Updates in oncology
|MedicineWorld.Org: Updates in oncology
Oxaliplatin Based Therapy Combined With Avastin Significantly Improves Survival in Patients With Advanced Colorectal Cancer
- The study, a phase III randomized study of oxaliplatin, fluorouracil, and leucovorin calcium with or without bevacizumab versus bevacizumab alone in patients with previously treated advanced or metastatic colorectal adenocarcinoma also known as 'E3200', was sponsored by the National Cancer Institute and conducted by a network of researchers led by the Eastern Cooperative Oncology Group
- Study Chair Bruce J. Giantonio MD of the University of Pennsylvania Health System
- Additional studies of this combination are ongoing in other colorectal cancer settings
- Preliminary result in 2005 ASCO Gastrointestinal Cancers Symposium, in Hollywood, Florida
- A total of 829 patients were enrolled in the study between October 2001 and April 2003.
- Patients had previously received another chemotherapy combination.
- Patients were randomized to one of three treatment groups. One patient group received the standard FOLFOX4 treatment plus bevacizumab. The second group received the standard FOLFOX4 treatment only, and the third group received bevacizumab alone.
- In March 2003, the study investigators suspended randomization to the third treatment arm, bevacizumab alone, on the recommendation of the Data Monitoring Committee when review of early results suggested that overall survival for patients in that group might be lower than that of patients treated in the other two groups.
- ELOXATIN-based chemotherapy (FOLFOX4) plus bevacizumab (Avastin) will be hereafter referred to regimen A and FOLFOX4 alone will be hereafter referred to regimen B
- Regimen A showed a statistically significant improvement in overall survival compared to regimen B
- Regimen A showed a 26% reduction in the risk of death compared to regimen B
- Regimen A showed median survival of 12.5 months compared to 10.7 months in regimen B
- This difference is statistically significant and corresponds to a 17 percent improvement in median overall survival
- Use of regimen A resulted in 26 percent reduction in the risk of death (hazard ratio of 0.74) compared to regimen B
- Treatment toxicities observed in this study were consistent with those side effects observed in other clinical trials in which bevacizumab was combined with chemotherapy.
- Side effects included neuropathy (nerve toxicity) for FOLFOX4 and high blood pressure and bleeding for bevacizumab.
|MedicineWorl.Org: Updates in oncology
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