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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-12

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

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. More... »

PAGES

30

References to SciGraph publications

  • 2009-06. Age-Related Lymphatic Dysfunction in Melanoma Patients in ANNALS OF SURGICAL ONCOLOGY
  • 2004-03. Correlation Between Prognostic Factors and Increasing Age in Melanoma in ANNALS OF SURGICAL ONCOLOGY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/1756-9966-33-30

    DOI

    http://dx.doi.org/10.1186/1756-9966-33-30

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1023400666

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/24708900


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