title: A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer.
abstract: This multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN).
  
  
  
  Seventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 μg/m2/day for up to 10 days or a single subcutaneous injection of DA-3031 at fixed doses of 6 mg on day 2 of each chemotherapy cycle.
  
  
  
  The mean duration of grade 4 (G4) neutropenia in cycle 1 was 2.08 ± 0.85 days for the filgrastim group and 2.28 ± 1.14 days for the DA-3031 group. The difference between groups was 0.2 ± 1.10 days (95 % confidence interval (CI) = -0.26, 0.66), which supported non-inferiority. No statistically significant differences were observed in nadir absolute neutrophil count (ANC) (154.34/mm3and 161.75/mm3for the filgrastim and DA-3031 groups, respectively; P = 0.8414) or in time to ANC recovery (10.03 ± 0.75 and 9.83 ± 1.56 days in the filgrastim and DA-3031 groups, respectively; P = 0.0611) during cycle 1. Serious AEs occurred in six (15.8 %) patients receiving filgrastim and in ten (27.8 %) patients receiving DA-3031; however, none was determined to be related to the study drug.
  
  
  
  DA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy.
authors.affiliation: Division of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, 73 Inchonro, Sungbuk-Gu, Seoul, 02481, South Korea.
authors.forename: K H
authors.initials: KH
authors.lastname: Park
authors.affiliation: Division of Oncology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
authors.forename: S
authors.initials: S
authors.lastname: Lee
authors.affiliation: Division of Oncology/Hematology, Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, South Korea.
authors.forename: J H
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
authors.forename: S Y
authors.initials: SY
authors.lastname: Kang
authors.affiliation: Division of Oncology/Hematology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Pyeongchon, Anyang-si, Gyeonggi-do, South Korea.
authors.forename: H Y
authors.initials: HY
authors.lastname: Kim
authors.affiliation: Center for Breast Cancer and Center for Clinical Trials, National Cancer Center, Goyang-si, South Korea.
authors.forename: I H
authors.initials: IH
authors.lastname: Park
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Samsung Medical Center, Seoul, South Korea.
authors.forename: Y H
authors.initials: YH
authors.lastname: Park
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Samsung Medical Center, Seoul, South Korea.
authors.forename: Y H
authors.initials: YH
authors.lastname: Im
authors.affiliation: Product Development HQ, Dong-A ST, Seoul, South Korea.
authors.forename: H J
authors.initials: HJ
authors.lastname: Lee
authors.affiliation: Division of Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine, Seoul, South Korea.
authors.forename: S
authors.initials: S
authors.lastname: Park
authors.affiliation: Division of Oncology/Hematology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
authors.forename: S I
authors.initials: SI
authors.lastname: Lee
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: K H
authors.initials: KH
authors.lastname: Jung
authors.affiliation: Division of Oncology/Hematology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, South Korea.
authors.forename: Y S
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Division of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, 73 Inchonro, Sungbuk-Gu, Seoul, 02481, South Korea. cancer@korea.ac.kr.
authors.forename: Jae Hong
authors.initials: JH
authors.lastname: Seo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage* / Q000009:adverse effects; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; C486981:pegylated granulocyte colony-stimulating factor, human; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D011092:Polyethylene Glycols; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069585:Filgrastim
keywords: Breast cancer; Neutropenia; Pegylated G-CSF; TAC chemotherapy