The efficacy and safety of ipilimumab in patients with advanced cutaneous or mucosal melanoma

Introduction. Ipilimumab is a monoclonal antibody registered for the treatment of patients with unresectable or metastatic melanoma. Studies have shown prolongation of overall survival in patients treated with ipilimumab. Adverse events related to excessive stimulation of the immune system may occur during treatment. The aim of this paper was to analyse the results of treatment with the use of ipilimumab, which were achieved in one institution in the frame of a therapeutic program established in Poland. Materials and methods. Forty-seven patients (27 men, 20 women) were treated from April 2014 to February 2015 with ipilimumab in a dose of 3 mg/kg of body weight after failure of one previous systemic line of treatment. Median age at the beginning of the treatment was 54 years (range 18–73). Nineteen patients (40%) had BRAF mutation. Thirty patients received chemotherapy as first-line treatment prior to ipilimumab, 14 patients were given vemurafenib, and three patients were treated in clinical trials. Performance status 0 or 1 was found in 15 patients and 32 patients, respectively. Five patients (10.6%) had asymptomatic brain metastases. Twenty-four (51%) patients had metastatic disease with three or less organs involved, whereas 23 (49%) patients had metastases in more than three organs. Lactate dehydrogenase (LDH) activity and neutrophil count was elevated at the beginning of treatment in 40% and 30% of patients, respectively. Results. Thirty-five patients (74%) completed four doses of treatment. Four patients (8.5%) had partial response to the treatment, 12 patients (25.5%) had stable disease (SD) for three or more months, and 31 (66%) had progressive disease. Sixteen patients (34%) had clinical benefit from the treatment (PR + SD). Median progression-free survival (PFS) time was two months. Median overall survival (OS) time was 7.5 months. Increased LDH activity at the beginning of treatment and elevated neutrophil count significantly influenced overall survival of patients (p = 0.005 and p = 0.01, respectively). After progression on ipilimumab 25 patients (53%) received further lines of systemic treatment. Conclusions. This analysis confirms the efficacy of ipilimumab in some patients with advanced melanoma in second-line systemic therapy. A limited proportion of patients obtain long lasting control of the disease after use of ipilimumab with good tolerance to the treatment. There is a need to determine predictive factors of response to treatment for better selection of patients.Introduction. Ipilimumab is a monoclonal antibody registered for the treatment of patients with unresectable or metastatic melanoma. Studies have shown prolongation of overall survival in patients treated with ipilimumab. Adverse events related to excessive stimulation of the immune system may occur during treatment. The aim of this paper was to analyse the results of treatment with the use of ipilimumab, which were achieved in one institution in the frame of a therapeutic program established in Poland. Materials and methods. Forty-seven patients (27 men, 20 women) were treated from April 2014 to February 2015 with ipilimumab in a dose of 3 mg/kg of body weight after failure of one previous systemic line of treatment. Median age at the beginning of the treatment was 54 years (range 18–73). Nineteen patients (40%) had BRAF mutation. Thirty patients received chemotherapy as first-line treatment prior to ipilimumab, 14 patients were given vemurafenib, and three patients were treated in clinical trials. Performance status 0 or 1 was found in 15 patients and 32 patients, respectively. Five patients (10.6%) had asymptomatic brain metastases. Twenty-four (51%) patients had metastatic disease with three or less organs involved, whereas 23 (49%) patients had metastases in more than three organs. Lactate dehydrogenase (LDH) activity and neutrophil count was elevated at the beginning of treatment in 40% and 30% of patients, respectively. Results. Thirty-five patients (74%) completed four doses of treatment. Four patients (8.5%) had partial response to the treatment, 12 patients (25.5%) had stable disease (SD) for three or more months, and 31 (66%) had progressive disease. Sixteen patients (34%) had clinical benefit from the treatment (PR + SD). Median progression-free survival (PFS) time was two months. Median overall survival (OS) time was 7.5 months. Increased LDH activity at the beginning of treatment and elevated neutrophil count significantly influenced overall survival of patients (p = 0.005 and p = 0.01, respectively). After progression on ipilimumab 25 patients (53%) received further lines of systemic treatment. Conclusions. This analysis confirms the efficacy of ipilimumab in some patients with advanced melanoma in second-line systemic therapy. A limited proportion of patients obtain long lasting control of the disease after use of ipilimumab with good tolerance to the treatment. There is a need to determine predictive factors of response to treatment for better selection of patients