{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T05:40:02Z","timestamp":1748497202686,"version":"3.41.0"},"reference-count":35,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100012781","name":"MSD K.K.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100012781","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Post-marketing surveillance focusing on hepatic function disorder was requested owing to its higher incidence in the pembrolizumab plus axitinib group than in the sunitinib group in KEYNOTE-426. We aimed to evaluate the prevalence and risk factors of adverse events (AEs) of hepatic function disorder in patients with unresectable\/metastatic renal cell carcinoma (RCC) treated with pembrolizumab plus axitinib in real-world clinical practice in Japan.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Patients were observed for 9\u00a0months after starting treatment with pembrolizumab plus axitinib.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>In total, 193 patients were included in the safety analysis set (median age, 70\u00a0years). Most patients did not have a history of hepatic function disorder before starting treatment (96.4%, 186\/193). The median treatment period was 27.1\u00a0weeks. At the 9-month data cut-off, 62.2% (120\/193) of patients discontinued treatment, the most common reason being any AE in 31.1% (60\/193). The incidence of AEs of hepatic function disorder was 30.1% (58\/193) for any grade and 15.0% (29\/193) for grade\u2009\u2265\u20093. Most AEs of hepatic function disorder occurred within 3\u00a0months from starting treatment. AEs of hepatic function disorder were the reason for discontinuation of pembrolizumab in 9.3% (18\/193) of patients; axitinib, 7.3% (14\/193); and both pembrolizumab and axitinib, 5.2% (10\/193). No background factors were identified as being associated with the occurrence of AEs of hepatic function disorder.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>There were no new safety signals for AEs of hepatic function disorder, and the incidence was consistent with that reported in KEYNOTE-426, in Japanese patients with radically unresectable\/metastatic RCC treated with pembrolizumab plus axitinib.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s10147-025-02708-2","type":"journal-article","created":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T07:03:56Z","timestamp":1745910236000},"page":"1229-1236","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Adverse events of hepatic function disorder in Japanese patients with radically unresectable or metastatic renal cell carcinoma treated with pembrolizumab plus axitinib: a post-marketing surveillance study"],"prefix":"10.1007","volume":"30","author":[{"given":"Mototsugu","family":"Oya","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shotaro","family":"Yasuoka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-7091-5898","authenticated-orcid":false,"given":"Takuto","family":"Tokudome","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihiko","family":"Minegishi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Hamada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiko","family":"Ozaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinichiroh","family":"Maekawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuichiro","family":"Ito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,4,29]]},"reference":[{"key":"2708_CR1","doi-asserted-by":"publisher","first-page":"209","DOI":"10.3322\/caac.21660","volume":"71","author":"H Sung","year":"2021","unstructured":"Sung H, Ferlay J, Siegel RL et al (2021) Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 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SY, TT, M Ozaki, and SM are employees of MSD and hold stock or stock options in Merck & Co., Inc., Rahway, NJ, USA. TM is an employee of MSD and holds stock or stock options in Merck & Co., Inc., Rahway, NJ, USA, and GlaxoSmithKline. MH is an employee of MSD and holds stock or stock options in Merck & Co., Inc., Rahway, NJ, USA, and Organon & Co. YI is an employee of MSD and holds stock or stock options in Merck & Co., Inc., Rahway, NJ, USA, and Bayer AG.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}