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Open Access 01-12-2016 | Research article

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

Authors: 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

Published in: BMC Cancer | Issue 1/2016

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.

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Title: Five-year disease-free survival among stage II-IV breast cancer patients receiving FAC and AC chemotherapy in phase II clinical trials of Panagen
Authors: 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
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: BMC Cancer / Issue 1/2016
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-016-2711-5

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Abstract

Background

Methods

Results

Conclusions

Trial registration

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