Entry Detail
| General information | |
| Database: | DB00013 |
| Objective: | Elderly patients are often underrepresented in clinical trials of metastatic colorectal cancer. This study aimed to assess the efficacy and safety of bevacizumab plus capecitabine compared with capecitabine alone in elderly patients with metastatic colorectal cancer. |
| Authors: | Cunningham D, et al |
| Title: | Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an openlabel, randomisedphase 3 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2013 |
| PMID: | 24028813 |
| Trial Design | |
| Clinical Trial Id: | NCT00484939 |
| Agent: | bevacizumab |
| Target: | Vascular endothelial growth factor Epidermal growth factor receptor |
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab+capecitabine |
| Study Type: | an openlabel, randomisedphase III trial |
| Key Patients Feature: | patients aged 70 years and older with previously untreated, unresectable, metastatic colorectal cancer, who were not deemed to be candidates for oxaliplatinbased or irinotecanbased chemotherapy regimens with a median age of 76 years (range 7087) were recruited from 40 sites across ten countries. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | capecitabine alone |
| Treatment Info: | patients were randomly assigned in a 1:1 ratio via an interactive voiceresponse system, stratified by performance status and geographical region. Treatment consisted of capecitabine (1000 mg/m(2) orally twice a day on days 114) alone or with bevacizumab (7.5 mg/kg intravenously on day 1), given every 3 weeks until disease progression, unacceptable toxic effects, or withdrawal of consent. Efficacy analyses were based on the intentiontotreat population. |
| Primary End Point: | PFS. |
| Secondary End Point: | safety; confirmed best overall response; the proportion of patients who had an overall response; duration of response; the proportion of patients who achieved disease control; and overall survival. |
| Patients Number: | 280 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | median 9.1 months [95% CI 7.311.4] vs 5.1 months [4.26.3]; hazard ratio 0.53 [0.410.69]; p<0.0001 |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Treatmentrelated adverse events of grade 3 or worse occurred in 53 (40%) patients in the combination group and 30 (22%) in the capecitabine group, and treatmentrelated serious adverse events in 19 (14%) and 11 (8%) patients. The most common grade 3 or worse adverse events of special interest for bevacizumab or chemotherapy were handfoot syndrome (21 [16%] vs nine [7%]), diarrhoea (nine [7%] vs nine [7%]), and venous thromboembolic events (11 [8%] vs six [4%]). Treatmentrelated deaths occurred in five patients in the combination group and four in the capecitabine group. The most common anygrade adverse event of special interest for bevacizumab was haemorrhage (34 [25%] vs nine [7%]). |
| Conclusions: | The combination of bevacizumab and capecitabine is an effective and welltolerated regimen for elderly patients with metastatic colorectal cancer. |