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Supportive Care in Cancer
Published in: Supportive Care in Cancer 10/2015

Open Access 01-10-2015 | Original Article

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

Authors: Norikazu Masuda, Yutaka Tokuda, Seigo Nakamura, Ryutaro Shimazaki, Yoshinori Ito, Kazuo Tamura

Published in: Supportive Care in Cancer | Issue 10/2015

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Abstract

Purpose

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.
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Metadata
Title
Dose response of pegfilgrastim in Japanese breast cancer patients receiving six cycles of docetaxel, doxorubicin, and cyclophosphamide therapy: a randomized controlled trial
Authors
Norikazu Masuda
Yutaka Tokuda
Seigo Nakamura
Ryutaro Shimazaki
Yoshinori Ito
Kazuo Tamura
Publication date
01-10-2015
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 10/2015
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-015-2654-4

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