description.abstract Background: The open-label, randomized, active-controlled KEYNOTE-045 study (NCT02256436) showed that second-line pembrolizumab significantly improved overall survival (OS) of patients with advanced/metastatic urothelial cancer (UC) that progressed after first-line platinum-containing chemotherapy, compared with standard chemotherapy (paclitaxel, docetaxel, or vinflunine). Pembrolizumab is approved for patients with bladder cancer in Japan. Patients and methods: Analysis was performed in the subgroup of Japanese patients enrolled in the KEYNOTE-045 study. Coprimary end points were OS and progression-free survival (PFS). Objective response rate (ORR) and safety were secondary end points. Results: Fifty-two Japanese patients (pembrolizumab, n = 30; chemotherapy, n = 22) were followed up for a median of 26.1 months. Patients who received pembrolizumab compared with chemotherapy had a 19% lower risk for death (hazard ratio [HR] 0.81, 95% CI 0.44-1.50); after adjusting for baseline covariates, the HR for OS was 0.61 (95% CI 0.32-1.15). The 24-month OS rate was higher with pembrolizumab (26.9% vs 14.3%). PFS was 2.0 and 4.9 months for pembrolizumab and chemotherapy, respectively (HR 1.71, 95% CI 0.95-3.08). ORR was similar for pembrolizumab and chemotherapy (20.0% vs 18.2%); durability of response was higher with pembrolizumab: 67% and 33% of patients, respectively, maintained a response for > 12 months. Treatment-related adverse events, including grade 3-5 events, occurred less frequently with pembrolizumab. Conclusions: Pembrolizumab provided durable antitumor activity in patients with locally advanced/metastatic UC that progressed after platinum-containing chemotherapy in the overall population and in the Japanese subgroup; safety profile was consistent with that previously observed for pembrolizumab.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Nishiyama H, Yamamoto Y, Sassa N, Nishimura K, Fujimoto K, Fukasawa S,et al. Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045 trial. Int J Clin Oncol. 2020 Jan; 25(1):165-74. DOI: 10.1007/s10147-019-01545-4
  • dc.identifier.doi http://dx.doi.org/10.1007/s10147-019-01545-4
  • dc.identifier.issn 1341-9625
  • dc.identifier.uri http://hdl.handle.net/10230/44914
  • dc.language.iso eng
  • dc.publisher SpringerOpen
  • dc.rights Copyright © The Author(s) 2019. Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/
  • dc.subject.keyword Advanced urothelial cancer
  • dc.subject.keyword Immune checkpoint blockade
  • dc.subject.keyword Japanese
  • dc.subject.keyword KEYNOTE-045
  • dc.subject.keyword Pembrolizumab
  • dc.title Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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