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Dose response of pegfilgrastim in Japanese breast cancer patients receiving six cycles of docetaxel, doxorubicin, and cyclophosphamide therapy: a randomized controlled trial.

AbstractPURPOSE:
A phase II, open-label, dose-finding, randomized study was performed to evaluate the recommended dose of pegfilgrastim in Japanese breast cancer patients.
METHODS:
Patients received 1.8, 3.6, or 6.0 mg of pegfilgrastim once per chemotherapy cycle for up to 6 cycles. Patients received docetaxel, doxorubicin, and cyclophosphamide (TAC) therapy followed by pegfilgrastim on the next day.
RESULTS:
Pegfilgrastim was administered to 87 women with stage II/III invasive breast carcinoma. The duration of grade 4 neutropenia in the first cycle, the primary endpoint, was 2.2 ± 0.9 days, 1.5 ± 0.9 days, and 1.4 ± 0.7 days in the 1.8, 3.6, and 6.0 mg groups, respectively. This finding indicated that pegfilgrastim efficacy peaked at 3.6 mg. Pegfilgrastim doses up to 6.0 mg were considered safe.
CONCLUSION:
A 3.6-mg pegfilgrastim dose may be safe and effective for Japanese patients. A confirmatory study is required to establish safety and efficacy at this dose for intensive anti-cancer chemotherapy.
AuthorsNorikazu Masuda, Yutaka Tokuda, Seigo Nakamura, Ryutaro Shimazaki, Yoshinori Ito, Kazuo Tamura
JournalSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 23 Issue 10 Pg. 2891-8 (Oct 2015) ISSN: 1433-7339 [Electronic] Germany
PMID25733000 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Recombinant Proteins
  • Taxoids
  • Granulocyte Colony-Stimulating Factor
  • Docetaxel
  • pegfilgrastim
  • Polyethylene Glycols
  • Doxorubicin
  • Cyclophosphamide
  • Filgrastim
Topics
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • Asian People
  • Breast Neoplasms (blood, drug therapy, mortality, pathology)
  • Cyclophosphamide (administration & dosage, therapeutic use)
  • Docetaxel
  • Doxorubicin (administration & dosage, therapeutic use)
  • Drug Administration Schedule
  • Female
  • Filgrastim
  • Granulocyte Colony-Stimulating Factor (administration & dosage, metabolism, therapeutic use)
  • Humans
  • Middle Aged
  • Neutropenia (chemically induced)
  • Polyethylene Glycols
  • Recombinant Proteins (administration & dosage, therapeutic use)
  • Taxoids (administration & dosage, therapeutic use)

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