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: 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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Authors | Norikazu Masuda, Yutaka Tokuda, Seigo Nakamura, Ryutaro Shimazaki, Yoshinori Ito, Kazuo Tamura |
Journal | Supportive 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 |
PMID | 25733000
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Recombinant Proteins
- Taxoids
- Granulocyte Colony-Stimulating Factor
- Docetaxel
- pegfilgrastim
- Polyethylene Glycols
- Doxorubicin
- Cyclophosphamide
- Filgrastim
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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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