Docetaxel and capecitabine for advanced gastric cancer: investigating dose-dependent efficacy in two patient cohorts

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. Conclusion: 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.