title: Docetaxel and capecitabine for advanced gastric cancer: investigating dose-dependent efficacy in two patient cohorts.
abstract: BACKGROUND
  No comparisons of different doses of docetaxel-capecitabine in patients with advanced gastric cancer have been performed.
  
  
  METHODS
  Patients with previously untreated metastatic/locally advanced gastro-oesophageal or gastric adenocarcinoma were enrolled in a prospective multicentre phase II trial. Two sequential cohorts received docetaxel 75 mg m(-2) (day 1) plus capecitabine 1000 mg m(-2) twice daily (days 1-14) (cohort I) or docetaxel 60 mg m(-2) (day 1) plus capecitabine 800 mg m(-2) twice daily (days 1-14) (cohort II) every 3 weeks. The primary end point was confirmed overall response rate.
  
  
  RESULTS
  In all, 91 patients were enrolled (cohort I, n=40; cohort II, n=51) and 87 were evaluable for efficacy (n=38, 49, respectively). Overall response rate was 50.0% in cohort I and 23.5% in cohort II (exploratory analysis, P=0.014). Median times to tumour progression and overall survival were 5.6 and 10.1 months in cohort I and 3.7 and 7.2 months in cohort II, respectively. Dose reductions for docetaxel and capecitabine were required in 50.0% and 57.5% of patients in cohort I and 11.8% and 15.7% in cohort II, respectively.
  
  
  CONCLUSIONS
  Starting treatment with full doses and reducing promptly seems to be the more promisingly effective strategy than starting cautiously with lower doses. Docetaxel/capecitabine 75/2000 mg m(-2) is a manageable, convenient outpatient combination with promising efficacy against advanced gastric cancer.
authors.affiliation: Medizinische Klinik m. S. Hämatologie und Onkologie, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin 13353, Germany. peter.thuss@charite.de
authors.forename: P C
authors.initials: PC
authors.lastname: Thuss-Patience
authors.forename: A
authors.initials: A
authors.lastname: Kretzschmar
authors.forename: Y
authors.initials: Y
authors.lastname: Dogan
authors.forename: F
authors.initials: F
authors.lastname: Rothmann
authors.forename: I
authors.initials: I
authors.lastname: Blau
authors.forename: I
authors.initials: I
authors.lastname: Schwaner
authors.forename: K
authors.initials: K
authors.lastname: Breithaupt
authors.forename: D
authors.initials: D
authors.lastname: Bichev
authors.forename: M
authors.initials: M
authors.lastname: Grothoff
authors.forename: C
authors.initials: C
authors.lastname: Grieser
authors.forename: P
authors.initials: P
authors.lastname: Reichardt
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000069287:Capecitabine; D015331:Cohort Studies; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil