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

Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer
Norikazu MasudaKazuo Tamura

Abstract

A phase II, open-label, dose-finding, randomized study was performed to evaluate the recommended dose of pegfilgrastim in Japanese breast cancer patients. 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. 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. 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.

References

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Citations

Jun 24, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·K BlackwellN Harbeck
May 18, 2018·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Jennifer M CollinsTrevor N Christ
Nov 6, 2017·Journal of Cancer Research and Clinical Oncology·Sibylle SchirmMarkus Scholz
May 8, 2018·Annals of Surgical Treatment and Research·Jihyoun LeeCheol Wan Lim
Oct 13, 2020·Journal of Clinical Apheresis·Hideki GotoUNKNOWN North Japan Hematology Study Group (NJHSG)

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