IDEA France
A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy (3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer
Phase 3N = 2,010NCT00958737
- Population
- 2,010 eligible patients (modified intention-to-treat), of whom 2,000 (99 percent) had stage III colon cancer; 1,809 received mFOLFOX6 and 201 CAPOX.
- Design
- Randomised, open-label phase III trial of 3 versus 6 months of mFOLFOX6 or CAPOX (physician's choice) as part of the IDEA collaboration. Primary endpoint disease-free survival; the abstract states that the analyses were descriptive.
- Primary endpoint
- DFS
- Arms
- 3 months (experimental): 3 months of adjuvant oxaliplatin-containing chemotherapy
- 6 months (control): 6 months of adjuvant oxaliplatin-containing chemotherapy
- People
- André T
DFSHR 1.24 (95% CI 1.05–1.46)Δ 36-month DFS−4 pointsDFSHR 1.27 (95% CI 1.07–1.51)Δ 36-month DFS−4 pointsDFSHR 1.44 (95% CI 1.14–1.82)Δ 36-month DFS−8 points
Show the numbers
| Endpoint | Analysis | 3 months | 6 months | Effect |
|---|---|---|---|---|
| DFSModified intention-to-treat population (2,010 eligible patients) | primarymedian follow-up 4.3 yearsAndré 2018 | 72% at 3 y | 76% at 3 y | HR 1.24 (95% CI 1.05–1.46)P=0.0112Rates are given as whole percentages in the abstract. 578 DFS events: 314 in the 3-month arm and 264 in the 6-month arm. The abstract's conclusion is that 6 months was superior in this trial, especially in T4 and/or N2 disease. |
| DFSPatients who received mFOLFOX6 | exploratoryAndré 2018 | 72% at 3 y | 76% at 3 y | HR 1.27 (95% CI 1.07–1.51) |
| DFST4 and/or N2 population | exploratoryAndré 2018 | 58% at 3 y | 66% at 3 y | HR 1.44 (95% CI 1.14–1.82) |
| DFST1-3 N1 population | exploratoryAndré 2018 | 81% at 3 y | 83% at 3 y | HR 1.15 (95% CI 0.89–1.49) |
| Residual neuropathy greater than grade 1Modified intention-to-treat population (2,010 eligible patients) | primaryAndré 2018 | 3% | 7% | P<0.001Maximal grade 2 and grade 3 neuropathy rates were 28 percent and 8 percent in the 3-month arm and 41 percent and 25 percent in the 6-month arm (P < .001). |
| Endpoint | Analysis | 3 months | 6 months | Effect |
|---|---|---|---|---|
| DFSModified intention-to-treat population (2,010 eligible patients) | primarymedian follow-up 4.3 yearsAndré 2018 | 72% at 3 y | 76% at 3 y | HR 1.24 (95% CI 1.05–1.46)P=0.0112Rates are given as whole percentages in the abstract. 578 DFS events: 314 in the 3-month arm and 264 in the 6-month arm. The abstract's conclusion is that 6 months was superior in this trial, especially in T4 and/or N2 disease. |
| DFSPatients who received mFOLFOX6 | exploratoryAndré 2018 | 72% at 3 y | 76% at 3 y | HR 1.27 (95% CI 1.07–1.51) |
| DFST4 and/or N2 population | exploratoryAndré 2018 | 58% at 3 y | 66% at 3 y | HR 1.44 (95% CI 1.14–1.82) |
| DFST1-3 N1 population | exploratoryAndré 2018 | 81% at 3 y | 83% at 3 y | HR 1.15 (95% CI 0.89–1.49) |
| Residual neuropathy greater than grade 1Modified intention-to-treat population (2,010 eligible patients) | primaryAndré 2018 | 3% | 7% | P<0.001Maximal grade 2 and grade 3 neuropathy rates were 28 percent and 8 percent in the 3-month arm and 41 percent and 25 percent in the 6-month arm (P < .001). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 1.24 | 1.05–1.46 |
| DFS | 1.27 | 1.07–1.51 |
| DFS | 1.44 | 1.14–1.82 |
| DFS | 1.15 | 0.89–1.49 |
Appears in
Sources
André T, Vernerey D, Mineur L, Bennouna J, Desrame J, Faroux R, et al. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. J Clin Oncol. 2018;36(15):1469-1477.