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©The Author(s) 2022.
World J Gastrointest Pathophysiol. Jan 22, 2022; 13(1): 15-33
Published online Jan 22, 2022. doi: 10.4291/wjgp.v13.i1.15
Published online Jan 22, 2022. doi: 10.4291/wjgp.v13.i1.15
Table 3 Clinical studies on adjuvant imatinib
| Trial | ACOSOG Z9001 | SSG XVIII/AIO | EORTC 62024 | PERSIST-5 |
| Study/yr | Phase III/2009 | Phase III/2012, 2020 | Phase III/2015 | Phase II/2018 |
| Number | 359 (total: 713) | 397 (199 vs 198) | 454 (total: 908) | 91 |
| Eligible criteria | Tumor size ≥ 3 cm | High risk group | Intermediate and high-risk group | Intermediate and high-risk group |
| Treatment dose | 400 mg/d | 400 mg/d | 400 mg/d | 400 mg/d |
| Duration | 1 yr vs placebo | 1 yr vs 3 yr | 2 yr vs placebo | 5 yr |
| Risk classification | ||||
| High risk | NA | 178 (89%) | 266 (58.6%) | 67 (74%) |
| Intermediate risk | 15 (8%) | 186 (41%) | 24 (26%) | |
| Etc. | 6 (3%) | 2 (0.4%) | ||
| Residual tumor | ||||
| R0 | 325 (90.5%) | 169 (85%) | 381 (83.9%) | 90 (99%) |
| R1,2 | 34 (9.5%) | 30 (15%) | 73 (16.1%) | 0 (0%) 1; unknown |
| Tumor rupture | ||||
| No | NA | 164 (82%) | 404 (89%) | NA |
| Yes | 35 (18%) | 50 (11%) | ||
| End point | ||||
| Primary endpoint | RFS | RFS | IFFS | RFS |
| Secondary endpoint | OS, safety | RFS, OS, safety | OS | |
| Results | 1-yr RFS; 98% vs 83% (HR = 0.35, P < 0.0001); OS: Not significant | 5-yr RFS; 71% vs 53% (HR = 0.66, P = 0.003); 5-yr OS; 92% vs 86%; 10-yr OS; 79% vs 65% | 5-yr IFFS; 87% vs 84% (HR = 0.79, P = 0.21); 3-yr RFS; 84% vs 66%; 5-yr RFS; 69% vs 63% | 5-yr RFS; 90%; 5-yr OS; 95%; 45 (49%) pts early discontinuation of imatinib |
- Citation: Sugiyama Y, Sasaki M, Kouyama M, Tazaki T, Takahashi S, Nakamitsu A. Current treatment strategies and future perspectives for gastrointestinal stromal tumors. World J Gastrointest Pathophysiol 2022; 13(1): 15-33
- URL: https://www.wjgnet.com/2150-5330/full/v13/i1/15.htm
- DOI: https://dx.doi.org/10.4291/wjgp.v13.i1.15