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Multicenter Study
. 2013 Oct 25;32(1):82.
doi: 10.1186/1756-9966-32-82.

Clinical experience with ipilimumab 10 mg/kg in patients with melanoma treated at Italian centres as part of a European expanded access programme

Maresa Altomonte, Anna Di Giacomo, Paola Queirolo, Paolo Ascierto, Francesco Spagnolo, Emilio Bajetta, Luana Calabrò, Riccardo Danielli, Francesco de Rosa, Michela Maur, Vanna Chiarion-Sileni, Pier Ferrucci, Diana Giannarelli, Alessandro Testori, Ruggero Ridolfi, Michele Maio
Multicenter Study

Clinical experience with ipilimumab 10 mg/kg in patients with melanoma treated at Italian centres as part of a European expanded access programme

Maresa Altomonte et al. J Exp Clin Cancer Res. .

Abstract

Background: Patients with advanced melanoma are faced with a poor prognosis and, until recently, limited treatment options. Ipilimumab, a novel immunotherapy that blocks cytotoxic T-lymphocyte-associated antigen-4, was the first agent to improve survival of patients with advanced melanoma in a randomised, controlled phase 3 trial. We used data from an expanded access programme (EAP) at Italian centres to evaluate the clinical activity and safety profile of ipilimumab 10 mg/kg in patients with advanced melanoma in a setting more similar to that of daily practice.

Methods: Data were collected from patients enrolled in an ipilimumab EAP across eight participating Italian centres. As per the EAP protocol, patients had life-threatening, unresectable stage III/IV melanoma, had failed or did not tolerate previous treatments and had no other therapeutic option available. Treatment comprised ipilimumab 10 mg/kg every 3 weeks for a total of four doses. If physicians believed patients would continue to derive benefit from ipilimumab treatment, maintenance therapy with ipilimumab 10 mg/kg was provided every 12 weeks. Tumour responses were assessed every 12 weeks using modified World Health Organization criteria and safety continuously monitored.

Results: Seventy-four pretreated patients with advanced melanoma were treated with ipilimumab 10 mg/kg. Of these, 9 (13.0%) had an objective response, comprising 3 patients with a complete response and 6 with a partial response. Median overall survival was 7.0 months (95% confidence interval, 5.3-8.7) and 16.6% of patients were alive after 3 years. Forty-five patients (60.8%) reported treatment-related adverse events of any grade, which were most commonly low-grade pruritus, pain, fever and diarrhoea. Grade 3 or 4 treatment-related AEs were reported in 8 patients (10.8%).

Conclusions: The clinical activity and safety profile of ipilimumab 10 mg/kg in the EAP was similar to that seen in previous clinical trials of ipilimumab in pretreated patient populations.

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Figures

Figure 1
Figure 1
Kaplan–Meier analysis of OS among 74 patients receiving ipilimumab 10 mg/kg at Italian centres participating in an EAP.EAP expanded access programme, OS overall survival.
Figure 2
Figure 2
Kaplan–Meier analysis of progression-free survival among 74 patients receiving ipilimumab 10 mg/kg at Italian centres participating in an EAP.EAP expanded access programme, PFS progression-free survival.
See this image and copyright information in PMC

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