title: Single-center experience with ipilimumab in an expanded access program for patients with pretreated advanced melanoma.
abstract: Ipilimumab, a CTLA-4-blocking monoclonal antibody, improved the overall survival (OS) of advanced melanoma patients treated in prospective clinical trials. We here report a study on the outcome of patients with pretreated advanced melanoma offered ipilimumab (at its licensed dose of 3 mg/kg, every 3 wk for a total of 4 doses) in an expanded access program at a single-center university hospital. Of the 50 patients initiating ipilimumab, 31 patients completed induction therapy and 9 patients were offered reinduction therapy. Most immune-related adverse events were mild and reversible. The best objective response rate by mWHO-criteria included 1 complete response and 4 partial responses (best objective response rate of 10%). Two additional patients obtained a partial response by immune-related response criteria. Median OS was 7 months, with a 1- and 2-year survival rate of 45.2% and 28.8%, respectively. Long-term disease control with ipilimumab was observed in 7 patients of which 4 received reinduction. Baseline serum C-reactive protein (CRP) and the absolute lymphocyte count (ALC) measured on week 6 significantly correlated with OS. In conclusion, in this single-center experience with ipilimumab for advanced pretreated melanoma patients, clinical outcome was comparable with the results of published prospective studies. Reinduction therapy was of importance for maintaining long-term disease control in the majority of responding patients. Baseline CRP and ALC at week 6 deserve further prospective evaluation as prognostic and/or predictive (surrogate) markers.
authors.affiliation: Department of Medical Oncology, UZ Brussel, Brussels, Belgium.
authors.forename: Sofie
authors.initials: S
authors.lastname: Wilgenhof
authors.forename: Stephanie
authors.initials: S
authors.lastname: Du Four
authors.forename: Frederik
authors.initials: F
authors.lastname: Vandenbroucke
authors.forename: Hendrik
authors.initials: H
authors.lastname: Everaert
authors.forename: Isabelle
authors.initials: I
authors.lastname: Salmon
authors.forename: Danielle
authors.initials: D
authors.lastname: Liénard
authors.forename: Véronique Del
authors.initials: VD
authors.lastname: Marmol
authors.forename: Bart
authors.initials: B
authors.lastname: Neyns
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000032:analysis; D060908:CTLA-4 Antigen / Q000276:immunology; D005260:Female; D006801:Humans; D000074324:Ipilimumab; D018655:Lymphocyte Count; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000276:immunology; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D060908:CTLA-4 Antigen; D000074324:Ipilimumab; D002097:C-Reactive Protein