Table 2.
Ref.
|
Clinical trial
|
Yr
|
Design
|
Endpoint
|
Cases
|
Agent/Dose
|
Patients
|
Duration
|
RR
|
R0 rate
|
Adjuvant imatinib
|
PFS
|
OS
|
Prospective study | |||||||||||||
Eisenberg et al[39] | RTOG0132 trial | 2009 | Phase II | RFS | 30 (all; 52) | Imatinib/600 mg | GIST (> 5 cm) | 8-12 wk | 7% | 77% | 24 mo | 2-yr PFS; 83% | 2-yr OS; 93% |
Wang et al[40] | RTOG0132 (long follow up) | 2012 | 31 (all; 53) | 5-yr PFS; 57% | 5-yr OS; 77% | ||||||||
Doyon et al[41] | 2012 | Phase II | RR | 14 | Imatinib/400 mg | Locally advanced GIST | 6 mo | 43% | 79% | 12 mo | 4-yr DFS; 64% | 4-yr OS; 100% | |
Kurokawa et al[42] | Asia | 2017 | Phase II | PFS | 53 | Imatinib/400 mg | Gastric GIST (> 10 cm) | 6-9 mo | 62% | 91% | 36 mo | 2-yr PFS; 89% | 2-yr OS; 98% |
Retrospective study | |||||||||||||
Blesius et al[35] | BFR14 trial | 2011 | Subset phase III | - | 25 | Imatinib/400 mg | Locally advanced GIST | 4.2 mo (median) | 60% | 32% | 13-24 mo | 3-yr PFS; 67% | 3-yr OS; 89% |
Rutkowski et al[36] | EORTC | 2012 | Database | - | 161 | Imatinib/400 mg | Locally advanced GIST | 40 wk (median) | 80% | 83% | At least 1 yr (56%) | 5-yr DFS; 65% | 5-yr DSS; 95% |
Tielen et al[37] | 2013 | Database | PFS/OS | 57 | Imatinib/400 mg | GIST (> 5 cm) and/or ill-located for surgery | 8 mo (median) | 83% | 84% | 1, 2 yr or lifelong (58%) | 5-yr PFS; 77% | 5-yr OS; 88% |
RFS: Relapse-free survival; RR: Response rate; PFS: Progression-free survival; OS: Overall survival; DSS: Disease-specific survival.