AVANT
Bevacizumab plus oxaliplatin-based chemotherapy as adjuvant treatment for colon cancer (AVANT): a phase 3 randomised controlled trial
Phase 3N = 3,451NCT00112918
- Population
- 3451 patients in the intention-to-treat population, of whom 2867 had stage III disease (primary analysis population) and 573 had high-risk stage II disease (safety analysis only).
- Design
- Open-label, three-arm phase 3 trial at 330 centres in 34 countries in resected stage III or high-risk stage II colon cancer: FOLFOX4 for 12 cycles, bevacizumab plus FOLFOX4 followed by bevacizumab monotherapy, or bevacizumab plus XELOX followed by bevacizumab monotherapy (1:1:1). Primary endpoint disease-free survival in stage III patients.
- Primary endpoint
- DFS
- Arms
- FOLFOX4 (control, n = 955): FOLFOX4 every 2 weeks for 12 cycles
- Bevacizumab plus FOLFOX4 (experimental, n = 960): Bevacizumab 5 mg/kg plus FOLFOX4 every 2 weeks for 12 cycles followed by bevacizumab 7.5 mg/kg every 3 weeks for eight cycles
- Bevacizumab plus XELOX (experimental, n = 952): Bevacizumab 7.5 mg/kg plus XELOX every 3 weeks for eight cycles followed by bevacizumab 7.5 mg/kg every 3 weeks for eight cycles
- People
- de Gramont A
DFSHR 1.17 (95% CI 0.98–1.39)DFSHR 1.07 (95% CI 0.90–1.28)OSHR 1.27 (95% CI 1.03–1.57)OSHR 1.15 (95% CI 0.93–1.42)
Show the numbers
| Endpoint | Analysis | Bevacizumab plus FOLFOX4 / Bevacizumab plus XELOX | FOLFOX4 | Effect |
|---|---|---|---|---|
| DFSPatients with stage III disease (2,867 randomised) | primarymedian follow-up 48 monthsde 2012 | — | — | HR 1.17 (95% CI 0.98–1.39)P=0.07Comparison of bevacizumab-FOLFOX4 with FOLFOX4. Events: 237 (25 percent), 280 (29 percent) and 253 (27 percent) in the FOLFOX4, bevacizumab-FOLFOX4 and bevacizumab-XELOX groups. Serious adverse events: 297 (26 percent), 284 (25 percent) and 226 (20 percent) in the bevacizumab-FOLFOX4, bevacizumab-XELOX and FOLFOX4 groups. |
| DFSPatients with stage III disease (2,867 randomised) | primarymedian follow-up 48 monthsde 2012 | — | — | HR 1.07 (95% CI 0.90–1.28)P=0.44Comparison of bevacizumab-XELOX with FOLFOX4. |
| OSPatients with stage III disease (2,867 randomised) | long term-updatede 2012 | — | — | HR 1.27 (95% CI 1.03–1.57)P=0.02Minimum follow-up 60 months. The authors state that overall survival data suggest a potential detrimental effect with bevacizumab plus oxaliplatin-based adjuvant therapy. |
| OSPatients with stage III disease (2,867 randomised) | long term-updatede 2012 | — | — | HR 1.15 (95% CI 0.93–1.42)P=0.21Minimum follow-up 60 months. |
| Endpoint | Analysis | Bevacizumab plus FOLFOX4 / Bevacizumab plus XELOX | FOLFOX4 | Effect |
|---|---|---|---|---|
| DFSPatients with stage III disease (2,867 randomised) | primarymedian follow-up 48 monthsde 2012 | — | — | HR 1.17 (95% CI 0.98–1.39)P=0.07Comparison of bevacizumab-FOLFOX4 with FOLFOX4. Events: 237 (25 percent), 280 (29 percent) and 253 (27 percent) in the FOLFOX4, bevacizumab-FOLFOX4 and bevacizumab-XELOX groups. Serious adverse events: 297 (26 percent), 284 (25 percent) and 226 (20 percent) in the bevacizumab-FOLFOX4, bevacizumab-XELOX and FOLFOX4 groups. |
| DFSPatients with stage III disease (2,867 randomised) | primarymedian follow-up 48 monthsde 2012 | — | — | HR 1.07 (95% CI 0.90–1.28)P=0.44Comparison of bevacizumab-XELOX with FOLFOX4. |
| OSPatients with stage III disease (2,867 randomised) | long term-updatede 2012 | — | — | HR 1.27 (95% CI 1.03–1.57)P=0.02Minimum follow-up 60 months. The authors state that overall survival data suggest a potential detrimental effect with bevacizumab plus oxaliplatin-based adjuvant therapy. |
| OSPatients with stage III disease (2,867 randomised) | long term-updatede 2012 | — | — | HR 1.15 (95% CI 0.93–1.42)P=0.21Minimum follow-up 60 months. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 1.17 | 0.98–1.39 |
| DFS | 1.07 | 0.9–1.28 |
| OS | 1.27 | 1.03–1.57 |
| OS | 1.15 | 0.93–1.42 |