{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T12:40:16Z","timestamp":1788871216563,"version":"build-2803163510"},"reference-count":8,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2012,5,29]],"date-time":"2012-05-29T00:00:00Z","timestamp":1338249600000},"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":[[2012,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>On January 31, 2012, the U.S. Food and Drug Administration granted regular approval of imatinib mesylate tablets (Gleevec\u00ae; Novartis Pharmaceuticals Corporation, East Hanover, NJ) for the adjuvant treatment of adult patients following complete gross resection of Kit+ (CD117+) gastrointestinal stromal tumors (GISTs). The recommended dose of imatinib is 400 mg\/day administered daily for 3 years.<\/jats:p>\n                  <jats:p>Three hundred ninety-seven patients were enrolled in a randomized adjuvant, multicenter, open label, phase III trial comparing 12 months with 36 months of imatinib treatment. Eligible patients had one of the following: tumor diameter &amp;gt;5 cm and mitotic count &amp;gt;5 per 50 high power fields (HPFs); tumor diameter &amp;gt;10 cm and any mitotic count; tumor of any size with mitotic count &amp;gt;10\/50 HPFs; or tumor ruptured into the peritoneal cavity. The primary endpoint was the recurrence-free survival (RFS) interval.<\/jats:p>\n                  <jats:p>The median follow-up for patients without an RFS event was 42 months. There were 84 (42%) RFS events in the 12-month treatment arm and 50 (25%) RFS events in the 36-month treatment arm. Thirty-six months of imatinib treatment led to a significantly longer RFS interval than with 12 months of treatment.<\/jats:p>\n                  <jats:p>The median follow-up for overall survival (OS) evaluation in patients still living was 48 months. Thirty-six months of imatinib treatment led to a significantly longer OS time than with 12 months of imatinib treatment.<\/jats:p>\n                  <jats:p>The most common adverse reactions, as noted in previous imatinib studies, were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting, and abdominal pain.<\/jats:p>","DOI":"10.1634\/theoncologist.2012-0109","type":"journal-article","created":{"date-parts":[[2012,5,29]],"date-time":"2012-05-29T22:57:18Z","timestamp":1338332238000},"page":"992-997","source":"Crossref","is-referenced-by-count":16,"title":["Approval Summary: Imatinib Mesylate for One or Three Years in the Adjuvant Treatment of Gastrointestinal Stromal Tumors"],"prefix":"10.1093","volume":"17","author":[{"given":"Martin H.","family":"Cohen","sequence":"first","affiliation":[{"name":"Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Johnson","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Justice","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Pazdur","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 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risk criteria for primary resectable gastrointestinal stromal tumour\u2014the impact of tumour rupture on patient outcomes","volume":"37","author":"Rutkowski","year":"2011","journal-title":"Eur J Surg Oncol"},{"key":"2021122308222940500_B7","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":"2021122308222940500_B8","doi-asserted-by":"crossref","first-page":"679","DOI":"10.1016\/j.humpath.2007.03.001","article-title":"The role of KIT in the management of patients with gastrointestinal stromal tumors","volume":"38","author":"Hornick","year":"2007","journal-title":"Hum Pathol"}],"container-title":["The 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