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

Abstract

Background: 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. Methods: We analyzed 5-year disease-free survival of patients recruited into the trial. Results: 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 %. Conclusions: 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. Trial registration: ClinicalTrials.gov NCT02115984 from 04/07/2014.