New-Generation Immunotherapy Made a Difference in Malignant Melanoma at High Risk of Recurrence

Malignant melanoma is a type of skin cancer with a high likelihood of recurrence after surgery even when detected at an early stage. We use the immune therapy called interferon as preventive treatment, particularly in high-risk patients, to prevent the disease from recurring after surgery. However, few patients can complete the treatment period of 1 year because of the side effects of this drug. Even if this arduous process is completed, the drug’s effectiveness, that is, its protective effect, is generally weak. “Is the result worth the effort and trouble?” is a question we often ask ourselves, and as physicians we watch for new studies in this area.

As is known, in recent years, in stage 4 malignant melanoma that has spread to other organs through metastasis , new-generation immunotherapy drugs have achieved considerable success and have rapidly entered use worldwide. However, immunotherapies had until now been approved only for use in advanced malignant melanoma.

Can new-generation immune drugs that work in advanced disease also work as preventive treatment in early-stage patients, particularly those at high risk of recurrence?

One study setting out with this aim was conducted in patients who had undergone surgery for stage-3 malignant melanoma skin cancer. In these patients, preventive (adjuvant) treatment with the new-generation immune therapy ipilumab was found to reduce the recurrence rate compared with patients receiving no treatment. In the study, which included 951 patients, overall survival at 5 years showed an 11% benefit that could be considered significant.

In terms of side effects, a marked increase was found in the treatment arm compared with the placebo (dummy treatment) arm, but these effects were found manageable. Severe (grade 3-4) side effects developed in 54% of patients, while 1% of patients lost their lives because of side effects.

In light of these results, in 2016, ESMO (European Oncology Congress) seems likely to see continuing repercussions from this study, which sparked discussion among oncology specialists about its translation into clinical practice. In the group of patients with malignant melanoma at risk of recurrence, the first positive results for a new-generation immunotherapy drug instead of interferon, whose benefit after surgery is debated, offered a ray of hope for our patients.

The results we obtain after detailed analyses of the study and identification of the patient group benefiting most from treatment appear likely to change our preventive treatment strategy in the near future.