386P - The treatment of disseminated skin melanoma with high-dose recombinant interleukin-2 (Roncoleukin®) in combination with chemotherapy (386P)

Date 18 November 2017
Event ESMO Asia 2017 Congress
Session Poster lunch
Topics Cytotoxic agents
Skin cancers
Biological therapy
Presenter Olga Streltsova
Citation Annals of Oncology (2017) 28 (suppl_10): x113-x116. 10.1093/annonc/mdx667
Authors O. Streltsova, Y. Baranau
  • Chemotherapy, Minsk City Clinical Oncological Dispensary, 220013 - Minsk/BY



In the majority of trials evaluating immunotherapy benefit in the treatment of disseminated skin melanoma, recombinant interleukin-2 is used, which is produced by E.Coli and is not a complete analogue of human endogenous interleukin-2 molecule. Roncoleukin® (Biotech, Russia) is a complete structural and functional analogue of human endogenous interleukin-2 produced from nonpathogenic Saccharomyces cerevisiae.


Our retrospective study evaluated the results of the first-line treatment of 110 patients with disseminated skin melanoma in Minsk City Clinical Oncologic Dispansary and N.N. Alexandrov National Cancer Centre of Belarus from 2004 till 2016. According to the National standards patients received chemotherapy (dacarbazine 800 mg/m2, day 1; cisplatin 20 mg/m2, days 1–4) with supplement of one of the following immunotherapy regiments: high-dose interleukin-2 (Roncoleukin®) 9 mg/m2, days 1–5 (arm 1, n = 57) or gradual dose reduction interleukin-2 (Roncoleukin®) 18 mg/m2, day 1; 9 mg/m2, day 2; 4 mg/m2, days 3–4 (arm 2, n = 20). The control arm included patients, who received the same chemotherapy regiment without the immunotherapy (arm 3, n = 33).


The objective response rate was 35.0%, 32.5% and 19.4% in arms 1, 2 and 3 respectively. Four complete responses were registered in arm 1 only (7.0%). Because of the low amount of patients in arm 2 and the same overall response rate in arms 1 and 2 for the evaluation of progression-free survival (PFS) and overall survival the patients of arms 1 and 2 were united in one group. The median PFS was 5.5 and 3.0 (p = 0.04), the median overall survival was 12.6 and 8.2 months (p = 0.1) among the patients treated with chemoimmunotherapy and in the control arm respectively. The results of our study showed that chemoimmunotherapy for disseminated skin melanoma patients with the LDH level not exceeding more than 1.5-fold the upper reference value increased the median PFS up to 6.0 months and the median overall survival up to 14.5 months.


Our experience confirmed that immunochemotherapy with high-dose interleukin-2 (Roncoleukin®) is an effective treatment of disseminated skin melanoma and is satisfactily tolerated.

Clinical trial identification

Legal entity responsible for the study

Department of Oncology of the Belarusian Medical Academy of Postgraduate Education




All authors have declared no conflicts of interest.