Five-year disease-free survival among stage II-IV breast cancer patients receiving FAC and AC chemotherapy in phase II clinical trials of Panagen

BMC Cancer

Research Article

Nikolay A. Varaksin¹  Tatiana G. Ryabicheva¹  Elena R. Chernykh²  Alexandr A. Ostanin²  Olga Y. Leplina²  Evgenia V. Dolgova³  Sergey S. Bogachev³  Valeriy P. Nikolin³  Konstantin E. Orishchenko³  Ekaterina A. Potter³  Anastasia S. Proskurina³  Vladimir A. Rogachev³  Nelly A. Popova⁴  Victoria V. Dvornichenko⁵  Dmitriy M. Ponomarenko⁵  Mikhail A. Shurdov⁶  Peter N. Uchakin⁷  Tatiana S. Gvozdeva⁸  Galina S. Soldatova⁹  Sergey V. Sidorov^1,10 

[1] CJSC “Vector-best”, 630559, Koltsovo, Novosibirsk Region, Russia;Institute of Clinical Immunology, Siberian Branch of the Russian Academy of Medical Sciences, 630099, Novosibirsk, Russia;Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, 630090, Novosibirsk, Russia;Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, 630090, Novosibirsk, Russia;Novosibirsk State University, 630090, Novosibirsk, Russia;Irkutsk State Medical Academy of Postgraduate Education, 664049, Irkutsk, Russia;Regional Oncology Dispensary, 664035, Irkutsk, Russia;LLC “Panagen”, 649000, Gorno-Altaisk, Russia;Mercer University School of Medicine, 31207, Macon, GA, USA;Novosibirsk State Medical University, 630091, Novosibirsk, Russia;Novosibirsk State University, 630090, Novosibirsk, Russia;Clinic Department of the Central Clinical Hospital, Siberian Branch of the Russian Academy of Sciences, 630090, Novosibirsk, Russia;Novosibirsk State University, 630090, Novosibirsk, Russia;Oncology Department of Municipal Hospital No 1, 630047, Novosibirsk, Russia;

关键词: Breast cancer;    FAC chemotherapy;    AC chemotherapy;    Disease-free survival;    dsDNA;    CD8 + perforin + T cells;   

DOI  :  10.1186/s12885-016-2711-5

 received in 2016-06-30, accepted in 2016-08-11,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundWe report on the results of a phase II clinical trial of Panagen (tablet form of fragmented human DNA preparation) in breast cancer patients (placebo group n = 23, Panagen n = 57). Panagen was administered as an adjuvant leukoprotective agent in FAC and AC chemotherapy regimens. Pre-clinical studies clearly indicate that Panagen acts by activating dendritic cells and induces the development of adaptive anticancer immune response.MethodsWe analyzed 5-year disease-free survival of patients recruited into the trial.ResultsFive-year disease-free survival in the placebo group was 40 % (n = 15), compared with the Panagen arm – 53 % (n = 51). Among stage III patients, disease-free survival was 25 and 52 % for placebo (n = 8) and Panagen (n = 25) groups, respectively. Disease-free survival of patients with IIIB + C stage was as follows: placebo (n = 6)–17 % vs Panagen (n = 18)–50 %.ConclusionsDisease-free survival rate (17 %) of patients with IIIB + C stage breast cancer receiving standard of care therapy is within the global range. Patients who additionally received Panagen demonstrate a significantly improved disease-free survival rate of 50 %. This confirms anticancer activity of Panagen.Trial registrationClinicalTrials.gov NCT02115984 from 04/07/2014.

【 授权许可】

CC BY   
© The Author(s). 2016