CLINICAL AND IMMUNOLOGICAL STUDY OF RECOMBINANT GAMMA – INTERFERON (rHuIFN-γ, INGARON) IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH METASTATIC SKIN MELANOMA.
 
Mikhail E. Abramov, Elena G. Slavina, Sergey L. Gutorov,  Antonina I. Chertkova, Esma K. Shoua, Hibla A. Biguava, Venera A.Nurtdinova. Anna A. Borunova, Alla J. Mashchelueva, Zaira G. Kadagidze, Mikhail R. Lichinitser
RUSSIAN CANCER RESEARCH CENTER, Moscow
 
Clinical and immunological study of combination of recombinant γ – interferon (rHuIFN-g, Ingaron, Pharmaclone. Russia) and chemotherapy for the treatment of disseminated skin melanoma was done.
Materials and methods.
58 metastasis skin melanoma patients were treated with chemotherapy and rHuIFN-g (Ingaron). A regimen of treatment included rHuIFN-g on 500 000 IU sc on days 1 - 5 before chemotherapy, dacarbazine 250mg/m2 on days 6-8, lomustine 80mg/m2 on day 6, cisplatin 80mg/m2 on day 8. rHuIFN-g (Ingaron) treatment was used 3 times per week sc between the chemotherapy cycles. Cycles were repeated every 5 weeks.
Results. A clinical and immunological data was evaluated in 56 patients (26 – female, 30 - male). Median age was 53,5 years. 233 cycles of chemotherapy were administered (range 1 - 10). Efficacy was evaluated in 56 patients (26 patients with visceral metastases and 30 patients with soft tissue and lymph node metastases). Objective response was achieved in 39,3% patients (complete response – 14,3%), disease control (CR + PR + SD ≥ 6 months) – 58,9%. At 14 patients with effect (soft tissue and lymph node metastases), operative treatment has been performed.
Follow-up time was 39 months. Median time to progression (TTP) was 8,6 months and median overall survival (OS) 12,6 months (56 pts.).
Median time to progression and overall survival (n=56)

 
n (%)
TTP, median (mo.)
OS, median (mo.)
CR
8 (14,3)
not achieved
not achieved
PR
14 (25)
12,1
17,0
SD ≥ 4 mo
18 (32,1)
6,0
8,6
SD ≥ 6 mo
11 (19,6)
8,1
11,3
CR + PR + SD (≥4 mo)
40(71,4)
12,0
16,6
CR + PR + SD (≥6 mo)
33 (58,9)
13,4
21,2
PD
16 (28,5)
2,4
6,5
 
CR + PR + SD (≥6 mo) without operation
19
12,2
15,2
CR + PR + SD (≥6 mo) with operation
14
30,0
36,4

 
The analysis of subpopulation of peripheral blood T-lymphocytes showed an increasing of proportion of CD5+ cells and normalization of quantity of CD3+, CD25+ and HLA-DR+ cells. The quantity of CD16+ lymphocytes decreased coincidentally with activation of their cytotoxic potency, but only in the patients with antitumor response. This effect was not found in control group (chemotherapy without Ingaron). CD16+ proportion was normalized without elevation of the cytolytic potency in patient with progression of the disease. It was performed the study of the proportion of CD4+CD25+FOXP3+ lymfocytes (Treg cells). We found the decreasing of the number of Treg cells, but it was some difference between the patients with clinical effects or disease stabilization and progressing patients: whereas in first group of patients occurs real decreasing of the proportion of CD4+CD25+FOXP3+ cells without the changing of the populations CD4+ or CD25+ cells, the reduction of the number Treg cells was depended on the decreasing of the CD25+ population in the patients with disease progression.  
Conclusion.  Combination of Ingaronplus chemotherapy has high efficacy in metastatic skin melanoma patients. The best results on the time to disease progressionand overall survival were obtained in the effectively treated patients. Ingaron shows evidence of significant immunomodulating activity especially regarding of the proportion of Treg cells.
 
 
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Отчет. Влияние Рефнота® на иммунитет у онкологических больных (Российский Онкологический Научный Центр им. Н.Н. Блохина)

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