{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T21:09:28Z","timestamp":1791925768853,"version":"4.3.4"},"reference-count":21,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2021,9,14]],"date-time":"2021-09-14T00:00:00Z","timestamp":1631577600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Postmarketing surveillance of Japanese patients with unresectable, previously treated, advanced or recurrent non\u2010small\u2010cell lung cancer treated with nivolumab was undertaken during the conditional approval period. The study aim was to evaluate the occurrence of treatment\u2010related adverse events of nivolumab in the real world. Patients were registered between December 2015 and March 2016 at 536 sites. Nivolumab was given intravenously (3\u00a0mg\/kg every 2\u00a0weeks); the observation period was 12\u00a0months after the first dose of nivolumab. Patients were evaluated for safety (n\u00a0=\u00a03601; 18.2% \u226575\u00a0years, 22.4% ECOG performance status\u00a0\u22652) and effectiveness (n\u00a0=\u00a03570). The frequencies of any grade and grade 3 or higher treatment\u2010related adverse events were 47.1% and 15.9%, respectively. The most frequent treatment\u2010related adverse events (any grade) were interstitial lung disease (6.4%), hypothyroidism (5.7%), and diarrhea (4.4%). Treatment\u2010related adverse events of special interest (priority items) occurring at a frequency of 5% or more were adverse events related to interstitial lung disease, thyroid dysfunction, liver dysfunction, colitis\/severe diarrhea, infusion reaction, and infusion reaction within 24\u00a0hours. Significant risk factors for these priority items were identified by competing risk analysis: interstitial lung disease (previous\/comorbid interstitial lung disease, abnormal findings on chest imaging, and smoking history); liver dysfunction (previous\/comorbid liver disease, smoking history, and metastasis); thyroid dysfunction (previous\/comorbid thyroid disease and performance status); and colitis\/severe diarrhea (treatment line 2 vs \u22653). The 12\u2010month survival rate was 40.7%. In conclusion, the safety profile of nivolumab in this postmarketing surveillance was similar to that in clinical trials, and no new safety signals were identified. The study was registered with the Japan Pharmaceutical Information Center (clinicaltrials.jp: Japic\u2010163271).<\/jats:p>","DOI":"10.1111\/cas.15117","type":"journal-article","created":{"date-parts":[[2021,8,25]],"date-time":"2021-08-25T11:08:03Z","timestamp":1629889683000},"page":"4692-4701","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Real\u2010world safety of nivolumab in patients with non\u2010small\u2010cell lung cancer in Japan: Postmarketing surveillance"],"prefix":"10.1111","volume":"112","author":[{"given":"Nobuyuki","family":"Yamamoto","sequence":"first","affiliation":[{"name":"Wakayama Medical University Wakayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoichi","family":"Nakanishi","sequence":"additional","affiliation":[{"name":"Research Institute for Diseases of the Chest Graduate School of Medicine Kyushu University Fukuoka Japan"},{"name":"Kitakyushu City Hospital Organization Kitakyushu Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiko","family":"Gemma","sequence":"additional","affiliation":[{"name":"Nippon Medical School Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiko","family":"Nakagawa","sequence":"additional","affiliation":[{"name":"Kindai University Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3518-9574","authenticated-orcid":false,"given":"Takahiko","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Ono Pharmaceutical Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayumi","family":"Akamatsu","sequence":"additional","affiliation":[{"name":"Ono Pharmaceutical Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6137-073X","authenticated-orcid":false,"given":"Yuichiro","family":"Ohe","sequence":"additional","affiliation":[{"name":"National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,9,14]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"e_1_2_8_3_1","volume-title":"Global Cancer Observatory: Cancer today","author":"Ferlay J","year":"2018"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/JTO.0000000000000630"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-019-01431-z"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2019.0059"},{"key":"e_1_2_8_7_1","volume-title":"OPDIVO (nivolumab) [package insert]","year":"2021"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1507643"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504627"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.13225"},{"key":"e_1_2_8_11_1","doi-asserted-by":"crossref","first-page":"e000108","DOI":"10.1136\/esmoopen-2016-000108","article-title":"Multicentre phase II study of nivolumab in Japanese patients with advanced or recurrent non\u2010squamous non\u2010small cell lung cancer","volume":"1","author":"Nishio M","year":"2017","journal-title":"ESMO Open"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1999.10474144"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2019.11.014"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-019-00861-y"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.14715"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.21037\/tlcr.2018.04.03"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2018-0737"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2017.3064"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.31200"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1089\/thy.2013.0241"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2019.05.010"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1080\/2162402X.2020.1744898"}],"container-title":["Cancer Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15117","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cas.15117","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15117","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T22:07:08Z","timestamp":1692655628000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cas.15117"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,14]]},"references-count":21,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2021,11]]}},"alternative-id":["10.1111\/cas.15117"],"URL":"https:\/\/doi.org\/10.1111\/cas.15117","archive":["Portico"],"relation":{},"ISSN":["1347-9032","1349-7006"],"issn-type":[{"value":"1347-9032","type":"print"},{"value":"1349-7006","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,14]]},"assertion":[{"value":"2021-05-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-08-21","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-09-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}