title: Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer.
abstract: OBJECTIVE
  The taxanes and capecitabine have synergistic antitumor activity in preclinical models. This trial was designed to determine the efficacy and tolerability of weekly paclitaxel plus capecitabine as first-line treatment for metastatic breast cancer (MBC).
  
  
  METHODS
  Participants had histologically proven breast cancer, with measurable metastatic disease by Response Evaluation Criteria in Solid Tumors Group. Exclusion criteria included prior taxane therapy or any prior capecitabine or infusional fluorouracil. Participants received capecitabine 825 mg/m2/dose orally bid (1,650 mg/m2/d) for days 1 to 14. Paclitaxel 80 mg/m2 was administered intravenously weekly on days 1 and 8. Cycles were repeated every 3 weeks. Responders (complete or partial) or those with stable disease were treated until progression of disease or intolerable toxicity.
  
  
  RESULTS
  Fifty-five women were enrolled; 94% received study therapy as first-line treatment for MBC. In the intent-to-treat population, objective responses (partial) were achieved in 30 patients (55%; 95% CI, 40% to 69%), and six additional patients had stable disease for 6 months or longer (clinical benefit rate of 65%). The median duration of response was 10 months (range, 2.5 to 18.7 months). Dose modifications and reductions were common, particularly for capecitabine, leading to a delivered dose-intensity of 75% for capecitabine and 91% for paclitaxel. The most frequent grade 3 to 4 treatment-related adverse events were hand-foot skin reaction (n = 10); neutropenia (n = 7); fatigue (n = 4); and leukopenia, diarrhea, and pain (n = 3 each).
  
  
  CONCLUSIONS
  Capecitabine in combination with weekly paclitaxel is an active and tolerable regimen as first-line therapy for women with MBC.
authors.affiliation: US Oncology Research Inc, Houston, USA. joanne.blum@usoncology.com
authors.forename: Joanne L
authors.initials: JL
authors.lastname: Blum
authors.forename: E Claire
authors.initials: EC
authors.lastname: Dees
authors.forename: Aparna
authors.initials: A
authors.lastname: Chacko
authors.forename: Lisa
authors.initials: L
authors.lastname: Doane
authors.forename: Sukumar
authors.initials: S
authors.lastname: Ethirajan
authors.forename: Judith
authors.initials: J
authors.lastname: Hopkins
authors.forename: Richard
authors.initials: R
authors.lastname: McMahon
authors.forename: Suzan
authors.initials: S
authors.lastname: Merten
authors.forename: Angel
authors.initials: A
authors.lastname: Negron
authors.forename: Marcus
authors.initials: M
authors.lastname: Neubauer
authors.forename: Des
authors.initials: D
authors.lastname: Ilegbodu
authors.forename: Kristi A
authors.initials: KA
authors.lastname: Boehm
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
authors.forename: Joyce A
authors.initials: JA
authors.lastname: O'Shaughnessy
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, 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 / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil