Meldola, Italy
Meldola, Italy

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Altomonte M.,University of Siena | Di Giacomo A.M.,University of Siena | Queirolo P.,Italian National Cancer Institute | Ascierto P.A.,Instituto Nazionale Tumori Fondazione G Pascale | And 12 more authors.
Journal of Experimental and Clinical Cancer Research | Year: 2013

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. © 2013 Altomonte et al.; licensee BioMed Central Ltd.

Maio M.,Instituto Toscano Tumori | Ascierto P.,Instituto Nazionale Tumori | Testori A.,Instituto Europeo Of Oncologia | Ridolfi R.,IRCCS IRST | And 12 more authors.
Journal of Experimental and Clinical Cancer Research | Year: 2012

Background: In recent decades, melanoma incidence has been increasing in European countries; in 2006, there were approximately 60,000 cases leading to 13,000 deaths. Within Europe there is some geographical variation in the incidence of melanoma, with the highest rates reported in Scandinavia (15 cases per 100,000 inhabitants per year) and the lowest in the Mediterranean countries (5 to 7 cases per 100,000 inhabitants per year). Methods. The present article is based on the information collected in the MELODY study (MELanoma treatment patterns and Outcomes among patients with unresectable stage III or stage IV Disease: a retrospective longitudinal survey).In that study, the medical charts of patients were reviewed to document current treatment patterns and to analyse information on patients, disease characteristics and healthcare resource utilization related to the treatment of advanced melanoma regarding patients who presented with a diagnosis of malignant melanoma (stage I to IV) at participating sites between 01 July, 2005 and 30 June, 2006. Results: Summarizing, though the length of the follow-up period varies among sample patients, an amount of the yearly cost per patient can be estimated, dividing the average per patient total cost (€5.040) by the average follow-up duration (17.5 months) and reporting to one year; on these grounds, unresectable stage III or stage IV melanoma in Italy would cost 3,456 per patient per year. © 2012 Maio et al.; licensee BioMed Central Ltd.

Santelmo C.,Rimini Street | Ravaioli A.,IRCCS IRST | Barzotti E.,Rimini Street | Papi M.,Rimini Street | And 5 more authors.
Lung Cancer | Year: 2013

The coexistence of EGFR and ALK-EML4 gene mutations represents a rare event (about 1%) in patients with non small cell lung cancer (NSCLC) and the few cases described in the literature have all been treated by different methods. We present the case of a 52-year-old woman with adenocarcinoma of the lung whose tumor had this double genetic aberration. The patient was immediately treated with gefitinib because the tumor was judged inoperable, but after two months she obtained an important clinical remission and was submitted to radical surgery. She is currently undergoing adjuvant treatment with gefitinib. A review of the literature on this double genetic aberration highlighted that further research is needed to define the best therapeutic approach. © 2013 Elsevier Ireland Ltd.

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