• Norikazu Masuda, Yutaka Tokuda, Seigo Nakamura, Ryutaro Shimazaki, Yoshinori Ito, and Kazuo Tamura.
• Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan, nmasuda@alpha.ocn.ne.jp.
• Support Care Cancer. 2015 Oct 1; 23 (10): 2891-8.

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

30 keywords...

hide…