In a nutshell
This phase 3 clinical trial compared the safety and efficacy of dabrafenib to a standard treatment for melanoma, dacarbazine in patients with metastatic melanoma.
Some background
BRAF is a protein that helps cells grow and multiply. A genetic defect can cause the BRAF protein to malfunction (BRAF mutation). A BRAF mutation is present in about 50% of melanomas, so BRAF mutations are responsible for the rapid growth of melanomas. Certain drugs can target the BRAF protein and block its action (targeted therapies), thus stopping the uncontrolled growth of BRAF-mutated melanomas. A standard treatment for melanoma is the chemotherapy drug dacarbazine. However, new targeted therapies show promise in treating patients with metastatic melanoma. Dabrafenib (Tafinlar) is a new targeted therapy drug that has just been approved by the U.S. FDA for the treatment of patients with metastatic melanoma. The authors of this study evaluated the benefits of dabrafenib compared to standard therapy with dacarbazine in patients with metastatic melanoma.
Methods & findings
Researchers recruited 250 metastatic melanoma patients with specific BRAF mutations, called BRAFV600E. Of these, 187 received dabrafenib and 63 received dacarbazine. Progression-free survival (the percentage of patients who have survived for a defined period of time, without progression of their cancer) in patients who received dabrafenib was almost double than in those treated with dacarbazine (5.1 months versus 2.7 months). After their melanoma progressed, 24 of 63 dacarbazine patients switched to dabrafenib and half of those patients' cancers responded to the new drug. Side effects were more common in the dabrafenib group (53%) than in the dacarbazine group (44%). The most common side effects to dabrafenib therapy were skin reactions, fever, joint pain or headache. Patients treated with dacarbazine reported side effects such as nausea, vomiting or tiredness.
The bottom line
In this study, dabrafenib slowed cancer growth in patients with BRAF-mutated metastatic melanoma. Furthermore, it resulted in longer progression-free survival compared to treatment with dacarbazine.
The fine print
This study was sponsored by GlaxoSmithKline, the manufacturer of Tafinlar.
This study served as grounds for the FDA approval of dabrafenib in patients with metastatic melanoma.
What’s next?
Ask your doctor if treatment with dabrafenib is appropriate for your situation.
Published By :
The Lancet
Date :
Jun 25, 2012
