{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T21:43:54Z","timestamp":1791150234938,"version":"4.1.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2022,3,23]],"date-time":"2022-03-23T00:00:00Z","timestamp":1647993600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Chugai Pharmaceutical Co., Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,31]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>We conducted a post-marketing surveillance study to evaluate the clinical tolerability and safety of atezolizumab in Japanese patients with non-small-cell lung cancer (NSCLC).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This prospective, observational post-marketing cohort study was conducted in NSCLC patients who received atezolizumab 1200\u00a0mg every 3\u00a0weeks at 770 facilities in Japan between April 18, 2018, and March 31, 2020 (study number UMIN000031978). Case report forms were completed, recording patient characteristics, treatment details, adverse events, adverse drug reactions (ADRs), their severity, onset and outcomes. Follow-up was for 12\u00a0months or until atezolizumab discontinuation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 2570 patients were included, median age was 69.0\u00a0years, and 69.9% were males. ADRs were reported in 29.1% of patients, most commonly pyrexia (4.2%). Grade\u00a0\u2265\u00a03 ADRs occurred in 9.7% of patients aged &amp;lt;75 and 9.7% of those aged \u226575\u00a0years. The incidence of Grade\u00a0\u2265\u00a03 ADRs was not affected by the number of lines of previous treatment or the presence or history of an autoimmune disorder. Immune-related ADRs of interest that occurred in &amp;gt;1% of patients were interstitial lung disease (ILD; 4.4%), endocrine disorder (4.3%), and hepatic dysfunction (2.8%). ILD was significantly more common in patients with a history of, or concurrent, ILD versus those without (P\u00a0\u2264\u00a00.001). Risk factors of Grade\u00a0\u2265\u00a03 ADRs were a history of, or concurrent, ILD. Grade 5 ADRs occurred in 35 patients, 11 of whom had concurrent ILD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This large cohort study confirmed the clinical tolerability of atezolizumab in a real-world group of Japanese patients with NSCLC.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyac024","type":"journal-article","created":{"date-parts":[[2022,2,15]],"date-time":"2022-02-15T13:40:34Z","timestamp":1644932434000},"page":"623-632","source":"Crossref","is-referenced-by-count":10,"title":["The real-world safety of atezolizumab as second-line or later treatment in Japanese patients with non-small-cell lung cancer: a post-marketing surveillance study"],"prefix":"10.1093","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6137-073X","authenticated-orcid":false,"given":"Yuichiro","family":"Ohe","sequence":"first","affiliation":[{"name":"Department of Thoracic Oncology , , Tokyo, Japan"},{"name":"National Cancer Center Hospital , , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9638-0428","authenticated-orcid":false,"given":"Naoya","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Department of Dermatologic Oncology , , Tokyo, Japan"},{"name":"National Cancer Center Hospital , , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuyuki","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Internal Medicine III , , Wakayama, Japan"},{"name":"Wakayama Medical University , , Wakayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haruyasu","family":"Murakami","sequence":"additional","affiliation":[{"name":"Division of Thoracic Oncology , , Sunto-gun, Japan"},{"name":"Shizuoka Cancer Center , , Sunto-gun, 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