One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial
Phase 3N = 400NCT00116935
- Population
- Patients with KIT-positive GIST removed at surgery and a high estimated risk of recurrence
- Design
- Randomised (1:1), open-label phase 3 trial in 24 hospitals in Finland, Germany, Norway and Sweden. Imatinib 400 mg per day for 12 or 36 months, started within 12 weeks of surgery. Recurrence risk estimated by the modified NIH consensus criteria.
- Primary endpoint
- RFS
- Arms
- Imatinib 12 months (control, n = 200): Imatinib 400 mg daily for 12 months
- Imatinib 36 months (experimental, n = 200): Imatinib 400 mg daily for 36 months
- People
- Joensuu H, Scandinavian Sarcoma Group
RFSHR 0.46 (95% CI 0.32–0.65)Δ 60-month RFS+17.7 pointsOSHR 0.45 (95% CI 0.22–0.89)Δ 60-month OS+10.3 pointsRFSHR 0.66 (95% CI 0.49–0.87)Δ 60-month RFS+18.4 points
Show the numbers
| Endpoint | Analysis | Imatinib 36 months | Imatinib 12 months | Effect |
|---|---|---|---|---|
| RFSIntention-to-treat population (397 patients) as named in the abstract; the abstract does not state the population for each endpoint separately | primarymedian follow-up 54 monthsJoensuu 2012 | 65.6% at 5 y | 47.9% at 5 y | HR 0.46 (95% CI 0.32–0.65)P<0.001Median follow-up 54 months as of December 2010. 5-year RFS shown for 36 vs 12 months as published. |
| OSIntention-to-treat population (397 patients) as named in the abstract; the abstract does not state the population for each endpoint separately | primarymedian follow-up 54 monthsJoensuu 2012 | 92% at 5 y | 81.7% at 5 y | HR 0.45 (95% CI 0.22–0.89)P=0.02Secondary endpoint. Imatinib discontinued for a reason other than recurrence in 12.6% (12-month group) and 25.8% (36-month group). |
| RFS | long term-updatemedian follow-up 119 monthsJoensuu 2020 | 71.4% at 5 y; 52.5% at 10 y | 53% at 5 y; 41.8% at 10 y | HR 0.66 (95% CI 0.49–0.87)P=0.003Intention-to-treat cohort of 397 patients (12-month group 199, 36-month group 198). The 5-year values differ from the 2012 report (65.6% and 47.9%), whose median follow-up was 54 months. |
| OS | long term-updatemedian follow-up 119 monthsJoensuu 2020 | 92% at 5 y; 79% at 10 y | 85.5% at 5 y; 65.3% at 10 y | HR 0.55 (95% CI 0.37–0.83)P=0.004Intention-to-treat cohort of 397 patients; 96 deaths recorded. |
| Endpoint | Analysis | Imatinib 36 months | Imatinib 12 months | Effect |
|---|---|---|---|---|
| RFSIntention-to-treat population (397 patients) as named in the abstract; the abstract does not state the population for each endpoint separately | primarymedian follow-up 54 monthsJoensuu 2012 | 65.6% at 5 y | 47.9% at 5 y | HR 0.46 (95% CI 0.32–0.65)P<0.001Median follow-up 54 months as of December 2010. 5-year RFS shown for 36 vs 12 months as published. |
| OSIntention-to-treat population (397 patients) as named in the abstract; the abstract does not state the population for each endpoint separately | primarymedian follow-up 54 monthsJoensuu 2012 | 92% at 5 y | 81.7% at 5 y | HR 0.45 (95% CI 0.22–0.89)P=0.02Secondary endpoint. Imatinib discontinued for a reason other than recurrence in 12.6% (12-month group) and 25.8% (36-month group). |
| RFS | long term-updatemedian follow-up 119 monthsJoensuu 2020 | 71.4% at 5 y; 52.5% at 10 y | 53% at 5 y; 41.8% at 10 y | HR 0.66 (95% CI 0.49–0.87)P=0.003Intention-to-treat cohort of 397 patients (12-month group 199, 36-month group 198). The 5-year values differ from the 2012 report (65.6% and 47.9%), whose median follow-up was 54 months. |
| OS | long term-updatemedian follow-up 119 monthsJoensuu 2020 | 92% at 5 y; 79% at 10 y | 85.5% at 5 y; 65.3% at 10 y | HR 0.55 (95% CI 0.37–0.83)P=0.004Intention-to-treat cohort of 397 patients; 96 deaths recorded. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| RFS | 0.46 | 0.32–0.65 |
| OS | 0.45 | 0.22–0.89 |
| RFS | 0.66 | 0.49–0.87 |
| OS | 0.55 | 0.37–0.83 |
- Imatinib 12 months (control)
- Imatinib 36 months (experimental)
Data table (modelled values)
| Months | Imatinib 12 months | Imatinib 36 months |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 32 | 72.6% | 84.1% |
| 65 | 50.8% | 69.5% |
| 97 | 44.5% | 59.3% |
| 130 | 41.8% | 52.5% |
- Imatinib 12 months (control)
- Imatinib 36 months (experimental)
Data table (modelled values)
| Months | Imatinib 12 months | Imatinib 36 months |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 32 | 92.6% | 96.1% |
| 65 | 84.0% | 91.1% |
| 97 | 73.3% | 84.2% |
| 130 | 65.3% | 79.0% |
Appears in
Sources
Joensuu H, Eriksson M, Sundby Hall K, Hartmann JT, Pink D, Schütte J, et al. One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial. JAMA. 2012;307(12):1265-72.
Joensuu H, Eriksson M, Sundby Hall K, Reichardt A, Hermes B, Schütte J, et al. Survival Outcomes Associated With 3 Years vs 1 Year of Adjuvant Imatinib for Patients With High-Risk Gastrointestinal Stromal Tumors: An Analysis of a Randomized Clinical Trial After 10-Year Follow-up. JAMA Oncol. 2020;6(8):1241-1246.