PMID- 33191320
OWN - NLM
STAT- MEDLINE
DCOM- 20210416
LR  - 20210519
IS  - 1349-7235 (Electronic)
IS  - 0918-2918 (Print)
IS  - 0918-2918 (Linking)
VI  - 60
IP  - 8
DP  - 2021 Apr 15
TI  - A Multicenter Study of Docetaxel at a Dose of 100 mg/m(2) in Japanese Patients 
      with Advanced or Recurrent Breast Cancer.
PG  - 1183-1190
LID - 10.2169/internalmedicine.5089-20 [doi]
AB  - Objective This study examined the pharmacokinetics, safety and anti-tumor 
      activity of docetaxel at a dose of 100 mg/m(2) 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/m(2) 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, 
      gamma-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 mug・hr/mL (mean), respectively. Conclusion Docetaxel at a 
      dose of 100 mg/m(2) 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.
FAU - Hirata, Taizo
AU  - Hirata T
AD  - Department of Medical Oncology, National Hospital Organization Kure Medical 
      Center and Chugoku Cancer Center, Japan.
FAU - Ozaki, Shinji
AU  - Ozaki S
AD  - Department of Breast Surgery, National Hospital Organization Kure Medical Center 
      and Chugoku Cancer Center, Japan.
FAU - Tabata, Masahiro
AU  - Tabata M
AD  - Departments of Allergy and Respiratory Medicine, Okayama University Hospital, 
      Japan.
FAU - Iwamoto, Takayuki
AU  - Iwamoto T
AD  - Departments of Breast and Endocrine Surgery, Okayama University Hospital, Japan.
FAU - Hinotsu, Shiro
AU  - Hinotsu S
AD  - Department of Biostatistics, Sapporo Medical University, Japan.
FAU - Hamada, Akinobu
AU  - Hamada A
AD  - Division of Clinical Pharmacology & Translational Research, Exploratory Oncology 
      Research & Clinical Trial Center, National Cancer Center, Japan.
FAU - Motoki, Takayuki
AU  - Motoki T
AD  - Department of Surgery, Okayama Saiseikai General Hospital, Japan.
FAU - Nogami, Tomohiro
AU  - Nogami T
AD  - Department of Surgery, Tsuyama Chuo Hospital, Japan.
FAU - Shien, Tadahiko
AU  - Shien T
AD  - Departments of Breast and Endocrine Surgery, Okayama University Hospital, Japan.
FAU - Taira, Naruto
AU  - Taira N
AD  - Departments of Breast and Endocrine Surgery, Okayama University Hospital, Japan.
FAU - Matsuoka, Junji
AU  - Matsuoka J
AD  - Departments of Breast and Endocrine Surgery, Okayama University Hospital, Japan.
FAU - Doihara, Hiroyoshi
AU  - Doihara H
AD  - Departments of Breast and Endocrine Surgery, Okayama University Hospital, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20201116
PL  - Japan
TA  - Intern Med
JT  - Internal medicine (Tokyo, Japan)
JID - 9204241
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols
MH  - *Breast Neoplasms/drug therapy
MH  - Docetaxel/therapeutic use
MH  - Drug Administration Schedule
MH  - Humans
MH  - Japan/epidemiology
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - Taxoids/therapeutic use
PMC - PMC8112988
OTO - NOTNLM
OT  - 100 mg/m2
OT  - Japanese
OT  - advanced or recurrent cancer
OT  - docetaxel
OT  - phase I study
COIS- Author's disclosure of potential Conflicts of Interest (COI). Taizo Hirata: 
      Honoraria, Eisai. Hiroyoshi Doihara: Research funding, Kyowa Hakko Kirin.
EDAT- 2020/11/17 06:00
MHDA- 2021/04/17 06:00
PMCR- 2021/04/15
CRDT- 2020/11/16 05:57
PHST- 2020/11/17 06:00 [pubmed]
PHST- 2021/04/17 06:00 [medline]
PHST- 2020/11/16 05:57 [entrez]
PHST- 2021/04/15 00:00 [pmc-release]
AID - 10.2169/internalmedicine.5089-20 [doi]
PST - ppublish
SO  - Intern Med. 2021 Apr 15;60(8):1183-1190. doi: 10.2169/internalmedicine.5089-20. 
      Epub 2020 Nov 16.