Is nivolumab safe and effective for the treatment of advanced melanoma in the real-world clinical practice?

This study evaluated the safety and effectiveness of nivolumab (Opdivo) in patients with advanced melanoma in a real-world practice. The study found that the safety and effectiveness of nivolumab in these patients were similar to that reported in clinical trials.

Melanoma is a form of skin cancer. In more advanced melanoma, the tumor can spread to other parts of the body (metastasis). Patients with metastatic melanoma (MM) have limited treatment options. Metastasis to the brain is particularly hard to treat.  

The immune system tries to fight off diseases like cancer. There are checkpoints in the immune system to make sure it does not get out of control. Cancer cells can turn off the immune system by switching on these checkpoints. Therapies have been developed that prevent cancer cells from switching on these checkpoints. These therapies are called checkpoint inhibitors. Nivolumab is a newly developed checkpoint inhibitor. It has shown to be effective in clinical trials.

However, patients are carefully selected for clinical trials. They are usually young and fit, without significant medical conditions apart from the MM. Therefore, it is not currently clear if nivolumab is safe and effective for the treatment of MM in a real-world practice.

This study included data from 400 patients with MM. All patients had been given nivolumab. 83% of patients had at least one type of therapy before nivolumab (group 1). 17% received nivolumab as a first treatment (group 2). Patients were treated for an average of 9.9 months. 

Overall, 31.6% of patients responded to treatment. 32.7% of group 1 responded to nivolumab. 41.8% of group 2 had a response to nivolumab. The survival time without progression of the disease was 3.2 months in group 1 and 4.7 months in group 2.

13.8% of patients reported severe to life-threatening side effects such as bowel and liver-related or lung-related. 

The study concluded that nivolumab was safe and effective in treating patients with advanced MM in a real-world practice.

This study evaluated data from medical records. Nivolumab treatment was not randomized. 90.8% of patients stopped nivolumab treatment due to progression of the disease, or side effects. This study was funded by Bristol-Myers Squibb, the manufacturer of nivolumab.