Entry Detail
| General information | |
| Database: | DB00014 |
| Objective: | To determine whether adding bevacizumab, with or without mitomycin, to capecitabine monotherapy improves progression free survival (PFS) in patients with metastatic colorectal cancer (mCRC) in an openlabel, threearm randomized trial. |
| Authors: | Tebbutt NC, et al |
| Title: | Capecitabine, bevacizumab, and mitomycin in firstline treatment of metastatic colorectal cancer: results of the Australasian Gastrointestinal Trials Group Randomizedphase III MAX Study. |
| Journal: | J Clin Oncol |
| Year: | 2010 |
| PMID: | 20516443 |
| Trial Design | |
| Clinical Trial Id: | ACTRN12605000025639 |
| 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: | capecitabine+bevacizumab (CB); or capecitabine+bevacizumab+ mitomycin (CBM) |
| Study Type: | a randomizedphase III MAX threearm Study |
| Key Patients Feature: | patients in Australia, New Zealand, and the United Kingdom with previously untreated, unresectable mCRC |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | 3 arm: capecitabine vs capecitabine+bevacizumab (CB) vs capecitabine, bevacizumab, and mitomycin (CBM) |
| Treatment Info: | patients were randomly assigned to the following: capecitabine; capecitabine plus bevacizumab (CB); or capecitabine, bevacizumab, and mitomycin (CBM). |
| Primary End Point: | primary: compared CB with capecitabine and CBM with capecitabine for progression free survival (PFS). |
| Secondary End Point: | Secondary: overall survival (OS), toxicity, response rate (RR), and quality of life (QOL). |
| Patients Number: | 471 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.7 ms for capecitabine, 8.5 ms for CB, and 8.4 ms for CBM (capecitabine v CB: [HR], 0.63; 95% CI, 0.50 to 0.79; P < .001; C v CBM: HR, 0.59; 95% CI, 0.47 to 0.75; P < .001). |
| Median OS A vs. C: | 18.9 months for capecitabine and was 16.4 months for CBM; these data were not significantly different. |
| Adverse Event(agent arm): | Toxicity rates were acceptable, and all treatment regimens well tolerated. Bevacizumab toxicities were similar to those in previous studies. Measures of overall QOL were similar in all groups. |
| Conclusions: | Adding bevacizumab to capecitabine, with or without mitomycin, significantly improves PFS without major additional toxicity or impairment of QOL. |