{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T23:04:24Z","timestamp":1791673464043,"version":"4.3.4"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T00:00:00Z","timestamp":1737590400000},"content-version":"vor","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen Inc","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,1,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>We describe the safety of sotorasib monotherapy in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) and discuss practical recommendations for managing key risks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Incidence rates of treatment-related adverse events (TRAEs) were pooled from 4 clinical trials: CodeBreaK 100 (NCT03600883), CodeBreaK 101 (NCT04185883), CodeBreaK 105 (NCT04380753), and CodeBreaK 200 (NCT04303780) and graded according to CTCAE v5.0. Adverse events were deemed sotorasib-related per investigator causality assessment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the pooled population (n\u2005=\u2005549), TRAEs were reported in 388 (70.7%) patients (grade 1: 124 [22.6%]; grade 2: 117 [21.3%]; grade\u2005\u2265\u20053: 147 [26.8%]). Gastrointestinal and hepatic TRAEs, including diarrhea (171 [31.1%]), nausea (80 [14.6%]), elevated alanine aminotransferase (ALT;\u00a068 [12.4%]), and elevated aspartate aminotransferase (AST; 67 [12.2%]) were the most common (\u226510%). Dose interruption and dose reduction of sotorasib resulted in the resolution of &amp;gt;90% of diarrhea events; median time to resolution were 18.0 days and 22.0 days, respectively. Similar trends were observed for elevated ALT and AST events. Patients who stopped immunotherapy &amp;lt;3 months before initiating sotorasib had a higher incidence of treatment-related hepatotoxicity (80\/240 [33.3%]) than those who stopped immunotherapy \u22653 months before initiating sotorasib (26\/188 [13.8%]). Treatment-related pneumonitis\/interstitial lung disease (ILD) and corrected QT (QTc) prolongation were observed in 9 (1.6%) and 4 (0.7%) patients, respectively. Two (0.4%) patients died with TRAEs, 1 with ILD whose ultimate cause of death was disease progression, and the other with an unknown cause.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Sotorasib has a well-characterized safety profile in patients with KRAS G12C-mutated advanced NSCLC, and key risks are manageable with dose modification.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyae356","type":"journal-article","created":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T15:15:40Z","timestamp":1737645340000},"source":"Crossref","is-referenced-by-count":16,"title":["Pooled safety analysis and management of sotorasib-related adverse events in <i>KRAS<\/i> G12C-mutated advanced non-small cell lung cancer"],"prefix":"10.1093","volume":"30","author":[{"given":"Ferdinandos","family":"Skoulidis","sequence":"first","affiliation":[{"name":"Department of Thoracic\/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX 77030 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bob T","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Memorial Sloan Kettering Cancer Center , New York, NY 10065 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Hochmair","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf , 1210\u00a0Vienna ,","place":["Austria"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramaswamy","family":"Govindan","sequence":"additional","affiliation":[{"name":"Division of Oncology, Department of Internal Medicine, Washington University School of Medicine , St. Louis, MO 63110 ,","place":["United 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J","family":"O\u2019Byrne","sequence":"additional","affiliation":[{"name":"Faculty of Health, Queensland University of Technology , Brisbane, QLD 4000 ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9909-2299","authenticated-orcid":false,"given":"Nicolas","family":"Girard","sequence":"additional","affiliation":[{"name":"Institut du Thorax Curie-Montsouris, Institut Curie , 75014\u00a0Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Griesinger","sequence":"additional","affiliation":[{"name":"Pius-Hospital Oldenburg, Department of Haematology and Oncology, University Department Internal Medicine-Oncology, University Medicine Oldenburg , 26121\u00a0Oldenburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Nishio","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research , Tokyo 135-8550 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"H\u00e4fliger","sequence":"additional","affiliation":[{"name":"Inselspital, Bern University Hospital, University of Bern , 3010\u00a0Bern ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin","family":"Lindsay","sequence":"additional","affiliation":[{"name":"Division of Cancer Sciences, University of Manchester , Manchester M13 9PL ,","place":["United Kingdom"]},{"name":"The Christie NHS Foundation Trust , Manchester M20 4BX ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels","family":"Reinmuth","sequence":"additional","affiliation":[{"name":"Department of Oncology, Asklepios Lung Clinic, German Center for Lung Research , Munich-Gauting, 82131 Gauting 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