A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer

Y. S. Hong, S. Y. Song, S. I. Lee, H. C. Chung, S. H. Choi, S. H. Noh, J. N. Park, J. Y. Han, J. H. Kang, K. S. Lee, Jae Yong Cho

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Abstract

Background: Capecitabine (Xeloda®) is a novel, oral, selectively tumor-activated fluoropyrimidine with proven activity in the treatment of advanced colorectal cancer. This trial was conducted to evaluate the efficacy, safety and feasibility of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer, with a view to replacing 5-fluorouracil (5-FU) in such patients. Patients and methods: Forty-four patients received capecitabine 1250mg/m2 twice daily (2500 mg/m2/day) for 14 days followed by 7 days of rest, for up to six cycles. Results: Capecitabine produced an objective response rate of 34% (all partial responses) and stable disease in 14 patients (30%). The median time to disease progression (TTP) was 3.2 months [95% confidence interval (CI) 2.7-6.4 months] and median overall survival was 9.5 months (95% CI 6.9-13.2 months). Hand-foot syndrome (HFS), nausea, anorexia, diarrhea and vomiting were the most common adverse events. While HFS was the most frequent grade 3/4 toxicity (National Cancer Institute Common Toxicity Criteria), only 9% of patients experienced grade 3 HFS. Severe myelosuppression was not reported during the study. Conclusions: Capecitabine monotherapy is active and well tolerated as first-line therapy in patients with advanced/metastatic gastric cancer. Larger comparative trials investigating capecitabine-based combination regimens in patients with advanced gastric cancer are warranted.

Original languageEnglish
Pages (from-to)1344-1347
Number of pages4
JournalAnnals of Oncology
Volume15
Issue number9
DOIs
Publication statusPublished - 2004 Sep

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

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    Hong, Y. S., Song, S. Y., Lee, S. I., Chung, H. C., Choi, S. H., Noh, S. H., Park, J. N., Han, J. Y., Kang, J. H., Lee, K. S., & Cho, J. Y. (2004). A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. Annals of Oncology, 15(9), 1344-1347. https://doi.org/10.1093/annonc/mdh343