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Journal of Experimental & Clinical Cancer Research

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Open Access 01-12-2014 | Research

Efficacy and safety of ipilimumab in elderly patients with pretreated advanced melanoma treated at Italian centres through the expanded access programme

Authors: Vanna Chiarion Sileni, Jacopo Pigozzo, Paolo Antonio Ascierto, Antonio Maria Grimaldi, Michele Maio, Lorenza Di Guardo, Paolo Marchetti, Francesco de Rosa, Carmen Nuzzo, Alessandro Testori, Emilia Cocorocchio, Maria Grazia Bernengo, Michele Guida, Riccardo Marconcini, Barbara Merelli, Giorgio Parmiani, Gaetana Rinaldi, Massimo Aglietta, Marco Grosso, Paola Queirolo

Published in: Journal of Experimental & Clinical Cancer Research | Issue 1/2014

Abstract

Background

Elderly patients with metastatic melanoma have different disease characteristics and a poorer prognosis than younger patients. Data from clinical trials and expanded access programmes (EAPs) suggest ipilimumab confers a consistent survival benefit and has a similar safety profile across different age groups of patients with metastatic melanoma. Here we report the efficacy and safety of ipilimumab 3 mg/kg in elderly patients enrolled in an EAP in Italy.

Methods

Patients aged > 70 years with pretreated melanoma received ipilimumab 3 mg/kg every 3 weeks for four doses through an EAP. Tumour response was evaluated at baseline and after completion of induction therapy using immune-related response criteria and patients were monitored throughout the treatment period for adverse events (AEs), including immune-related AEs.

Results

The immune-related disease control rate among 188 evaluable patients was 38%, including four patients with an immune-related complete response, 24 with an immune-related partial response and 44 with immune-related stable disease. Median progression-free survival (PFS) was 4.0 months and the 1- and 2-year PFS rates were 21% and 12%, respectively. Median overall survival (OS) was 8.9 months; 1- and 2-year OS rates were 38% and 22%, respectively. The safety profile of ipilimumab was consistent with that observed in the general population of the Italian EAP and treatment-related AEs generally resolved within a median of 2 weeks with treatment as per protocol-specific guidelines.

Conclusions

These results suggest ipilimumab is a feasible treatment option in elderly patients with metastatic melanoma. Ipilimumab treatment was generally well tolerated and resulted in clinical benefit and extended survival in elderly patients treated at centres in Italy.

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Title: Efficacy and safety of ipilimumab in elderly patients with pretreated advanced melanoma treated at Italian centres through the expanded access programme
Authors: Vanna Chiarion Sileni
Jacopo Pigozzo
Paolo Antonio Ascierto
Antonio Maria Grimaldi
Michele Maio
Lorenza Di Guardo
Paolo Marchetti
Francesco de Rosa
Carmen Nuzzo
Alessandro Testori
Emilia Cocorocchio
Maria Grazia Bernengo
Michele Guida
Riccardo Marconcini
Barbara Merelli
Giorgio Parmiani
Gaetana Rinaldi
Massimo Aglietta
Marco Grosso
Paola Queirolo
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: Journal of Experimental & Clinical Cancer Research / Issue 1/2014
Electronic ISSN: 1756-9966
DOI: https://doi.org/10.1186/1756-9966-33-30

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