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Long-term Survival with Ipilimumab: Experience from a National Expanded Access Program for Patients with Melanoma

I. Krajsová, P. Arenberger, R. Lakomý, E. Kubala, I. Březinová, A. Poprach, M. Šťastný, J. Mužík, B. Melichar,

. 2015 ; 35 (11) : 6303-10.

Language English Country Greece

Document type Journal Article, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc16009921

AIM: Evaluation of efficacy and safety of ipilimumab in patients with advanced, refractory melanoma enrolled into a national ipilimumab Expanded Access Program. PATIENTS AND METHODS: Adult patients with advanced/metastatic refractory melanoma were eligible for study inclusion. Ipilimumab was administered up to a total of four doses. RESULTS: One hundred and ninety-six patients were analyzed. Full ipilimumab induction was administered to 66.8% of patients. Median overall survival (OS) in the entire cohort was 7.5 months. Median OS for patients after four doses of ipilimumab was significantly longer than for patients with fewer doses (12.3 months vs. 2.0 months respectively; p<0.001). Median OS for patients with objective tumor response was 42.3 months. Normal baseline serum lactate dehydrogenase (LDH) and C-reactive protein (CRP) levels, and the number of affected organs correlated with improved OS. CONCLUSION: The number of affected organs and combination of baseline LDH and CRP levels could potentially serve as predictors for both treatment response and OS.

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$a AIM: Evaluation of efficacy and safety of ipilimumab in patients with advanced, refractory melanoma enrolled into a national ipilimumab Expanded Access Program. PATIENTS AND METHODS: Adult patients with advanced/metastatic refractory melanoma were eligible for study inclusion. Ipilimumab was administered up to a total of four doses. RESULTS: One hundred and ninety-six patients were analyzed. Full ipilimumab induction was administered to 66.8% of patients. Median overall survival (OS) in the entire cohort was 7.5 months. Median OS for patients after four doses of ipilimumab was significantly longer than for patients with fewer doses (12.3 months vs. 2.0 months respectively; p<0.001). Median OS for patients with objective tumor response was 42.3 months. Normal baseline serum lactate dehydrogenase (LDH) and C-reactive protein (CRP) levels, and the number of affected organs correlated with improved OS. CONCLUSION: The number of affected organs and combination of baseline LDH and CRP levels could potentially serve as predictors for both treatment response and OS.
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$a Arenberger, Petr $u Department of Dermatology, University Hospital Vinohrady Prague, and Charles University Third Medical Faculty, Prague, Czech Republic. $7 nlk19990072992
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$a Lakomý, Radek $u Department of Comprehensive Cancer Care, Masaryk Oncology Institute Brno, Brno, Czech Republic.
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$a Kubala, Eugen $u Department of Oncology and Radiotherapy, University Hospital Hradec Králové, Hradec Králové, Czech Republic.
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$a Březinová, Ivana $u Department of Oncology, Teaching Hospital Ostrava, Ostrava, Czech Republic.
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$a Poprach, Alexandr $u Department of Comprehensive Cancer Care, Masaryk Oncology Institute Brno, Brno, Czech Republic.
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$a Mužík, Jan $u Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
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$a Melichar, Bohuslav $u Department of Oncology, Palacky University Medical School and University Hospital Olomouc, Olomouc, Czech Republic.
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