title: Phase II study of weekly docetaxel and capecitabine in patients with metastatic breast cancer.
abstract: OBJECTIVE
  This phase II study evaluated the safety and efficacy of weekly docetaxel and capecitabine in patients with metastatic breast cancer.
  
  
  METHODS
  Thirty-nine patients with metastatic breast cancer received 30 mg/m2 of docetaxel on days 1, 8, and 15 in combination with capecitabine 800 mg/m2 twice daily on days 1-21, repeated every 28 days.
  
  
  RESULTS
  The median number of treatment cycles was 4 (range, 1-20 cycles). Grade 3 toxicities per patient were asthenia (n = 7; 18%), diarrhea (n = 7; 18%), nausea/vomiting (n = 5; 13%), stomatitis (n = 5; 13%), neutropenia (n = 5; 13%), and hand-foot syndrome (n = 4; 10%). There were only 2 grade 4 toxicities, febrile neutropenia and pulmonary embolism. The overall response rate was 44% (95% confidence interval (CI), 28%-60%), median duration of response was 9.1 months (95% CI, 6.2-12 months), and median time to progression was 5.5 months (95% CI, 3.7-7.3 months).
  
  
  CONCLUSIONS
  Weekly docetaxel with capecitabine was active with acceptable toxicities. Additional trials to define the optimal schedule of docetaxel and capecitabine are justified.
authors.affiliation: Division of Hematology and Oncology, Comprehensive Cancer Center, Ohio State University Medical Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, OH, USA.
authors.forename: Ewa
authors.initials: E
authors.lastname: Mrozek
authors.forename: Bhuvaneswari
authors.initials: B
authors.lastname: Ramaswamy
authors.forename: Donn
authors.initials: D
authors.lastname: Young
authors.forename: Chris A
authors.initials: CA
authors.lastname: Rhoades
authors.forename: Kari
authors.initials: K
authors.lastname: Kendra
authors.forename: Joan
authors.initials: J
authors.lastname: Allen
authors.forename: Tim
authors.initials: T
authors.lastname: Moore
authors.forename: Marsha
authors.initials: M
authors.lastname: Hauger
authors.forename: Holly
authors.initials: H
authors.lastname: Watson
authors.forename: Nancy
authors.initials: N
authors.lastname: Merriman
authors.forename: Padma
authors.initials: P
authors.lastname: Nadella
authors.forename: Miguel
authors.initials: M
authors.lastname: Villalona-Calero
authors.forename: Charles L
authors.initials: CL
authors.lastname: Shapiro
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D000069287:Capecitabine; 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 / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil