Ipilimumab brings benefit in advanced melanoma patients, according to study

Ipilimumab brings benefit in advanced melanoma patients, according to study

German Institute for Quality and Efficiency in Health Care (IQWiG) compared the benefit of ipilimumab, a drug used in treating patients with metastatic melanoma,  compared with so-called “best supportive care”.

The study included patients who were divided into 3 groups: the first group was treated with ipilimumab, the second group was treated with ipilimumab and an experimental tumor vaccine (gp100) which has not yet been approved, and the third group received placebo and the tumor vaccine. The researchers conducted a randomized trial to see if ipilimumab has an added benefit than other therapies.

Ipilimumab

Ipilimumab is a humanized monoclonal antibody that was approved in 2011 to treat advanced melanoma. Melanoma is a skin cancer with very poor prognosis. Although it represents only 5% of all skin cancers, melanoma is responsible for 80% of skin cancer deaths. Basic treatment consists of surgical excision with oncological safety limits, but if the disease is advanced, that is if there are many metastases, surgical excision does not bring any benefit to the patient. If the number of metastases is limited  ( 1-5), they can be excised.

The risk of melanoma increases if the patient has relatives who have had melanoma or if the patient has melanocytic nevi. In addition, it appears that exposure to ultraviolet radiation plays a role in melanoma occurrence. It should be noted that melanoma can occur both in healthy skin and in underlying lesions. There is a mnemonic formula for signs of malignant degeneration of a melanocytic nevus. ABCDE means asymmetry, irregular borders, color change, diameter grater than 6 mm and enlargement. Any melanocytic nevus  that begins to grow in size, changes color or bleeds should be evaluated by a physician.

IQWiG researchers wanted to assess whether ipilimumab brings any benefit to patients with advanced disease. They focused on evaluating several aspects such as survival time, symptoms complaints and quality of life. The conclusion was that ipilimumab brings benefit because it prolongs survival. Patients who did not receive ipilimumab died after 6.5 months while patients who received the drug lived 10 months. It was also found that there was no difference in terms of quality of life between ipilimumab and placebo. Patients had the same health status and symptoms: nausea, vomiting, digestive disorders, fatigue, pain.

Regarding discontinuation of treatment, it was observed that more patients who received ipilimumab discontinued the therapy due to adverse reactions. However, it has not been proven that ipilimumab is more harmful even though there is an indication of greater harm.