New Drug For Advanced Types Of Skin Cancer
A new drug, called vemurafenib (Zelboraf) was released for the treatment of metastatic melanoma. This drug is specifically indicated in patients with melanoma and who have mutations in the BRAF gene. About 50% of patients with melanoma have this type of BRAF mutation, which does not occur in normal cells. This drug is not indicated for use in patients with melanoma and without the BRAF mutation.
Vemurafenib is a BRAF inhibitor that blocks the function of the V600E-mutated BRAF protein. This new drug has been released with a diagnostic test that can help to determine if the patient has melanoma cells with the BRAF V600E mutation.
This is a very important year for patients with advanced melanoma, because Zelboraf is the second new cancer drug that demonstrates an improvement in patient’s survival. In March, was released Yervoy (ipilimumab), another new cancer drug, used for late-stage melanoma that also showed an improvement in patient’s survival. Ipilimumab is an immunotherapeutic agent, which is also indicated for the treatment of metastatic melanoma and unresectable melanoma, unlike vemurafenib, which is used only in patients with advance stages melanoma and BRAF mutation.
The drug was study in clinical trials, in which it was demonstrated that vemurafenib improved overall survival and stop the progression of the disease, compared with standard chemotherapy, in patients with advanced melanoma who did not received previous treatment.
In this clinical trials, was shown that patients who were receiving vemurafenib had a reduction of 74% in the risk for progression of the disease or death, compared with patients who were receiving dacarbazine chemotherapy. Mean progression-free survival was 5.3 months in the vemurafenib group, compared with 1.6 months in the dacarbazine group. At 6 months, estimated survival was 84% in the patients who were treated with vemurafenib and 64% in the patients who were treated with dacarbazine.
In this study, which was conducted at 104 centers in 12 countries, patients who participated had advance forms of melanoma, who were previously untreated or with inoperable stage III or IV metastatic melanoma and a V600E mutation in the BRAF gene. Patients receive either vemurafenib, 960 mg, orally, twice a day or dacarbazine 1000 mg/m2 of body-surface area, in intravenously infusion, every 3 weeks.
Common adverse effects which were associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma, squamous cell carcinoma, photosensitivity, nausea and diarrhea. 38% of the patients required a dose modification because of its toxic effects. Less than 10% of patients who received vemurafenib experienced problems with high levels of toxicity. The most common of these toxic adverse effects were skin rashes, photosensitivity, and joint pain.
The investigators also reported that 12% of patients who were treated with vemurafenib developed advance forms of cutaneous squamous cell carcinoma, compared with less than 1% of the patients who were treated with dacarbazine.