Results of multicenter double-blind placebo-controlled phase II clinical trial of Panagen preparation to evaluate its leukostimulatory activity and formation of the adaptive immune response in patients with stage II-IV breast cancReportar como inadecuado




Results of multicenter double-blind placebo-controlled phase II clinical trial of Panagen preparation to evaluate its leukostimulatory activity and formation of the adaptive immune response in patients with stage II-IV breast canc - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Cancer

, 15:122

Clinical oncology

Abstract

BackgroundWe performed a multicenter, double-blind, placebo-controlled, phase II clinical trial of human dsDNA-based preparation Panagen in a tablet form. In total, 80 female patients with stage II-IV breast cancer were recruited.

MethodsPatients received three consecutive FAC 5-fluorouracil, doxorubicin and cyclophosphamide or AC doxorubicin and cyclophosphamide adjuvant chemotherapies 3 weeks per course and 6 tablets of 5 mg Panagen or placebo daily one tablet every 2–3 hours, 30 mg-day for 18 days during each chemotherapy course. Statistical analysis was performed using Statistica 6.0 software, and non-parametric analyses, namely Wilcoxon-Mann–Whitney and paired Wilcoxon tests. To describe the results, the following parameters were used: number of observations n, median, interquartile range, and minimum-maximum range.

ResultsPanagen displayed pronounced leukostimulatory and leukoprotective effects when combined with chemotherapy. In an ancillary protocol, anticancer effects of a tablet form of Panagen were analyzed. We show that Panagen helps maintain the pre-therapeutic activity level of innate antitumor immunity and induces formation of a peripheral pool of cytotoxic CD8+ perforin + T-cells. Our 3-year follow-up analysis demonstrates that 24% of patients who received Panagen relapsed or died after the therapy, as compared to 45% in the placebo cohort.

ConclusionsThe data collected in this trial set Panagen as a multi-faceted -all-in-one- medicine that is capable of simultaneously sustaining hematopoiesis, sparing the innate immune cells from adverse effects of three consecutive rounds of chemotherapy and boosting individual adaptive immunity. Its unique feature is that it is delivered via gastrointestinal tract and acts through the lymphoid system of intestinal mucosa. Taken together, maintenance of the initial levels of innate immunity, development of adaptive cytotoxic immune response and significantly reduced incidence of relapses 3 years after the therapy argue for the anticancer activity of Panagen.

Trial registrationClinicalTrials.gov NCT02115984 from 04-07-2014.

KeywordsBreast cancer 5-fluorouracil Doxorubicin Cyclophosphamide Leukostimulation Adaptive immunity dsDNA AbbreviationsAC chemotherapyChemotherapy including doxorubicin and cyclophosphamide

dsDNADouble-stranded DNA

FAC chemotherapyChemotherapy including 5-fluorouracil, doxorubicin and cyclophosphamide

HSCsHematopoietic stem cells

PBMCsPeripheral blood mononuclear cells

Anastasia S Proskurina and Tatiana S Gvozdeva contributed equally to this work.

Electronic supplementary materialThe online version of this article doi:10.1186-s12885-015-1142-z contains supplementary material, which is available to authorized users.

An erratum to this article can be found at http:-dx.doi.org-10.1186-s12885-016-2163-y.

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Autor: Anastasia S Proskurina - Tatiana S Gvozdeva - Ekaterina A Alyamkina - Evgenia V Dolgova - Konstantin E Orishchenko - Val

Fuente: https://link.springer.com/







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