In a nutshell
This study compared the effects of vemurafenib (Zelboraf) and dacarbazine on clinical outcomes in patients with BRAF-v600E or BRAF-v600K mutation-positive melanoma.
Some background
A mutated BRAF protein, important in directing cell growth, is believed to be responsible for 40% to 60% of all melanomas. Mutations in genes encoding for this protein (such as BRAF-v600E and BRAF-v600K) may lead to aggressive cell growth and cancer spread. Vemurafenib, a BRAF inhibitor, is therefore often used to treat patients with BRAF-mutated melanomas.
A recent phase III study has demonstrated the improved efficiency of vemurafenib compared to the standard chemotherapy agent dacarbazine. This analysis provides an extended follow-up on the clinical outcomes of patients treated in the original phase III trial, with special emphasis on BRAF-v600E and BRAF-v600K patient subgroup.
Methods & findings
The study enrolled 675 patients with BRAF mutation-positive metastatic melanoma. 337 patients were randomly assigned to receive vemurafenib and 338 patients were assigned to receive dacarbazine. Outcomes were analyzed after an average follow-up of 12.5 months for patients receiving vemurafenib, and 9.5 months for patients receiving dacarbazine.
Overall survival was significantly longer for patients receiving vemurafenib compared to those receiving dacarbazine (13.6 months versus 9.7 months). Further analysis showed similar results for both BRAF-v600E mutated patients and BRAF-v600K mutated patients. In both subgroups, patients treated with vemurafenib demonstrated longer overall survival than patients treated with dacarbazine.
The bottom line
This study concluded that vemurafenib significantly improves survival compared to standard chemotherapy in patients with both BRAF-v600E and BRAF-v600K mutation-positive advanced melanoma.
Published By :
Lancet oncology
Date :
Feb 06, 2014
