| Autor: |
Irina Baldueva, Svetlana Protsenko, Gulfiya Midhatovna Teletaeva, Yekaterina Yaremenko, Aleksey Novik, Dilorom Latipova, Tatyana Semiglazova, V. Rubinchik, Anna Semenova, Yekaterina Anokhina, Ani Oganesyan |
| Rok vydání: |
2018 |
| Předmět: |
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| Zdroj: |
Problems in oncology. 64:388-393 |
| ISSN: |
0507-3758 |
| Popis: |
Ipilimumab (IPI) provides a ten-year overall survival in almost 20 % of selected patients participated in several phase II-III trials. However, the expanded access program (EAP) looks more like routine practice than like clinical trials& This is why the results of such application could be different. Here we present the long-term follow-up data of single center EAP. Ninety-six patients with disseminated melanoma progressing after at least one lines of drug therapy were included at the N.N. Petrov National Medical Research Center of Oncology. Sixty-seven (70 %) patients had stage IV M1c, 35 patients (36 %) had elevated LDH before initiating IPI therapy. All patients received IPI 3 mg / kg IV every 3 weeks for a maximum of 4 cycles. Totally, 320 cycles (mean - 3.3 per patient) were conducted. Grade 3-4 immuno-mediated adverse events (imAE) observed in 18 (19 %) patients. Three patients died of adverse events, possibly associated with ongoing therapy. The median time to progression was 3 (95 % CI, 2.4 to 3.5) mo., the median overall survival was 13 (95 % CI, 8.3 to17.6) mo. Previous immunotherapy with dendritic cell vaccines decreased the risk of death by 48 % (Log-rank p = 0.049). The wild type BRAF status increased three-year overall survival from 29 to 68 % (p = 0.042). Our data confirms long-term safety and efficacy of IPI in patients with pretreated disseminated melanoma in the close to real practice setting. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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