Info
🌱 來自: Metastatic Colon Cancer
ML18147
- Design:
- Phase 3 trial
- Multi-center
- Randomized
- Open-label
- Number of patients: 820 patients
- 409 patients in the bevacizumab plus chemotherapy group
- 411 patients in the chemotherapy alone group
- Patients characteristics:
- Patients aged ≥18 years with unresectable, histologically confirmed metastatic colorectal cancer progressing up to 3 months after discontinuing first-line bevacizumab plus chemotherapy
- Agent:
- Bevacizumab plus standard second-line chemotherapy
- Treatment line:
- Second-line chemotherapy with or without bevacizumab
- Trial Name or NCT Number: NCT00700102
- Comparison of two groups:
| Outcome | Bevacizumab plus chemotherapy group | Chemotherapy alone group |
|---|---|---|
| Median overall survival (months) | 11.2 (95% CI 10.4-12.2) | 9.8 (95% CI 8.9-10.7) |
| Hazard ratio | 0.81 | 95% CI 0.69-0.94 |
| Unstratified log-rank test p-value | 0.0062 | not reported |
| Grade 3-5 bleeding or haemorrhage | 8 (2%) | 1 (<1%) |
| Gastrointestinal perforation | 7 (2%) | 3 (<1%) |
| Venous thromboembolisms | 19 (5%) | 12 (3%) |
| Neutropenia | 65 (16%) | 52 (13%) |
| Diarrhoea | 40 (10%) | 34 (8%) |
| Asthenia | 23 (6%) | 17 (4%) |
| Treatment-related deaths | 4 | 3 |