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

Journal of Experimental & Clinical Cancer Research

Michele Maio⁶  Ruggero Ridolfi⁵  Alessandro Testori¹  Diana Giannarelli³  Pier Francesco Ferrucci¹  Vanna Chiarion-Sileni⁹  Michela Maur⁴  Francesco de Rosa⁵  Riccardo Danielli⁶  Luana Calabrò⁶  Emilio Bajetta²  Francesco Spagnolo⁸  Paolo Antonio Ascierto⁷  Paola Queirolo⁸  Anna Maria Di Giacomo⁶  Maresa Altomonte⁶ 

[1] Istituto Europeo di Oncologia, Milan, Italy;Istituto di Oncologia, Policlinico di Monza, Monza, Italy;Statistics, Regina Elena National Cancer Institute, Rome, Italy;University Hospital, Modena, Italy;IRCCS - IRST, Meldola, Forlì-Cesena, Italy;University Hospital of Siena, Siena, Italy;Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy, Istituto Nazionale Tumori Fondazione “G. Pascale”, Naples, Italy;San Martino Hospital, National Institute for Cancer Research, Genoa, Italy;Oncology Institute of Veneto, Padua, Italy

关键词: Metastatic melanoma;    Ipilimumab;    Expanded access programme;    Compassionate use;   

Others  :  814977
DOI  :  10.1186/1756-9966-32-82

 received in 2013-08-22, accepted in 2013-10-16,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Altomonte et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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