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Here, we report long-term outcomes from this study in the overall population and subgroups stratified by subsequent chemotherapy.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this multicenter, retrospective observational study, Japanese patients with recurrent or metastatic (R\/M) HNC receiving nivolumab were followed up for 2\u00a0years. Effectiveness endpoints included overall survival (OS), OS rate, progression-free survival (PFS), and PFS rate. Safety endpoints included the incidence of immune-related adverse events (irAEs).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Overall, 256 patients received a median of 6.0 doses (range: 1\u201352) of nivolumab over a median duration of 72.5\u00a0days (range: 1\u2013736). Median OS was 9.5\u00a0months [95% confidence interval (CI) 8.2\u201312.0] and median PFS was 2.1\u00a0months (95% CI 1.8\u20132.7). A significant difference between 2-year survivors (<jats:italic>n<\/jats:italic>\u2009=\u200962) and non-2-year survivors was observed by median age (<jats:italic>P<\/jats:italic>\u2009=\u20090.0227) and ECOG PS (<jats:italic>P<\/jats:italic>\u2009=\u20090.0001). Of 95 patients who received subsequent chemotherapy, 54.7% received paclitaxel\u2009\u00b1\u2009cetuximab. The median OS and PFS from the start of paclitaxel\u2009\u00b1\u2009cetuximab were 6.9\u00a0months (95% CI 5.9\u201311.9) and 3.5\u00a0months (95% CI 2.3\u20135.5), respectively. IrAEs were reported in 17.2% of patients. Endocrine (7.0%) and lung (4.3%) disorders were the most common irAEs; kidney disorder (<jats:italic>n<\/jats:italic>\u2009=\u20091) was newly identified in this follow-up analysis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Results demonstrated the\u00a0long-term effectiveness of nivolumab and potential effectiveness of subsequent chemotherapy in patients with R\/M HNC in the real-world setting. Safety was consistent with that over the 1-year follow-up.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10147-021-02047-y","type":"journal-article","created":{"date-parts":[[2021,11,13]],"date-time":"2021-11-13T08:02:51Z","timestamp":1636790571000},"page":"95-104","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study"],"prefix":"10.1007","volume":"27","author":[{"given":"Ryuji","family":"Yasumatsu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Shimizu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuhiro","family":"Hanai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin","family":"Kariya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoya","family":"Yokota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Fujii","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyoaki","family":"Tsukahara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mizuo","family":"Ando","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Hanyu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsutomu","family":"Ueda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitoshi","family":"Hirakawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunji","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeharu","family":"Ono","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Sano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moriyasu","family":"Yamauchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihito","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Omori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoko","family":"Yamazaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuya","family":"Monden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi","family":"Kudo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Arai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syuji","family":"Yonekura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Asakage","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Nekado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Yamada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1488-0646","authenticated-orcid":false,"given":"Akihiro","family":"Homma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,11,13]]},"reference":[{"key":"2047_CR1","doi-asserted-by":"publisher","first-page":"1856","DOI":"10.1056\/NEJMoa1602252","volume":"375","author":"RL Ferris","year":"2016","unstructured":"Ferris RL, Blumenschein GJ, Fayette J et al (2016) Nivolumab for recurrent squamous-cell carcinoma of the head and neck. 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Yasumatsu reports grants from Ono Pharmaceutical Co., Ltd. during the conduct of the study. N. Hanai, K. Omori, and A. Homma report grants from Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. during the conduct of the study. T. Yokota reports an advisory role for Merck Biopharma and personal fees from Bristol-Myers Squibb K.K, Merck Biopharma, and Ono Pharmaceutical Co., Ltd. during the conduct of the study. K. Tsukahara reports personal fees from Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. during the conduct of the study. S. Takahashi reports grants and personal fees from AstraZeneca K.K., Bayer, Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., MSD, and Ono Pharmaceutical Co., Ltd. during the conduct of the study. T. Ueda reports a grant from Ono Pharmaceutical Co., Ltd. during the conduct of the study. T. Yamazaki reports grants from AstraZeneca K.K., Bristol-Myers Squibb K.K., and Ono Pharmaceutical Co., Ltd. during the conduct of the study. T. Yamada is an employee of Bristol-Myers Squibb K.K. T. Nekado is an employee of Ono Pharmaceutical Co., Ltd. Y. Shimizu, S. Kariya, T. Fujii, M. Ando, K. Hanyu, H. Hirakawa, T. Ono, D. Sano, M. Yamauchi, A. Watanabe, N. Monden, N. Kudo, M. Arai, S. Yonekura, T. Asakage, and M. Yoshida have nothing to disclose during the conduct of the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}