| General information |
| Database: | DB00727 |
| Objective: | Bevacizumab significantly improves survival when added to chemotherapy for metastatic colorectal cancer (mCRC). The Bevacizumab Expanded Access Trial (BEAT) evaluated the safety and efficacy of bevacizumab plus firstline chemotherapy in a general cohort of patients with mCRC. |
| Authors: | Van Cutsem E, et al |
| Title: | Safety and efficacy of firstline bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines in metastatic colorectal cancer: the BEAT study. |
| Journal: | Ann Oncol. |
| Year: | 2009 |
| PMID: | 19406901 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | firstline bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines |
| Study Type: | an openlabel, noncomparative trial |
| Key Patients Feature: | patients were included in this openlabel, noncomparative trial if they were>18 years old, had histologically confirmed mCRC and were scheduled tostart firstline fluoropyrimidinebased chemotherapy. Patients had EasternCooperative Oncology Group (ECOG) performance status (PS) of one orless, life expectancy of >3 months and adequate organ function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients with unresectable mCRC received chemotherapy (physician's choice) plus bevacizumab [5 mg/kg every 2 weeks (5fluorouracil regimens) or 7.5 mg/kg every 3 weeks (capecitabine regimens)]. |
| Primary End Point: | safety, including prospective data collection in patients receiving unanticipated surgery during the study |
| Secondary End Point: | progression free survival (PFS) and overall survival (OS) |
| Patients Number: | 1914 |
| Trial Results |
| DLT_MTD: | Serious/grade 3-5 adverse events of interest for bevacizumab includedbleeding (3%), gastrointestinal perforation (2%), arterial thromboembolism (1%), hypertension (5.3%), proteinuria (1%)and woundhealing complications (1%). |
| Objective Response Rate: | Median PFS was 10.8 months [95% confidenceinterval (CI) 10.4-11.3 months] and median OS reached 22.7 months (95% CI 21.7-23.8 months). |
| Disease Control Rate: | NA |
| Median Time to Progression: | In the ITT population, the median TTP was 11.3 months [95% confidence interval (CI) 10.8-11.7 months] |
| Median PFS A vs. C: | 10.8 months [95% confidence interval (CI) 10.4-11.3 months]. 8.6 months (95% CI 8.0-9.8 months) for monotherapy, 11.6 months (95% CI 10.8- 12.5 months) for FOLFIRI, 11.3 months (95% CI 10.3-12.4 months) for FOLFOX and 10.8 months (10.3-12.0 months) for XELOX |
| Median OS A vs. C: | 22.7 months (95% CI 21.7-23.8 months). Median OS was longer for patients receiving doublet regimens (FOLFIRI, 23.7 months (95% CI 21.7-25.9 months); FOLFOX, 25.9 months (95% CI 22.4-28.1 months); XELOX, 23.0 months (95% CI 20.6-26.1 months)] versus monotherapy [18.0 months (95% CI 15.8-20.6 months)] |
| Adverse Event(agent arm): | Serious/grade 3-5 adverse events of interest for bevacizumab included bleeding (3%), gastrointestinal perforation (2%), arterial thromboembolism (1%), hypertension (5.3%), proteinuria (1%) and woundhealing complications (1%). Sixtyday mortality was 3%. |
| Conclusions: | The BEAT study shows that the efficacy and safety profile of bevacizumab in routine clinical practice is consistent with results observed in prospective randomised clinical trials and another large observational study in the United States (BRiTE study). |