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

J Chemother. 2017 Aug;29(4):245-251. doi: 10.1080/1120009X.2017.1311444. Epub 2017 Apr 11.

Abstract

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.

Keywords: Ipilimumab; Melanoma; Monoclonal antibodies; Oncology; Registries; Retrospective studies.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents, Immunological / therapeutic use*
  • Female
  • Humans
  • Ipilimumab / therapeutic use*
  • Male
  • Melanoma / drug therapy*
  • Middle Aged
  • Prognosis
  • Retrospective Studies
  • Safety
  • Skin Neoplasms / drug therapy*
  • Survival Rate

Substances

  • Antineoplastic Agents, Immunological
  • Ipilimumab