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Copyright ©2010 Baishideng.
World J Gastroenterol. Jun 14, 2010; 16(22): 2726-2734
Published online Jun 14, 2010. doi: 10.3748/wjg.v16.i22.2726
Table 2 Adjuvant and neoadjuvant trials of imatinib in patients with GISTs
TrialAccrualEligibilityTherapy (n)End points
Phase II study of adjuvant imatinib mesylate in patients with completely resected high-risk primary GIST (ACOSOG-Z9000)ClosedDiameter > 10 cm or tumor rupture or multifocalImatinib 400 mg daily for 1 year (107)2-year OS: 97%, 2-year RFS: 73%[33]
Phase III randomized study of adjuvant imatinib mesylate in patients with resected primary GIST (ACOSOG-Z9001)ClosedDiameter > 3 cmImatinib 400 mg daily for 1 year (359)1-year RFS: 98%[36]
Placebo (354)1-year RFS: 83%
EORTC soft tissue and bone sarcoma group (EORTC-62024) randomized phase III trialClosedDiameter > 5 cm or mitotic rate > 5/50 HPFImatinib 400 mg daily for 2 yearsPrimary: OS
Observation (Total projected 750)Secondary: RFS and safety
Scandinavian sarcoma group trial SSGXVIIIClosedDiameter > 10 cm or mitotic rate > 10/50 HPF or > 5 cm and > 5/50 HPF or tumor ruptureImatinib 400 mg daily for 36 moPrimary: RFS
Imatinib 400 mg daily for 12 mo (Total projected 280)Secondary: OS, safety
Phase II study of neoadjuvant and adjuvant imatinib mesylate in patients with primary or recurrent potentially resectable malignant GIST (RTOG-S0132)ClosedLocally advanced or metastatic/recurrentImatinib 600 mg daily for 6-8 wk followed by debulking/resection (52)2-year PFS: 80%, objective response rate: 6%, R0 resection in 65%[39]
Five year adjuvant imatinib mesylate in GIST (Phase II)OpenDiameter > 2 cm and mitotic rate > 5/50 HPF or non-gastric GIST > 5 cmImatinib 400 mg daily for 5 years (Projected 133)Primary: Time to recurrence
Secondary: Safety
Phase II study of neoadjuvant imatinib mesylate in patients with locally advanced gastrointestinal stromal tumor (Germany/Austria)OpenLocally advanced, KIT expressing, histologically confirmed GISTImatinib 400 mg daily/BID (Projected 40)Primary: ORR Secondary: R0-resectability and organ-preserving resectability