Long-term Survival with Ipilimumab: Experience from a National Expanded Access Program for Patients with Melanoma

Anticancer Res. 2015 Nov;35(11):6303-10.

Abstract

Aim: Evaluation of efficacy and safety of ipilimumab in patients with advanced, refractory melanoma enrolled into a national ipilimumab Expanded Access Program.

Patients and methods: Adult patients with advanced/metastatic refractory melanoma were eligible for study inclusion. Ipilimumab was administered up to a total of four doses.

Results: One hundred and ninety-six patients were analyzed. Full ipilimumab induction was administered to 66.8% of patients. Median overall survival (OS) in the entire cohort was 7.5 months. Median OS for patients after four doses of ipilimumab was significantly longer than for patients with fewer doses (12.3 months vs. 2.0 months respectively; p<0.001). Median OS for patients with objective tumor response was 42.3 months. Normal baseline serum lactate dehydrogenase (LDH) and C-reactive protein (CRP) levels, and the number of affected organs correlated with improved OS.

Conclusion: The number of affected organs and combination of baseline LDH and CRP levels could potentially serve as predictors for both treatment response and OS.

Keywords: Melanoma; ipilimumab; safety; survival.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / therapeutic use*
  • Antineoplastic Agents / therapeutic use*
  • C-Reactive Protein / metabolism
  • Drug Resistance, Neoplasm / drug effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Ipilimumab
  • L-Lactate Dehydrogenase / metabolism
  • Male
  • Melanoma / drug therapy
  • Melanoma / mortality*
  • Melanoma / pathology
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local / drug therapy
  • Neoplasm Recurrence, Local / mortality*
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Staging
  • Prognosis
  • Safety
  • Salvage Therapy*
  • Survival Rate
  • Time Factors
  • Young Adult

Substances

  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • Ipilimumab
  • C-Reactive Protein
  • L-Lactate Dehydrogenase