DFS could not be determined because of lack of data
DFS could not be determined because of lack of data. response in 1 . 3%, PR in 9. 6%, PR with previous SB399885 HCl progression 8. 4%, stabilized disease in 14. 5%, and progressive disease in 66. 2%. The median OS was 6. 5 months (199 days); 1-year survival was 32. 9%. Predictive survival factors included lymphocytes over 1000/ml (P=0. 0008) and lactate dehydrogenase more than 1 . 5upper limit of normal (P=0. 003). Cutaneous, hepatic, and gastrointestinal toxicities were mild. In 30 patients older more than 70 years, ipilimumab efficacy and tolerability was similar to that of the overall population. In the clinical practice setting, ipilimumab is effective and well tolerated in patients with advanced melanoma, including elderly patients, when administered at the recommended dosage. Ipilimumab improves treatment options intended for patients who, until recently, have had little hope of an improved prognosis. Keywords: Expanded Access Program, ipilimumab, melanoma, questionnaire, retrospective study == Introduction == The incidence of melanoma continues to increase more rapidly than any other malignancy, except for lung cancer in women1. In 2008, estimates of annual age-standardized incidence were 2 . 8/100 000 population worldwide and 6. 8/100 000 in Europe2. In SB399885 HCl Spain, the estimated annual ECT2 age-standardized melanoma incidence was 5. 6/100 0002. The prognosis intended for patients with advanced melanoma is poor as it is often highly resistant to chemotherapy, radiotherapy, hormonal therapy, and older immunotherapeutic approaches. As a result, the median overall survival (OS) of patients with metastatic disease is less than 9 months3, with a 10-year observed survival rate of 1015%4. Numerous treatment options, mostly local/regional, are available for patients presenting with metastatic disease. These include cytotoxic drugs such as dacarbazine, taxanes SB399885 HCl such as paclitaxel, nitrosoureas such as fotemustine, targeted therapy with vemurafenib for patients with the V600BRAFgene mutation, and immunotherapy with interferon, high-dose interleukin-2, and ipilimumab1, 5. However , apart from ipilimumab and vemurafenib, most of these options have only yielded modest treatment response rates and negligible to modest improvements in survival in first-line and second-line treatment settings3, 69. Therefore , improving OS remains a key objective in this patient population10. Ipilimumab is a promising new immunotherapy11. It is a fully human, recombinant monoclonal antibody targeted at cytotoxic T-lymphocyte antigen 4 (CTLA-4)11. Ipilimumab blocks the inhibitory action of CTLA-4, causing T-cell activation and proliferation, thereby enhancing the immune response specifically the cytotoxic T-cell-mediated antitumor response11. In a phase III randomized trial, ipilimumab improved OS in patients with previously treated metastatic melanoma compared with a glycoprotein 100 peptide vaccine (gp100)12. The median OS with ipilimumab plus gp100 was 10. 0 months [hazard ratio (HR) for death vs . gp100 alone, 0. 68; P <0. 001] and 10. 1 months with ipilimumab only (HR intended for death vs . gp100 only, 0. 66; P=0. 003), with no difference SB399885 HCl between the ipilimumab groups (HR, 1 . 04; P=0. 76)12. Ipilimumab is also effective in patients with untreated metastatic melanoma when administered in combination with dacarbazine9. Due to these data, ipilimumab is approved for use in Europe in adult patients with advanced (unresectable or metastatic) melanoma who have been treated previously13. Ipilimumab is acknowledged in the European Society for Medical Oncology guidelines as being a promising treatment intended for melanoma, but was not recommended as publication of these guidelines5preceded that of the phase III ipilimumab trial12. Ipilimumab is approved in the USA in those with unresectable or metastatic disease14, and is among the preferred regimens recommended by the National Comprehensive Cancer Network for patients with advanced or metastatic melanoma1. There is no evidence for the use of ipilimumab in Spain in a real-world setting. The manufacturer of ipilimumab made the drug available in Spain under an Expanded Access Program (EAP) following European marketing authorization but before drug launch. To date, results data intended for patients enrolled in this program have not been published in full, although these and other retrospective studies.