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Long-term results of adjuvant imatinib mesylate in localized, high risk, primary gastrointestinal stromal tumor (GIST): The American College of Surgeons Oncology Group (ACOSOG) Z9000 trial
Ronald P DeMatteo1, Karla Ballman*2, Cristina Antonescu*1, Christopher Corless*3, Violetta Kolesnikova*3, Margaret von Mehren*4, Martin McCarter*5, Jeffrey Norton6, Robert Maki*7, Peter WT Pisters8, George Demetri*9, Murray F. Brennan1, Kouros Owzar*10
1Memorial Sloan-Kettering Cancer Center, New York, NY;2Mayo Clinic, Rochester, MN;3Oregon Health Sciences University, Portland, OR;4Fox Chase Cancer Center, Philadelphia, PA;5University of Colorado Denver School of Medicine, Denver, CO;6Stanford University School of Medicine, Stanford, CA;7Mount Sinai School of Medicine, New York, NY;8University of Texas MD Anderson Cancer Center, Houston, TX;9Dana Farber Cancer Institute, Boston, MA;10Duke University, Durham, NC

OBJECTIVE(S): GIST is the most common sarcoma. Surgery is the mainstay for primary GIST, but tumor recurrence is common. GIST typically contains a KIT or PDGFRA mutation and imatinib mesylate (Gleevec) inhibits both associated proteins. We tested whether adjuvant imatinib prolongs overall survival (OS) in GIST.
METHODS: We conducted the first adjuvant trial of imatinib in GIST. From 09/2001 to 09/2003, we accrued 106 patients with primary GIST at high risk for postoperative recurrence [size >10 cm (85%), tumor rupture (17%), or <4 peritoneal implants (13%)]. Patients were prescribed imatinib 400 mg/day for 1 year and followed with serial CT or MRI exams for 5 years. The primary endpoint was OS compared to a 5 year historical value of 35%.
RESULTS: After a median follow up of 7.7 years, the 1, 3, and 5 year OS was 99, 97, and 83%. The 1, 3, and 5 year recurrence-free survival (RFS) was 96, 60, and 40%. On univariable analysis, higher age and mitotic rate were associated with poor OS. On multivariable analysis, RFS was lower with increasing tumor size, small bowel site, KIT exon 9 mutation, high mitotic rate, and older age. There were no grade 4 or 5 adverse events and 26% had grade 3 toxicity. CONCLUSIONS: Adjuvant imatinib in patients with primary GIST who are at high risk of recurrence prolonged OS compared to that of historical controls. Tumor size, site, mutation type, mitotic rate, and age were associated with RFS. The optimal duration of adjuvant therapy remains undefined.


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