Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan

Nagase, Yoshikazu; Nakagawa, Satoshi; Kobayashi, Mariya; Kurahashi, Hiroki; Ogimoto, Hiromi; Tanaka, Ayaka; Tsujie, Tomoko; Shiomi, Mayu; Otake, Akiko; Masuhara, Kanji; Yoshikawa, Kenichi; Yotsumoto, Fusanori; Kurita, Tomoko; Yoshino, Kiyoshi; Yoshioka, Emi; Egawa-Takata, Tomomi; Kudaka, Wataru; Sekine, Masayuki; Unno, Hikari; Takemura, Masahiko; Aso, Saki; Kai, Kentaro; Kobayashi, Eiji; Yokoi, Takeshi; Akada, Masashi; Kakubari, Reisa; Hisa, Tsuyoshi; Matsuzaki, Shinya; Ueda, Yutaka

doi:https://doi.org/10.1007/s10147-025-02842-x

Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan

Nagase, Yoshikazu; Nakagawa, Satoshi; Kobayashi, Mariya et al.

International Journal of Clinical Oncology, 2025, 30, 2342-2351

アクセス数:802件（2026-02-10 08:10 集計）

固定URL: https://hdl.handle.net/11094/103003

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タイトル	Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan
著者	著者名 Nagase, Yoshikazu
	NRID 1000030650593 1000030650593 ORCID 0000-0001-6540-9040 0000-0001-6540-9040 researchmap permalink snakagawa snakagawa Scopus Author ID 56514567200 56514567200 著者名 Nakagawa, Satoshi
	ORCID 0000-0002-3658-4541 0000-0002-3658-4541 researchmap permalink mariya.k mariya.k Scopus Author ID 57269826700 57269826700 著者名 Kobayashi, Mariya
	著者名 Kurahashi, Hiroki
	著者名 Ogimoto, Hiromi
	著者名 Tanaka, Ayaka
	NRID 1000050362695 1000050362695 著者名 Tsujie, Tomoko
	著者名 Shiomi, Mayu
	著者名 Otake, Akiko
	著者名 Masuhara, Kanji
	著者名 Yoshikawa, Kenichi
	NRID 1000040533089 1000040533089 著者名 Yotsumoto, Fusanori
	NRID 1000030519864 1000030519864 著者名 Kurita, Tomoko
	NRID 1000090362730 1000090362730 著者名 Yoshino, Kiyoshi
	著者名 Yoshioka, Emi
	NRID 1000030437420 1000030437420 著者名 Egawa-Takata, Tomomi
	NRID 1000050529336 1000050529336 著者名 Kudaka, Wataru
	NRID 1000070345502 1000070345502 著者名 Sekine, Masayuki
	著者名 Unno, Hikari
	NRID 1000050294062 1000050294062 著者名 Takemura, Masahiko
	NRID 1000060962074 1000060962074 著者名 Aso, Saki
	NRID 1000090457622 1000090457622 著者名 Kai, Kentaro
	NRID 1000050614773 1000050614773 著者名 Kobayashi, Eiji
	著者名 Yokoi, Takeshi
	著者名 Akada, Masashi
	著者名 Kakubari, Reisa
	著者名 Hisa, Tsuyoshi
	NRID 1000000467565 1000000467565 ORCID 0000-0001-5725-9994 0000-0001-5725-9994 researchmap permalink shinya.matsuzaki shinya.matsuzaki Scopus Author ID 35201668600 35201668600 著者名 Matsuzaki, Shinya
	NRID 1000010346215 1000010346215 ORCID 0000-0001-8760-6379 0000-0001-8760-6379 researchmap permalink read0092318 read0092318 Scopus Author ID 55087087500 55087087500 著者名 Ueda, Yutaka
キーワード等	Endometrial cancer
	Lenvatinib
	Pembrolizumab
	Platinum-free interval
	Prognostic factors
内容	The version of record of this article, first published in International Journal of Clinical Oncology 30, 2342 (2025), is available online at Publisher’s website: https://doi.org/10.1007/s10147-025-02842-x
抄録	Background: Lenvatinib plus pembrolizumab (LP) therapy has emerged as an effective treatment for patients with advanced or recurrent endometrial cancer. However, limited data are available regarding its outcomes in real-world settings. This study aimed to identify prognostic factors associated with the efficacy of LP therapy. Methods: This multicenter observational study was conducted across 15 institutions in Japan and examined patients with endometrial cancer, including uterine carcinosarcoma, who experienced disease progression after receiving at least one platinum-based chemotherapy, including adjuvant treatment, and subsequently received LP therapy. The prognostic factors for progression-free survival were assessed using a multivariate Cox proportional hazards model. Results: A total of 105 patients met the inclusion criteria. Improved progression-free survival was independently associated with performance status of 0 (adjusted hazard ratio [aHR] 0.42, 95% confidence interval [CI] 0.23–0.75), platinum-free interval (PFI) of ≥ 6 months (aHR 0.46, 95% CI 0.28–0.78), histology of grade 1–2 endometrioid carcinoma (aHR 0.52, 95% CI 0.30–0.91), and relative dose intensity during the initial 8 weeks (8w-RDI) of lenvatinib of ≥ 50% (aHR 0.53, 95% CI 0.31–0.91). Patients with PFI of ≥ 6 months also demonstrated improved overall survival (HR 0.44, 95% CI 0.25–0.76) and objective response rate (44.0% versus 20.0%, P = 0.011) compared with those with PFI of < 6 months. Additionally, 8w-RDI of lenvatinib ≥ 50% was associated with improved overall survival (HR 0.53, 95% CI 0.30–0.92) compared to those with < 50%. Conclusions: This study identified several novel prognostic factors for LP therapy. Among them, PFI may inform treatment selection for recurrent endometrial cancer following chemotherapy. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) 000049997.
出版者	Springer
収録物名	International Journal of Clinical Oncology
巻(号)	30
ページ	2342-2351
刊行年月	2025-09-06
言語	英語
ハンドルURL	https://hdl.handle.net/11094/103003
PISSN	13419625
eISSN	14377772
関連情報 (isIdenticalTo)	DOI (出版社版) https://doi.org/10.1007/s10147-025-02842-x
アクセス権	open access
権利情報	This article is licensed under a Creative Commons Attribution 4.0 International License.
出版タイプ	Version of Record
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCMI資源タイプ	text
DCTERMS.bibliographicCitation	International Journal of Clinical Oncology. 2025, 30, p. 2342-2351
DC.title	Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan
DC.creator	Nagase, Yoshikazu
	Nakagawa, Satoshi
	Kobayashi, Mariya
	Kurahashi, Hiroki
	Ogimoto, Hiromi
	Tanaka, Ayaka
	Tsujie, Tomoko
	Shiomi, Mayu
	Otake, Akiko
	Masuhara, Kanji
	Yoshikawa, Kenichi
	Yotsumoto, Fusanori
	Kurita, Tomoko
	Yoshino, Kiyoshi
	Yoshioka, Emi
	Egawa-Takata, Tomomi
	Kudaka, Wataru
	Sekine, Masayuki
	Unno, Hikari
	Takemura, Masahiko
	Aso, Saki
	Kai, Kentaro
	Kobayashi, Eiji
	Yokoi, Takeshi
	Akada, Masashi
	Kakubari, Reisa
	Hisa, Tsuyoshi
	Matsuzaki, Shinya
	Ueda, Yutaka
DC.publisher	Springer
DC.language' scheme='DCTERMS.RFC1766	英語
DC.type' scheme='DCTERMS.DCMIType	text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2025-09-06
DC.identifier	https://doi.org/10.1007/s10147-025-02842-x
DC.subject	Endometrial cancer
	Lenvatinib
	Pembrolizumab
	Platinum-free interval
	Prognostic factors
DC.description	The version of record of this article, first published in International Journal of Clinical Oncology 30, 2342 (2025), is available online at Publisher’s website: https://doi.org/10.1007/s10147-025-02842-x
DCTERMS.abstract	Background: Lenvatinib plus pembrolizumab (LP) therapy has emerged as an effective treatment for patients with advanced or recurrent endometrial cancer. However, limited data are available regarding its outcomes in real-world settings. This study aimed to identify prognostic factors associated with the efficacy of LP therapy. Methods: This multicenter observational study was conducted across 15 institutions in Japan and examined patients with endometrial cancer, including uterine carcinosarcoma, who experienced disease progression after receiving at least one platinum-based chemotherapy, including adjuvant treatment, and subsequently received LP therapy. The prognostic factors for progression-free survival were assessed using a multivariate Cox proportional hazards model. Results: A total of 105 patients met the inclusion criteria. Improved progression-free survival was independently associated with performance status of 0 (adjusted hazard ratio [aHR] 0.42, 95% confidence interval [CI] 0.23–0.75), platinum-free interval (PFI) of ≥ 6 months (aHR 0.46, 95% CI 0.28–0.78), histology of grade 1–2 endometrioid carcinoma (aHR 0.52, 95% CI 0.30–0.91), and relative dose intensity during the initial 8 weeks (8w-RDI) of lenvatinib of ≥ 50% (aHR 0.53, 95% CI 0.31–0.91). Patients with PFI of ≥ 6 months also demonstrated improved overall survival (HR 0.44, 95% CI 0.25–0.76) and objective response rate (44.0% versus 20.0%, P = 0.011) compared with those with PFI of < 6 months. Additionally, 8w-RDI of lenvatinib ≥ 50% was associated with improved overall survival (HR 0.53, 95% CI 0.30–0.92) compared to those with < 50%. Conclusions: This study identified several novel prognostic factors for LP therapy. Among them, PFI may inform treatment selection for recurrent endometrial cancer following chemotherapy. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) 000049997.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	103003
citation_title	Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan
citation_author	Nagase, Yoshikazu
	Nakagawa, Satoshi
	Kobayashi, Mariya
	Kurahashi, Hiroki
	Ogimoto, Hiromi
	Tanaka, Ayaka
	Tsujie, Tomoko
	Shiomi, Mayu
	Otake, Akiko
	Masuhara, Kanji
	Yoshikawa, Kenichi
	Yotsumoto, Fusanori
	Kurita, Tomoko
	Yoshino, Kiyoshi
	Yoshioka, Emi
	Egawa-Takata, Tomomi
	Kudaka, Wataru
	Sekine, Masayuki
	Unno, Hikari
	Takemura, Masahiko
	Aso, Saki
	Kai, Kentaro
	Kobayashi, Eiji
	Yokoi, Takeshi
	Akada, Masashi
	Kakubari, Reisa
	Hisa, Tsuyoshi
	Matsuzaki, Shinya
	Ueda, Yutaka
citation_publisher	Springer
citation_language	英語
citation_date	2025-09-06
citation_journal_title	International Journal of Clinical Oncology
citation_volume	30
citation_firstpage	2342
citation_lastpage	2351
citation_doi	https://doi.org/10.1007/s10147-025-02842-x
citation_public_url	https://hdl.handle.net/11094/103003

Prognostic factors of lenvatinib plus pembrolizumab therapy for advanced or recurrent endometrial cancer: analysis of a multicenter cohort study in Japan

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