Long-term Survival with Ipilimumab: Experience from a National Expanded Access Program for Patients with Melanoma.
OBJECTIVE
Evaluation of efficacy and safety of ipilimumab in patients with advanced, refractory melanoma enrolled into a national ipilimumab Expanded Access Program.


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.


CONCLUSIONS
The number of affected organs and combination of baseline LDH and CRP levels could potentially serve as predictors for both treatment response and OS.
Department of Dermato-oncology, University Hospital Prague, and Charles University First Medical Faculty, Prague, Czech Republic Ivana.Krajsova@vfn.cz.
Ivana
I
Krajsová
Department of Dermatology, University Hospital Vinohrady Prague, and Charles University Third Medical Faculty, Prague, Czech Republic.
Petr
P
Arenberger
Department of Comprehensive Cancer Care, Masaryk Oncology Institute Brno, Brno, Czech Republic.
Radek
R
Lakomý
Department of Oncology and Radiotherapy, University Hospital Hradec Králové, Hradec Králové, Czech Republic.
Eugen
E
Kubala
Department of Oncology, Teaching Hospital Ostrava, Ostrava, Czech Republic.
Ivana
I
Březinová
Department of Comprehensive Cancer Care, Masaryk Oncology Institute Brno, Brno, Czech Republic.
Alexandr
A
Poprach
Bristol-Myers Squibb CZ, Prague, Czech Republic.
Marek
M
Šťastný
Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Jan
J
Mužík
Department of Oncology, Palacky University Medical School and University Hospital Olomouc, Olomouc, Czech Republic.
Bohuslav
B
Melichar
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000074324:Ipilimumab; D007770:L-Lactate Dehydrogenase / Q000378:metabolism; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D012449:Safety; D016879:Salvage Therapy; D015996:Survival Rate; D013997:Time Factors; D055815:Young Adult
D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000074324:Ipilimumab; D002097:C-Reactive Protein; D007770:L-Lactate Dehydrogenase
Melanoma; ipilimumab; safety; survival