Ipilimumab in real-world clinical practice: efficacy and safety data from a multicenter observational study.

In patients with metastatic melanoma, ipilimumab has been shown to improve long-term survival. This observational multicenter study reports clinical outcomes of 418 patients treated with second-line ipilimumab from February 2013 to August 2014. Median overall survival (OS) was 6.43 months (95%CI: 5.45-7.42; n = 300), while median progression-free survival (PFS) was 3.7 months (95%CI: 3.23-4.17; n = 188). Demographic factors, such as sex or number of previous therapies did not affect OS. Survival was shorter in patients with ECOG > 0 (Eastern Cooperative Oncology Group, Performance Status) (p < 0.001), while a longer OS was found in patients who completed all four therapy cycles (p < 0.001). Adverse events of any grade were reported for 66% of patients (mainly cutaneous and gastrointestinal), but most were low grade and easily managed. Adverse events of grades 3-4 were observed in 13% of patients. This study confirmed the efficacy and safety of this treatment in real practice.