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

Anastasia S. Proskurina, Tatiana S. Gvozdeva, Ekaterina A. Potter, Evgenia V. Dolgova, Konstantin E. Orishchenko, Valeriy P. Nikolin, Nelly A. Popova, Sergey V. Sidorov, Elena R. Chernykh, Alexandr A. Ostanin, Olga Y. Leplina, Victoria V. Dvornichenko, Dmitriy M. Ponomarenko, Galina S. Soldatova, Nikolay A. Varaksin, Tatiana G. Ryabicheva, Peter N. Uchakin, Vladimir A. Rogachev, Mikhail A. Shurdov, Sergey S. Bogachev

We 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. We analyzed 5-year disease-free survival of patients recruited into the trial. Five-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 %. Disease-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. ClinicalTrials.gov NCT02115984 from 04/07/2014.