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Phase II Study of Docetaxel and Capecitabine in Patients with Metastatic or Recurrent Gastric Cancer

Kim J.G.a · Sohn S.K.a · Kim D.H.a · Baek J.H.a · Sung W.J.a · Park J.Y.b · Kim T.B.b · Jung H.Y.b · Yu W.b · Lee K.B.a
Departments of aOncology/Hematology and bGeneral Surgery, Kyungpook National University Hospital, Daegu, Korea Oncology 2005;68:190–195 (DOI:10.1159/000086773)


Objectives: A phase II study was conducted to evaluate the response rate and safety of a combination regimen of docetaxel plus capecitabine in patients with advanced gastric cancer. Patients and Methods: Patients with previously untreated metastatic or recurrent measurable gastric cancer received i.v. docetaxel 75 mg/m2 on day 1 and oral capecitabine 1,000 mg/m2 twice daily from day 1 to 14 every 3-week cycle. Results: Thirty-two patients were enrolled in the current study. Of these, 30 patients were assessable for efficacy and 31 assessable for toxicity. One complete response and 13 partial responses were confirmed, giving an overall response rate of 43.8% (95% CI; 25.6–61.9%). The median time to progression and median overall survival for all patients was 5.07 months and 8.4 months, respectively. Grade 3/4 neutropenia occurred in 3 patients (9.7%) and febrile neutropenia was observed in 2 patients (6.3%). Grade 1/2 nausea was observed in 45.2% of patients. Grade 2–3 hand-foot syndrome occurred in 4 patients (12.9%). Conclusions: The combination of docetaxel and capectabine was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer.


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