Naruto Taira    Department   Kawasaki Medical School  Kawasaki Medical School, Department of Breast and Thyroid Surgery,    Position   Professor
Article types	原著
Language	English
Peer review	Peer reviewed
Title	A Multicenter Study of Docetaxel at a Dose of 100 mg/m2 in Japanese Patients with Advanced or Recurrent Breast Cancer.
Journal	Formal name：Internal medicine (Tokyo, Japan) Abbreviation：Intern Med ISSN code：13497235/09182918
Domestic / Foregin	Foregin
Volume, Issue, Page	60(8),pp.1183-1190
Author and coauthor	Hirata Taizo, Ozaki Shinji, Tabata Masahiro, Iwamoto Takayuki, Hinotsu Shiro, Hamada Akinobu, Motoki Takayuki, Nogami Tomohiro, Shien Tadahiko, Taira Naruto, Matsuoka Junji, Doihara Hiroyoshi
Publication date	2021/04/15
Summary	Objective This study examined the pharmacokinetics, safety and anti-tumor activity of docetaxel at a dose of 100 mg/m2 in Japanese patients with advanced or recurrent breast cancer. Methods Japanese patients with advanced or recurrent breast cancer received docetaxel at a dose of 100 mg/m2 intravenously every three weeks. The pharmacokinetics were assessed during the first cycle. The patients were allowed to receive supportive care drugs based on the indications and dosages in Japan. Results Six eligible patients aged 39-65 years old and 27 treatment cycles were analyzed. All patients experienced one or more adverse events (AEs). The common AEs were neutropenia, thrombocytopenia, alopecia, rash, diarrhea, neuropathy (sensory), fatigue, nausea, fever, hypoalbuminemia, alanine transaminase (ALT) increased, constipation, and taste alteration. Grade 3 or 4 AEs included neutropenia, leukopenia, anemia, lymphopenia, decreased appetite, γ-glutamyl transpeptidase (GTP) increased, aspartate transaminase (AST) increased, ALT increased, hypertension and cellulitis which were all reversible. There were no cases of febrile neutropenia, serious AEs or deaths. The median number of cycles was six. Dose reductions were not observed and most cycles were administered at their intended doses. No complete response and three partial responses were observed in four assessable patients with evaluable lesions. The maximum concentration and area under the blood concentration-time curve were 3,417.5 ng/mL and 4.35 μg・hr/mL (mean), respectively. Conclusion Docetaxel at a dose of 100 mg/m2 was tolerable with acceptable safety profiles and effective for Japanese patients with advanced or recurrent breast cancer with appropriate supportive therapies, and pharmacokinetic (PK) profiles which corresponded approximately with the findings of previous clinical studies.
DOI	10.2169/internalmedicine.5089-20
PMID	33191320