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

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,...

Descripción completa

Detalles Bibliográficos
Autores: Nishiyama, Hiroyuki, Yamamoto, Yoshiaki, Sassa, Naoto, Nishimura, Kazuo, Fujimoto, Kiyohide, Fukasawa, Satoshi, Yokoyama, Minato, Enokida, Hideki, Takahashi, Kenichi, Tanaka, Yoshinobu, Imai, Kentaro, Shimamoto, Takashi, Perini, Rodolfo, Frenkl, Tara, Bajorin, Dean F., Bellmunt Molins, Joaquim, 1959-
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/44914
Acceso en línea:http://hdl.handle.net/10230/44914
http://dx.doi.org/10.1007/s10147-019-01545-4
Access Level:acceso abierto
Palabra clave:Advanced urothelial cancer
Immune checkpoint blockade
Japanese
KEYNOTE-045
Pembrolizumab
id ES_26db40ee49843ba00a01e2924e2b2ea0
oai_identifier_str oai:recercat.cat:10230/44914
network_acronym_str ES
network_name_str España
repository_id_str
spelling Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045Nishiyama, HiroyukiYamamoto, YoshiakiSassa, NaotoNishimura, KazuoNishimura, KazuoFujimoto, KiyohideFukasawa, SatoshiYokoyama, MinatoEnokida, HidekiTakahashi, KenichiTanaka, YoshinobuImai, KentaroShimamoto, TakashiPerini, RodolfoFrenkl, TaraBajorin, Dean F.Bellmunt Molins, Joaquim, 1959-Advanced urothelial cancerImmune checkpoint blockadeJapaneseKEYNOTE-045PembrolizumabBackground: 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.SpringerOpen202020202020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/44914http://dx.doi.org/10.1007/s10147-019-01545-4reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésCopyright © 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.http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/449142026-05-29T05:05:01Z
dc.title.none.fl_str_mv Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
title Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
spellingShingle Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
Nishiyama, Hiroyuki
Advanced urothelial cancer
Immune checkpoint blockade
Japanese
KEYNOTE-045
Pembrolizumab
title_short Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
title_full Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
title_fullStr Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
title_full_unstemmed Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
title_sort Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045
dc.creator.none.fl_str_mv Nishiyama, Hiroyuki
Yamamoto, Yoshiaki
Sassa, Naoto
Nishimura, Kazuo
Nishimura, Kazuo
Fujimoto, Kiyohide
Fukasawa, Satoshi
Yokoyama, Minato
Enokida, Hideki
Takahashi, Kenichi
Tanaka, Yoshinobu
Imai, Kentaro
Shimamoto, Takashi
Perini, Rodolfo
Frenkl, Tara
Bajorin, Dean F.
Bellmunt Molins, Joaquim, 1959-
author Nishiyama, Hiroyuki
author_facet Nishiyama, Hiroyuki
Yamamoto, Yoshiaki
Sassa, Naoto
Nishimura, Kazuo
Fujimoto, Kiyohide
Fukasawa, Satoshi
Yokoyama, Minato
Enokida, Hideki
Takahashi, Kenichi
Tanaka, Yoshinobu
Imai, Kentaro
Shimamoto, Takashi
Perini, Rodolfo
Frenkl, Tara
Bajorin, Dean F.
Bellmunt Molins, Joaquim, 1959-
author_role author
author2 Yamamoto, Yoshiaki
Sassa, Naoto
Nishimura, Kazuo
Fujimoto, Kiyohide
Fukasawa, Satoshi
Yokoyama, Minato
Enokida, Hideki
Takahashi, Kenichi
Tanaka, Yoshinobu
Imai, Kentaro
Shimamoto, Takashi
Perini, Rodolfo
Frenkl, Tara
Bajorin, Dean F.
Bellmunt Molins, Joaquim, 1959-
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Advanced urothelial cancer
Immune checkpoint blockade
Japanese
KEYNOTE-045
Pembrolizumab
topic Advanced urothelial cancer
Immune checkpoint blockade
Japanese
KEYNOTE-045
Pembrolizumab
description 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.
publishDate 2020
dc.date.none.fl_str_mv 2020
2020
2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/44914
http://dx.doi.org/10.1007/s10147-019-01545-4
url http://hdl.handle.net/10230/44914
http://dx.doi.org/10.1007/s10147-019-01545-4
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv SpringerOpen
publisher.none.fl_str_mv SpringerOpen
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869404851261145088
score 15,81155

Similares en LA Referencia