Clinical outcomes of first-line combination therapy with immune checkpoint inhibitor for metastatic non-clear cell renal cell carcinoma: a multi-institutional retrospective study in Japan

Yoshimura, Akihiro; Kato, Taigo; Nakai, Yasutomo; Tsujihata, Masao; Toyoda, Shingo; Sato, Mototaka; Matsuzaki, Kyosuke; Nakata, Wataru; Takao, Tetsuya; Inoguchi, Syunsuke; Okuda, Yohei; Yamamichi, Gaku; Ishizuya, Yu; Yamamoto, Yoshiyuki; Hatano, Koji; Kawashima, Atsunari; Takada, Shingo; Inoue, Hitoshi; Nishimura, Kensaku; Miyake, Osamu; Fujita, Kazutoshi; Nakayama, Masashi; Nishimura, Kazuo; Nonomura, Norio

doi:https://doi.org/10.1007/s10147-024-02612-1

Clinical outcomes of first-line combination therapy with immune checkpoint inhibitor for metastatic non-clear cell renal cell carcinoma: a multi-institutional retrospective study in Japan

Yoshimura, Akihiro; Kato, Taigo; Nakai, Yasutomo et al.

International Journal of Clinical Oncology, 2024, 29(12), 1916-1924

Number of Access:3,780（2025-10-12 17:09 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/98275

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Title	Clinical outcomes of first-line combination therapy with immune checkpoint inhibitor for metastatic non-clear cell renal cell carcinoma: a multi-institutional retrospective study in Japan
Creator	NRID 1000070981992 1000070981992 CreatorName Yoshimura, Akihiro
	NRID 1000070648021 1000070648021 researchmap permalink taigokato taigokato Scopus Author ID 55414697500 55414697500 ORCID 0000-0002-8681-1407 0000-0002-8681-1407 CreatorName Kato, Taigo
	CreatorName Nakai, Yasutomo
	CreatorName Tsujihata, Masao
	CreatorName Toyoda, Shingo
	CreatorName Sato, Mototaka
	NRID 1000090747081 1000090747081 CreatorName Matsuzaki, Kyosuke
	CreatorName Nakata, Wataru
	NRID 1000030379177 1000030379177 CreatorName Takao, Tetsuya
	CreatorName Inoguchi, Syunsuke
	NRID 1000010964372 1000010964372 ORCID 0000-0001-9909-4200 0000-0001-9909-4200 researchmap permalink okudayohei okudayohei CreatorName Okuda, Yohei
	NRID 1000040882262 1000040882262 researchmap permalink urology-osaka-japan urology-osaka-japan CreatorName Yamamichi, Gaku
	NRID 1000000783854 1000000783854 researchmap permalink okiishi okiishi CreatorName Ishizuya, Yu
	NRID 1000090759557 1000090759557 researchmap permalink yoshi229 yoshi229 ORCID 0000-0002-1271-3521 0000-0002-1271-3521 CreatorName Yamamoto, Yoshiyuki
	NRID 1000060762234 1000060762234 researchmap permalink koji_hatano koji_hatano Scopus Author ID 14627167600 14627167600 CreatorName Hatano, Koji
	NRID 1000050746568 1000050746568 researchmap permalink akawashima akawashima Scopus Author ID 9846139400 9846139400 CreatorName Kawashima, Atsunari
	NRID 1000000379249 1000000379249 CreatorName Takada, Shingo
	CreatorName Inoue, Hitoshi
	CreatorName Nishimura, Kensaku
	CreatorName Miyake, Osamu
	NRID 1000050636181 1000050636181 CreatorName Fujita, Kazutoshi
	NRID 1000040379178 1000040379178 CreatorName Nakayama, Masashi
	NRID 1000080303957 1000080303957 CreatorName Nishimura, Kazuo
	NRID 1000030263263 1000030263263 researchmap permalink read0185096 read0185096 Scopus Author ID 7005880662 7005880662 CreatorName Nonomura, Norio
Subject	Immune checkpoint inhibitor
	Immune-related adverse event
	Non-clear cell renal cell carcinoma
	Renal cell carcinoma
Description	The version of record of this article, first published in International Journal of Clinical Oncology, is available online at Publisher’s website: https://doi.org/10.1007/s10147-024-02612-1.
Abstract	Background: In metastatic clear cell renal cell carcinoma (ccRCC), recent studies have shown promising efficacy of immune checkpoint inhibitor (ICI) combination therapy. However, there are insufficient evidences about clinical efficacy and safety of ICI combination therapy in metastatic non-ccRCC (nccRCC). Methods: We retrospectively investigated 44 patients treated with nivolumab plus ipilimumab (ICI + ICI group) or anti-PD-1/PD-L1 inhibitor plus tyrosine kinase inhibitors (TKI) (ICI + TKI group), and assessed clinical efficacy in both groups. Results: Of all patients, overall response rate and disease control rate for ICI combination treatments were 36.3% and 75%, respectively. The median progression-free survival (PFS) and overall survival (OS) was 8.8 and 23.9 months, respectively. Multivariate analysis revealed that the presence of liver metastasis significantly affected worse PFS and OS (p = 0.035 and p = 0.049). Importantly, PFS and OS seemed similar in ICI + ICI group and ICI + TKI group (p = 0.778 and p = 0.559). Although the discontinuation rate of the combination therapy due to adverse effects in patients aged ≥ 75 years was significantly higher compared to that in patients aged < 75 years (45% versus 12%, p = 0.017), there were no significant differences in PFS and OS between two groups (p = 0.290 and p = 0.257, respectively). Conclusion: This study confirms clinical benefit of ICI combination therapy for metastatic nccRCC patients in real-world settings. Furthermore, the effectiveness of combination therapy was comparable between patients aged < 75 and those ≥75 years with respect to clinical prognosis.
Publisher	Springer
Source Title	International Journal of Clinical Oncology
Volume (Issue)	29(12)
Page	1916-1924
Date of Issued	2024-09-02
Language	English
Handle URL	https://hdl.handle.net/11094/98275
PISSN	13419625
eISSN	14377772
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1007/s10147-024-02612-1
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
DCTERMS.bibliographicCitation	International Journal of Clinical Oncology. 2024, 29(12), p. 1916-1924
DC.title	Clinical outcomes of first-line combination therapy with immune checkpoint inhibitor for metastatic non-clear cell renal cell carcinoma: a multi-institutional retrospective study in Japan
DC.creator	Yoshimura, Akihiro
	Kato, Taigo
	Nakai, Yasutomo
	Tsujihata, Masao
	Toyoda, Shingo
	Sato, Mototaka
	Matsuzaki, Kyosuke
	Nakata, Wataru
	Takao, Tetsuya
	Inoguchi, Syunsuke
	Okuda, Yohei
	Yamamichi, Gaku
	Ishizuya, Yu
	Yamamoto, Yoshiyuki
	Hatano, Koji
	Kawashima, Atsunari
	Takada, Shingo
	Inoue, Hitoshi
	Nishimura, Kensaku
	Miyake, Osamu
	Fujita, Kazutoshi
	Nakayama, Masashi
	Nishimura, Kazuo
	Nonomura, Norio
DC.publisher	Springer
DC.language' scheme='DCTERMS.RFC1766	English
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-09-02
DC.identifier	https://doi.org/10.1007/s10147-024-02612-1
DC.subject	Immune checkpoint inhibitor
	Immune-related adverse event
	Non-clear cell renal cell carcinoma
	Renal cell carcinoma
DC.description	The version of record of this article, first published in International Journal of Clinical Oncology, is available online at Publisher’s website: https://doi.org/10.1007/s10147-024-02612-1.
DCTERMS.abstract	Background: In metastatic clear cell renal cell carcinoma (ccRCC), recent studies have shown promising efficacy of immune checkpoint inhibitor (ICI) combination therapy. However, there are insufficient evidences about clinical efficacy and safety of ICI combination therapy in metastatic non-ccRCC (nccRCC). Methods: We retrospectively investigated 44 patients treated with nivolumab plus ipilimumab (ICI + ICI group) or anti-PD-1/PD-L1 inhibitor plus tyrosine kinase inhibitors (TKI) (ICI + TKI group), and assessed clinical efficacy in both groups. Results: Of all patients, overall response rate and disease control rate for ICI combination treatments were 36.3% and 75%, respectively. The median progression-free survival (PFS) and overall survival (OS) was 8.8 and 23.9 months, respectively. Multivariate analysis revealed that the presence of liver metastasis significantly affected worse PFS and OS (p = 0.035 and p = 0.049). Importantly, PFS and OS seemed similar in ICI + ICI group and ICI + TKI group (p = 0.778 and p = 0.559). Although the discontinuation rate of the combination therapy due to adverse effects in patients aged ≥ 75 years was significantly higher compared to that in patients aged < 75 years (45% versus 12%, p = 0.017), there were no significant differences in PFS and OS between two groups (p = 0.290 and p = 0.257, respectively). Conclusion: This study confirms clinical benefit of ICI combination therapy for metastatic nccRCC patients in real-world settings. Furthermore, the effectiveness of combination therapy was comparable between patients aged < 75 and those ≥75 years with respect to clinical prognosis.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	98275
citation_title	Clinical outcomes of first-line combination therapy with immune checkpoint inhibitor for metastatic non-clear cell renal cell carcinoma: a multi-institutional retrospective study in Japan
citation_author	Yoshimura, Akihiro
	Kato, Taigo
	Nakai, Yasutomo
	Tsujihata, Masao
	Toyoda, Shingo
	Sato, Mototaka
	Matsuzaki, Kyosuke
	Nakata, Wataru
	Takao, Tetsuya
	Inoguchi, Syunsuke
	Okuda, Yohei
	Yamamichi, Gaku
	Ishizuya, Yu
	Yamamoto, Yoshiyuki
	Hatano, Koji
	Kawashima, Atsunari
	Takada, Shingo
	Inoue, Hitoshi
	Nishimura, Kensaku
	Miyake, Osamu
	Fujita, Kazutoshi
	Nakayama, Masashi
	Nishimura, Kazuo
	Nonomura, Norio
citation_publisher	Springer
citation_language	English
citation_date	2024-09-02
citation_journal_title	International Journal of Clinical Oncology
citation_volume	29
citation_issue	12
citation_firstpage	1916
citation_lastpage	1924
citation_doi	https://doi.org/10.1007/s10147-024-02612-1
citation_public_url	https://hdl.handle.net/11094/98275

Clinical outcomes of first-line combination therapy with immune checkpoint inhibitor for metastatic non-clear cell renal cell carcinoma: a multi-institutional retrospective study in Japan

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