Combination treatment regimen not effective against advanced melanoma

"With each new study, we learn something important about the treatment of melanoma," said John M. Kirkwood, M.D., professor of medicine, University of Pittsburgh School of Medicine, and leader of the University of Pittsburgh Cancer Institute's (UPCI) melanoma and skin cancer program. "With this study, we learned that the addition of sorafenib, a molecular inhibitor, to a traditional chemotherapy regimen does not improve patient survival."

The phase III trial, which was sponsored by the Eastern Cooperative Oncology Group (ECOG), enrolled 823 patients from seven different sites across the country over 34 months. The primary goal of the study was to determine whether the addition of sorafenib, a molecular targeting agent, would improve survival rates for patients with metastatic melanoma when added to the chemotherapy combination of carboplatin and paclitaxel. Patients either received the chemotherapy combination alone or with sorafenib.

"While this study didn't confirm the very promising results of phase II studies with sorafenib, it is important to share its findings since the double chemotherapy combination of carboplatin and paclitaxel has achieved results that eclipse previous chemotherapy results in large phase III trials. These results take us one step closer to understanding how to most effectively treat metastatic melanoma," said Dr. Kirkwood.

Melanoma is a rare form of skin cancer, but it causes the majority of skin-cancer related deaths. Each year, approximately 160,000 new cases are diagnosed worldwide. Surgery effectively cures early disease, but once it has spread to regional lymph nodes or distant sites, a cure is more elusive. Only two therapies in current usage have been approved by the U.S. Food and Drug Administration for treatment of advanced melanoma, and neither has been shown to prolong survival.