In a nutshell
The authors analyzed the 5-year survival rate in advanced melanoma patients treated with a combination of ipilimumab (Yervoy) and dacarbazine (DTIC, DTIC-Dome) in a phase III clinical trial.
Some background
In advanced melanoma (stage III/IV), cancer spreads from the skin to other parts of the body. Overall survival (patients who are still alive after treatment) in advanced melanoma is poor. Less than 10% of stage IV patients survive more than 5 years. One of the standard treatments for advanced melanoma is immunotherapy. Immunotherapy uses the body’s own immune system to fight cancer. Ipilimumab is an immunotherapy, which has shown considerable survival benefits in advanced melanoma. In several phase II clinical trials of ipilimumab, the 5-year survival rates in previously untreated patients were 21.4% to 49.5%.
Randomized (patients are randomly assigned to receive the treatment) clinical trials in a larger patient population are needed to further understand the benefit of ipilimumab.
Methods & findings
The authors aimed to analyze the benefit of combination treatment with ipilimumab and dacarbazine (a chemotherapy) in the survival of advanced melanoma patients.
502 melanoma patients (stage III/IV) were included in this phase III trial. None of the patients had received any previous treatments. In group 1, 250 patients were randomly assigned to receive ipilimumab plus dacarbazine. In group 2, 252 patients were randomly assigned to receive a placebo (inactive drug used in the place of the active drug) plus dacarbazine.
The overall survival was 11.2 months in group 1 and 9.1 months in group 2. 18.2% of patients in group 1 were alive 5 years following treatment. This was compared to 8.8% of patients in group 2. In group 1, 7.5% of patients experienced a complete disappearance of the tumor and 42.5% of patients experienced a 50% reduction in tumor volume.
Severe or life threatening skin-related side effects (rashes and severe itching of the skin) were associated with patients who survived for more than 5 years and were still receiving ipilimumab treatment.
The bottom line
The authors concluded that ipilimumab had significant long-term survival benefits in advanced melanoma.
Published By :
Journal of clinical oncology
Date :
Feb 23, 2015
