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.
abstract: 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.
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia.
authors.forename: Anastasia S
authors.initials: AS
authors.lastname: Proskurina
authors.affiliation: Novosibirsk State Medical University, Novosibirsk, 630091, Russia.
authors.forename: Tatiana S
authors.initials: TS
authors.lastname: Gvozdeva
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia.
authors.forename: Ekaterina A
authors.initials: EA
authors.lastname: Potter
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia.
authors.forename: Evgenia V
authors.initials: EV
authors.lastname: Dolgova
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia.
authors.forename: Konstantin E
authors.initials: KE
authors.lastname: Orishchenko
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia.
authors.forename: Valeriy P
authors.initials: VP
authors.lastname: Nikolin
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia.|Novosibirsk State University, Novosibirsk, 630090, Russia.
authors.forename: Nelly A
authors.initials: NA
authors.lastname: Popova
authors.affiliation: Novosibirsk State University, Novosibirsk, 630090, Russia.|Oncology Department of Municipal Hospital No 1, Novosibirsk, 630047, Russia.
authors.forename: Sergey V
authors.initials: SV
authors.lastname: Sidorov
authors.affiliation: Institute of Clinical Immunology, Siberian Branch of the Russian Academy of Medical Sciences, Novosibirsk, 630099, Russia.
authors.forename: Elena R
authors.initials: ER
authors.lastname: Chernykh
authors.affiliation: Institute of Clinical Immunology, Siberian Branch of the Russian Academy of Medical Sciences, Novosibirsk, 630099, Russia.
authors.forename: Alexandr A
authors.initials: AA
authors.lastname: Ostanin
authors.affiliation: Institute of Clinical Immunology, Siberian Branch of the Russian Academy of Medical Sciences, Novosibirsk, 630099, Russia.
authors.forename: Olga Y
authors.initials: OY
authors.lastname: Leplina
authors.affiliation: Irkutsk State Medical Academy of Postgraduate Education, Irkutsk, 664049, Russia.|Regional Oncology Dispensary, Irkutsk, 664035, Russia.
authors.forename: Victoria V
authors.initials: VV
authors.lastname: Dvornichenko
authors.affiliation: Irkutsk State Medical Academy of Postgraduate Education, Irkutsk, 664049, Russia.|Regional Oncology Dispensary, Irkutsk, 664035, Russia.
authors.forename: Dmitriy M
authors.initials: DM
authors.lastname: Ponomarenko
authors.affiliation: Novosibirsk State University, Novosibirsk, 630090, Russia.|Clinic Department of the Central Clinical Hospital, Siberian Branch of the Russian Academy of Sciences, Novosibirsk, 630090, Russia.
authors.forename: Galina S
authors.initials: GS
authors.lastname: Soldatova
authors.affiliation: CJSC "Vector-best", Koltsovo, Novosibirsk Region, 630559, Russia.
authors.forename: Nikolay A
authors.initials: NA
authors.lastname: Varaksin
authors.affiliation: CJSC "Vector-best", Koltsovo, Novosibirsk Region, 630559, Russia.
authors.forename: Tatiana G
authors.initials: TG
authors.lastname: Ryabicheva
authors.affiliation: Mercer University School of Medicine, Macon, GA, 31207, USA.
authors.forename: Peter N
authors.initials: PN
authors.lastname: Uchakin
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia.
authors.forename: Vladimir A
authors.initials: VA
authors.lastname: Rogachev
authors.affiliation: LLC "Panagen", Gorno-Altaisk, 649000, Russia.
authors.forename: Mikhail A
authors.initials: MA
authors.lastname: Shurdov
authors.affiliation: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences, 10 Lavrentieva Ave, Novosibirsk, 630090, Russia. labmolbiol@mail.ru.
authors.forename: Sergey S
authors.initials: SS
authors.lastname: Bogachev
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D005260:Female; D006801:Humans; D009367:Neoplasm Staging; D016019:Survival Analysis; D016896:Treatment Outcome
keywords: AC chemotherapy; Breast cancer; CD8 + perforin + T cells; Disease-free survival; FAC chemotherapy; dsDNA