{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T21:56:29Z","timestamp":1774994189882,"version":"3.50.1"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2010,3,1]],"date-time":"2010-03-01T00:00:00Z","timestamp":1267401600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2010,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>On December 19, 2008, the U.S. Food and Drug Administration approved imatinib mesylate tablets for oral use (Gleevec\u00ae; Novartis Pharmaceuticals Corporation, East Hanover, NJ) for the adjuvant treatment of adult patients following complete gross resection of Kit+ (CD117+) gastrointestinal stromal tumor (GIST).<\/jats:p>\n               <jats:p>A randomized, double-blind, placebo-controlled study enrolling 713 patients was submitted. The primary objective of the clinical trial was to compare the recurrence-free survival (RFS) intervals of the two groups. Overall survival (OS) was a secondary endpoint. Eligible patients were \u226518 years of age with a histological diagnosis of GIST (Kit+), resected tumor size \u22653 cm, and a complete gross resection within 14\u201370 days prior to registration. Imatinib, 400 mg orally, was administered once daily for 1 year.<\/jats:p>\n               <jats:p>The study was terminated after completion of the third protocol-specified interim analysis. At that time, 100 RFS events were confirmed by a blinded central independent review. With a median follow-up of 14 months, 30 RFS events were observed in the imatinib group and 70 were observed in the placebo group (hazard ratio, 0.398; 95% confidence interval, 0.259\u20130.610; two-sided p-value &amp;lt; .0001). OS results are immature.<\/jats:p>\n               <jats:p>Most patients in both groups experienced at least one adverse reaction, and 31% of the imatinib group and 18% of the placebo group experienced grade \u22653 adverse reactions. The most frequently reported adverse reactions (\u226520%) were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting, and abdominal pain. Drug was discontinued for adverse reactions in 17% and 3% of the imatinib and placebo-treated patients, respectively.<\/jats:p>","DOI":"10.1634\/theoncologist.2009-0120","type":"journal-article","created":{"date-parts":[[2010,3,4]],"date-time":"2010-03-04T01:33:53Z","timestamp":1267666433000},"page":"300-307","source":"Crossref","is-referenced-by-count":34,"title":["Approval Summary: Imatinib Mesylate in the Adjuvant Treatment of Malignant Gastrointestinal Stromal Tumors"],"prefix":"10.1093","volume":"15","author":[{"given":"Martin H.","family":"Cohen","sequence":"first","affiliation":[{"name":"Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Cortazar","sequence":"additional","affiliation":[{"name":"Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver 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mutations in gastrointestinal stromal tumors: Frequency, spectrum and in vitro sensitivity to imatinib","volume":"23","author":"Corless","year":"2005","journal-title":"J Clin Oncol"},{"key":"2021122207265386000_R11","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1111\/j.1365-2559.2008.02977.x","article-title":"Clinical significance of oncogenic KIT and PDGFRA mutations in gastrointestinal stromal tumours","volume":"53","author":"Lasota","year":"2008","journal-title":"Histopathology"},{"key":"2021122207265386000_R12","doi-asserted-by":"crossref","first-page":"1411","DOI":"10.1016\/j.humpath.2008.06.025","article-title":"Risk stratification of patients diagnosed with gastrointestinal stromal tumor","volume":"39","author":"Joensuu","year":"2008","journal-title":"Hum Pathol"},{"key":"2021122207265386000_R13","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1097\/01.pas.0000146010.92933.de","article-title":"Gastrointestinal stromal tumors of the stomach: A 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