title: Phase II study of concurrent administration of doxorubicin and docetaxel as first-line chemotherapy for metastatic breast cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of concurrent administration of doxorubicin and docetaxel, without prophylactic use of granulocyte colony-stimulating factor, as first-line chemotherapy in patients with metastatic breast cancer (MBC).
  
  
  METHODS
  This multi-institutional study enrolled 40 women; 37 were assessable for efficacy and all 40 patients were evaluated for toxicity. Treatment consisted of 50 mg/m(2) doxorubicin and 60 mg/m(2) docetaxel on day 1 every 3-4 weeks.
  
  
  RESULTS
  Patients received a total of 251 cycles of chemotherapy (median, 5 cycles; range, 1-13 cycles). Of the 37 patients assessable for efficacy, 2 had a complete response and 24 had partial responses, which accounted for a 70% objective response rate (95% confidence interval, 53-84%). The median time to treatment failure was 30.1 weeks (range, 3.3-80.7 weeks). Grade 4 neutropenia was observed in 88% of patients and was the most frequent haematological toxicity. Febrile neutropenia was seen in 40% of patients, but no severe infections were observed. Non-haematological toxicity was generally tolerable. There were 2 grade 4 adverse events, which included 1 bleeding duodenal ulcer and 1 hypersensitivity reaction, but grade 3 episodes were infrequent. None of the patients developed congestive heart failure or asymptomatic decrease of left ventricular ejection fraction to less than 50%. Fluid retention syndrome <or= grade 2 was observed in 25% of patients at a median cumulative dose of docetaxel of 270 mg/m(2).
  
  
  CONCLUSIONS
  Concurrent administration of 50 mg/m(2) doxorubicin and 60 mg/m(2) docetaxel is active with a manageable toxicity profile as first-line chemotherapy for MBC.
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan. aiharat@kanrou.net
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Aihara
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Itoh
authors.forename: Yasutsuna
authors.initials: Y
authors.lastname: Sasaki
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Katsumata
authors.forename: Toru
authors.initials: T
authors.lastname: Watanabe
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
authors.forename: Noboru
authors.initials: N
authors.lastname: Horikoshi
authors.forename: Toshio
authors.initials: T
authors.lastname: Tabei
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sonoo
authors.forename: Shunkichi
authors.initials: S
authors.lastname: Hiraki
authors.forename: Hideo
authors.initials: H
authors.lastname: Inaji
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D043823:Taxoids; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin; D017239:Paclitaxel