Vol. 64 No. 3 (2018), ORIGINAL ARTICLES. A. PROTOCOLS OF CLINICAL RESEARCH

Vol. 64 No. 3 (2018)

IPILIMUMAB IN PATIENTS WITH DISSEMINATED MELANOMA: THE N.N. PETROV NATIONAL MEDICAL RESEARCH CENTER OF ONCOLOGY EXPANDED ACCESS PROGRAM EXPERIENCE

ORIGINAL ARTICLES. A. PROTOCOLS OF CLINICAL RESEARCH

https://doi.org/10.37469/0507-3758-2018-64-3-388-393

Published 01.03.2018

Yekaterina Anokhina⁺⁻
V. Rubinchik⁺⁻
Yekaterina Yaremenko⁺⁻
Gulfiya Teletaeva⁺⁻
Dilorom Latipova⁺⁻
Anna Semenova⁺⁻
Tatyana Semiglazova⁺⁻
Irina Baldueva⁺⁻
Svetlana Protsenko⁺⁻
Aleksey Novik⁺⁻
A. Oganesyan⁺⁻

Yekaterina Anokhina

N.N. Petrov National Medical Research Center of Oncology

V. Rubinchik

N.N. Petrov National Medical Research Center of Oncology

Yekaterina Yaremenko

St. Petersburg State Pediatric Medical University

Gulfiya Teletaeva

N.N. Petrov National Medical Research Center of Oncology

Dilorom Latipova

N.N. Petrov National Medical Research Center of Oncology

Anna Semenova

N.N. Petrov National Medical Research Center of Oncology

Tatyana Semiglazova

U. Mechnikov North-West State Medical University

Irina Baldueva

U. Mechnikov North-West State Medical University

Svetlana Protsenko

N.N. Petrov National Medical Research Center of Oncology

Aleksey Novik

N.N. Petrov National Medical Research Center of Oncology, St. Petersburg State Pediatric Medical University

A. Oganesyan

N.N. Petrov National Medical Research Center of Oncology

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Keywords

IPILIMUMAB
MELANOMA
EFFICACY
ADVERSE EVENTS
PROGNOSTIC AND PREDICTIVE MARKERS

How to Cite

Anokhina, Y., Rubinchik, V., Yaremenko, Y., Teletaeva, G., Latipova, D., Semenova, A., Semiglazova, T., Baldueva, I., Protsenko, S., Novik, A., & Oganesyan, A. (2018). IPILIMUMAB IN PATIENTS WITH DISSEMINATED MELANOMA: THE N.N. PETROV NATIONAL MEDICAL RESEARCH CENTER OF ONCOLOGY EXPANDED ACCESS PROGRAM EXPERIENCE. Voprosy Onkologii, 64(3), 388–393. https://doi.org/10.37469/0507-3758-2018-64-3-388-393

Abstract

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.

https://doi.org/10.37469/0507-3758-2018-64-3-388-393

##article.numberofdownloads## 46

##article.numberofviews## 156

PDF (Русский)

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