Dataset Information

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.

SUBMITTER: Proskurina AS

PROVIDER: S-EPMC4990870 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Proskurina Anastasia S AS Gvozdeva Tatiana S TS Potter Ekaterina A EA Dolgova Evgenia V EV Orishchenko Konstantin E KE Nikolin Valeriy P VP Popova Nelly A NA Sidorov Sergey V SV Chernykh Elena R ER Ostanin Alexandr A AA Leplina Olga Y OY Dvornichenko Victoria V VV Ponomarenko Dmitriy M DM Soldatova Galina S GS Varaksin Nikolay A NA Ryabicheva Tatiana G TG Uchakin Peter N PN Rogachev Vladimir A VA Shurdov Mikhail A MA Bogachev Sergey S SS

BMC cancer 20160818

<h4>Background</h4>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.<h4>Methods</h4>We analyzed 5-year disease-free ...[more]

PMID: 27538465

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

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