Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort

Makino, Tomoki; Nakai, Shigeto; Momose, Kota; Yamashita, Kotaro; Tanaka, Koji; Miyata, Hiroshi; Yamamoto, Sachiko; Motoori, Masaaki; Kimura, Yutaka; Ushimaru, Yuki; Hirao, Motohiro; Matsuyama, Jin; Akamaru, Yusuke; Kurokawa, Yukinori; Eguchi, Hidetoshi; Doki, Yuichiro

doi:https://doi.org/10.1007/s10388-024-01056-w

Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort

Makino, Tomoki; Nakai, Shigeto; Momose, Kota et al.

Esophagus, 2024, 21, 319-327

Number of Access:1,893（2025-07-18 17:03 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/95792

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Title	Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort
Creator	NRID 1000080528620 1000080528620 researchmap permalink _-_-_- _-_-_- Scopus Author ID 56339970700 56339970700 CreatorName Makino, Tomoki
	NRID 1000040912027 1000040912027 CreatorName Nakai, Shigeto
	NRID 1000050749752 1000050749752 researchmap permalink kom2005 kom2005 CreatorName Momose, Kota
	NRID 1000020747159 1000020747159 researchmap permalink k-yamashita k-yamashita Scopus Author ID 57191498316 57191498316 CreatorName Yamashita, Kotaro
	CreatorName Tanaka, Koji
	NRID 1000080362713 1000080362713 CreatorName Miyata, Hiroshi
	CreatorName Yamamoto, Sachiko
	CreatorName Motoori, Masaaki
	NRID 1000080716994 1000080716994 CreatorName Kimura, Yutaka
	CreatorName Ushimaru, Yuki
	CreatorName Hirao, Motohiro
	CreatorName Matsuyama, Jin
	CreatorName Akamaru, Yusuke
	NRID 1000010470197 1000010470197 researchmap permalink krkw krkw Scopus Author ID 7202562410 7202562410 CreatorName Kurokawa, Yukinori
	NRID 1000090542118 1000090542118 researchmap permalink abcdabcdabcd abcdabcdabcd Scopus Author ID 7101627772 7101627772 CreatorName Eguchi, Hidetoshi
	NRID 1000020291445 1000020291445 researchmap permalink ydoki3251 ydoki3251 Scopus Author ID 7006390687 7006390687 CreatorName Doki, Yuichiro
Subject	Esophageal cancer
	Nivolumab
	Response rate
	Survival
Description	The version of record of this article, first published in Esophagus, is available online at Publisher’s website: https://doi.org/10.1007/s10388-024-01056-w.
Abstract	Background: Real-world clinical outcomes of and prognostic factors for nivolumab treatment for esophageal squamous-cell carcinoma (ESCC) remain unclear. This study aimed to evaluate real-world outcomes of nivolumab monotherapy in association with relevant clinical parameters in recurrent/unresectable advanced ESCC patients. Methods: This population-based multicenter cohort study included a total of 282 patients from 15 institutions with recurrent/unresectable advanced ESCC who received nivolumab as a second-line or later therapy between 2014 and 2022. Data, including the best overall response, progression-free survival (PFS), and overall survival (OS), were retrospectively collected from these patients. Results: Objective response and disease control rates were 17.0% and 47.9%, respectively. The clinical response to nivolumab treatment significantly correlated with development of overall immune-related adverse events (P <.0001), including rash (P <.0001), hypothyroidism (P =.03), and interstitial pneumonia (P =.004). Organ-specific best response rates were 20.6% in lymph nodes, 17.4% in lungs, 15.4% in pleural dissemination, and 13.6% in primary lesions. In terms of patient survival, the median OS and PFS was 10.9 and 2.4 months, respectively. Univariate analysis of OS revealed that performance status (PS; P <.0001), number of metastatic organs (P =.019), C-reactive protein-to-albumin ratio (CAR; P <.0001), neutrophil–lymphocyte ratio (P =.001), and PMI (P =.024) were significant. Multivariate analysis further identified CAR [hazard ratio (HR) = 1.61, 95% confidence interval (CI) 1.15–2.25, P =.0053)] in addition to PS (HR = 1.65, 95% CI 1.23–2.22, P =.0008) as independent prognostic parameters. Conclusions: CAR and PS before nivolumab treatment are useful in predicting long-term survival in recurrent/unresectable advanced ESCC patients with second-line or later nivolumab treatment.
Publisher	Springer
Source Title	Esophagus
Volume (Issue)	21
Page	319-327
Date of Issued	2024-05-08
Language	English
Handle URL	https://hdl.handle.net/11094/95792
PISSN	16129059
eISSN	16129067
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1007/s10388-024-01056-w
Access Rights	open access
CopyRight	This article is licensed under a Creative Commons Attribution 4.0 International License.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Esophagus. 2024, 21, p. 319-327
DC.title	Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort
DC.creator	Makino, Tomoki
	Nakai, Shigeto
	Momose, Kota
	Yamashita, Kotaro
	Tanaka, Koji
	Miyata, Hiroshi
	Yamamoto, Sachiko
	Motoori, Masaaki
	Kimura, Yutaka
	Ushimaru, Yuki
	Hirao, Motohiro
	Matsuyama, Jin
	Akamaru, Yusuke
	Kurokawa, Yukinori
	Eguchi, Hidetoshi
	Doki, Yuichiro
DC.publisher	Springer
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-05-08
DC.identifier	https://doi.org/10.1007/s10388-024-01056-w
DC.subject	Esophageal cancer
	Nivolumab
	Response rate
	Survival
DC.description	The version of record of this article, first published in Esophagus, is available online at Publisher’s website: https://doi.org/10.1007/s10388-024-01056-w.
DCTERMS.abstract	Background: Real-world clinical outcomes of and prognostic factors for nivolumab treatment for esophageal squamous-cell carcinoma (ESCC) remain unclear. This study aimed to evaluate real-world outcomes of nivolumab monotherapy in association with relevant clinical parameters in recurrent/unresectable advanced ESCC patients. Methods: This population-based multicenter cohort study included a total of 282 patients from 15 institutions with recurrent/unresectable advanced ESCC who received nivolumab as a second-line or later therapy between 2014 and 2022. Data, including the best overall response, progression-free survival (PFS), and overall survival (OS), were retrospectively collected from these patients. Results: Objective response and disease control rates were 17.0% and 47.9%, respectively. The clinical response to nivolumab treatment significantly correlated with development of overall immune-related adverse events (P <.0001), including rash (P <.0001), hypothyroidism (P =.03), and interstitial pneumonia (P =.004). Organ-specific best response rates were 20.6% in lymph nodes, 17.4% in lungs, 15.4% in pleural dissemination, and 13.6% in primary lesions. In terms of patient survival, the median OS and PFS was 10.9 and 2.4 months, respectively. Univariate analysis of OS revealed that performance status (PS; P <.0001), number of metastatic organs (P =.019), C-reactive protein-to-albumin ratio (CAR; P <.0001), neutrophil–lymphocyte ratio (P =.001), and PMI (P =.024) were significant. Multivariate analysis further identified CAR [hazard ratio (HR) = 1.61, 95% confidence interval (CI) 1.15–2.25, P =.0053)] in addition to PS (HR = 1.65, 95% CI 1.23–2.22, P =.0008) as independent prognostic parameters. Conclusions: CAR and PS before nivolumab treatment are useful in predicting long-term survival in recurrent/unresectable advanced ESCC patients with second-line or later nivolumab treatment.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	95792
citation_title	Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort
citation_author	Makino, Tomoki
	Nakai, Shigeto
	Momose, Kota
	Yamashita, Kotaro
	Tanaka, Koji
	Miyata, Hiroshi
	Yamamoto, Sachiko
	Motoori, Masaaki
	Kimura, Yutaka
	Ushimaru, Yuki
	Hirao, Motohiro
	Matsuyama, Jin
	Akamaru, Yusuke
	Kurokawa, Yukinori
	Eguchi, Hidetoshi
	Doki, Yuichiro
citation_publisher	Springer
citation_language	English
citation_date	2024-05-08
citation_journal_title	Esophagus
citation_volume	21
citation_firstpage	319
citation_lastpage	327
citation_doi	https://doi.org/10.1007/s10388-024-01056-w
citation_public_url	https://hdl.handle.net/11094/95792

Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort

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