title: A multicentre phase II study to evaluate sequential docetaxel followed by capecitabine treatment in anthracycline-pretreated HER-2-negative patients with metastatic breast cancer.
abstract: BACKGROUND
  Treatment of HER-2-negative metastatic breast cancer (MBC) patients after anthracycline exposure is controversial. Docetaxel/capecitabine is a promising regimen, but the administration schedule is not well established.
  
  
  METHODS
  Treatment included 3 cycles of docetaxel 100 mg/m2 day 1 every 21 days followed by 3 cycles of capecitabine 1250 mg/m2/12 h days 1-14. Patients not progressing were maintained with capecitabine 900 mg/m2/12 h on days 1-14 every 21 days until progression or unacceptable toxicity.
  
  
  RESULTS
  Fifty-three anthracycline-pretreated patients were enrolled: median age 54 years, ECOG grade 0-1 86.7%. Most of the women received adjuvant chemotherapy (81%) and 5 patients (9%) had had prior metastatic chemotherapy treatment. Median time from anthracycline exposure was 29 months. ORR (intent-to-treatment analysis) after the sequential therapy was 51% (CI 95% 37-65) with 15% (CI 95% 7-28) of patients reaching complete responses. Median time to progression was 8.2 (CI 95% 7.1-10.7) months, with 61.9% (CI 95% 45.6-76.4) of the patients free of disease after 6 months. Median overall survival was not reached after a median follow-up of 10.4 months, and 75% of the patients were alive after 14.3 months. Survival rate after 12 months was 81.1% (CI 95% 68.0-90.6). The most frequent NCI grade 3-4 toxicities were hair loss (28.3%), asthenia (15.1%), stomatitis (11.32%) and nausea (11.32%). Severe hand-foot syndrome rate was 7.5%.
  
  
  CONCLUSIONS
  Sequential docetaxel-capecitabine is feasible, effective and well tolerated in first-line MBC treatment. Evaluation of this schedule in randomised studies is warranted.
authors.affiliation: Servicio de Oncología Médica, Juan Ramó Jiménez Hospital, Huelva, Spain. juanbayo@yahoo.es
authors.forename: Juan
authors.initials: J
authors.lastname: Bayo
authors.forename: María
authors.initials: M
authors.lastname: Lomas
authors.forename: Javier
authors.initials: J
authors.lastname: Salvador
authors.forename: Alberto
authors.initials: A
authors.lastname: Moreno
authors.forename: Manuel
authors.initials: M
authors.lastname: Ruiz
authors.forename: Alberto
authors.initials: A
authors.lastname: Rodríguez
authors.forename: José
authors.initials: J
authors.lastname: Fuentes
authors.forename: Ana
authors.initials: A
authors.lastname: Fernández-Freire
authors.forename: Reyes
authors.initials: R
authors.lastname: Bernabé
authors.forename: Andrea
authors.initials: A
authors.lastname: Fernández
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000069287:Capecitabine; D003841:Deoxycytidine; D000077143:Docetaxel; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids