Table 3.
Summary of Studies Evaluating the Efficacy of Imatinib for the Postsurgical Adjuvant Treatment of Patients With Resectable Gastrointestinal Stromal Tumors
| Study and Design | Treatment | Patientsa | Efficacy |
|---|---|---|---|
| ACOSOG Z9001 trial (Dematteo 200928); phase 3, R, DB, ongoing study | Im 400 mg/d × 1 y vs Plb | Tumor size ≥3 cm; N=713 (evaluable)c | RFS (primary endpoint): 1 y, Im 98% vs Pl 83% (P = .0001; HR, 0.35; 95% CI, 0.22–0.53); OS: no significant difference between Im or Pl |
| ACOSOG Z9000 trial (Dematteo 200829); phase 2, MC, OL | Im 400 mg/d × 1 yr | High-risk relapse (tumor size ≥10 cm, tumor rupture, or <5 peritoneal metastases); N=107 (evaluable) | OS (primary endpoint): 1 y 99%, 2 y 97%, 3 y 97%; RFS: 2 y 94%, 2 y 73%, 3 y 61% |
| MC, OL (Zhan 200730) | Im 400 mg/d × ≥1 y | High-risk relapse (tumor size ≥5 cm or ≥5/50 HPF); N=51 (evaluable) | Relapse or metastases rate (primary endpoint): 3.92% of patients; median DFS, 385 d |
| EORTC 62024 (EORTC 200931); ongoing phase 3, MC, R, OL | Im 400 mg/d × 2 y vs no further treatment | High-risk relapse (tumor >10 cm or mitotic rate >10/50 HPF or tumor >5 cm AND mitotic rate >5/50 HPF) or intermediate-risk of relapse (tumor <5 cm AND mitotic rate 6–10/50 HPF or tumor 5–10 cm AND mitotic rate <5/50 HPF) | Time to secondary resistance (primary endpoint): results awaited |
| SSG XVIII/AIO (SGS 200932); ongoing phase 3, MC, R, OL | Im 400 mg/d × 1 y or 3 y | High-risk relapse (tumor >10 cm or mitotic rate >10/50 HPF or tumor >5 cm AND mitotic rate >5/50 HPF) | RFS (primary endpoint): results awaited |
ACOSOG indicates American College of Surgeons Oncology Group; R, randomized; DB, double blind; Im, imatinib; Pl, placebo; RFS, recurrence-free survival; HR, hazard ratio; CI, confidence interval; OS, overall survival; MC, multicenter; OL, open label; HPF, high-power fields; DFS, disease-free survival; EORTC, European Organization for Research and Treatment of Cancer; SGS, Scandinavian Sarcoma Group; XVIII/AIO, Scandinavian and German Intergroup Trial.
All patients underwent a complete resection of v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT)-positive tumor.
Upon recurrence, treatment was unblinded, and patients were crossed over to Im if they were receiving Pl or the Im dose was increased to 800 mg/day if they already were receiving Im.
Patients to be followed for up to 10 years.