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
Published online Jun 14, 2010. doi: 10.3748/wjg.v16.i22.2726
Table 2 Adjuvant and neoadjuvant trials of imatinib in patients with GISTs
Trial | Accrual | Eligibility | Therapy (n) | End points |
Phase II study of adjuvant imatinib mesylate in patients with completely resected high-risk primary GIST (ACOSOG-Z9000) | Closed | Diameter > 10 cm or tumor rupture or multifocal | Imatinib 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) | Closed | Diameter > 3 cm | Imatinib 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 trial | Closed | Diameter > 5 cm or mitotic rate > 5/50 HPF | Imatinib 400 mg daily for 2 years | Primary: OS |
Observation (Total projected 750) | Secondary: RFS and safety | |||
Scandinavian sarcoma group trial SSGXVIII | Closed | Diameter > 10 cm or mitotic rate > 10/50 HPF or > 5 cm and > 5/50 HPF or tumor rupture | Imatinib 400 mg daily for 36 mo | Primary: 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) | Closed | Locally advanced or metastatic/recurrent | Imatinib 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) | Open | Diameter > 2 cm and mitotic rate > 5/50 HPF or non-gastric GIST > 5 cm | Imatinib 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) | Open | Locally advanced, KIT expressing, histologically confirmed GIST | Imatinib 400 mg daily/BID (Projected 40) | Primary: ORR Secondary: R0-resectability and organ-preserving resectability |
- Citation: Bayraktar UD, Bayraktar S, Rocha-Lima CM. Molecular basis and management of gastrointestinal stromal tumors. World J Gastroenterol 2010; 16(22): 2726-2734
- URL: https://www.wjgnet.com/1007-9327/full/v16/i22/2726.htm
- DOI: https://dx.doi.org/10.3748/wjg.v16.i22.2726