title: Long-term gemcitabine administration in heavily pretreated Japanese patients with metastatic breast cancer: additional safety analysis of a phase II study.
abstract: BACKGROUND
  Recently gemcitabine has been approved for treatment of metastatic or recurrent breast cancer in Japan; however, no systematically investigated safety study of long-term gemcitabine monotherapy has been reported despite its wide use globally for multiple indications.
  
  
  METHODS
  In a previously reported phase II study, 62 Japanese metastatic breast cancer patients with progressive disease after treatment with anthracyclines and taxanes were treated with gemcitabine 1250 mg/m(2) on days 1 and 8 of a 21-day cycle. For this report we re-analyzed the safety profiles for the 13 patients who received 10 or more cycles of the therapy.
  
  
  RESULTS
  Most grade 3/4 adverse events seen after 10 cycles were hematological toxicities. These were similar to those seen before the 10th cycle; however, 2 patients showed grade 3 nonhematological severe adverse events including acute cardiac failure and loss of consciousness. All adverse events were reversible and manageable. One patient received gemcitabine treatment for up to 54 cycles without unmanageable toxicities.
  
  
  CONCLUSIONS
  Toxicities seen in long-term gemcitabine treatment were reversible and manageable in this setting of heavily pretreated Japanese metastatic breast cancer patients.
authors.affiliation: Department of Breast Surgery, Hyogo Cancer Center, 13-70 Kitaouji-cho, Akashi, Hyogo, 673-8558, Japan. takao1001@gmail.com
authors.forename: Shintaro
authors.initials: S
authors.lastname: Takao
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Saeki
authors.forename: Jumpei
authors.initials: J
authors.lastname: Funai
authors.forename: Masami
authors.initials: M
authors.lastname: Ishii
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006333:Heart Failure / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D043823:Taxoids / Q000627:therapeutic use; D014474:Unconsciousness / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D000964:Antimetabolites, Antineoplastic; D043823:Taxoids; D003841:Deoxycytidine; D000093542:Gemcitabine