© 2004 European Society for Medical Oncology
Original Article |
A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer
1 Department of Internal Medicine, Kangnam St Mary's Hospital; 2 Department of Internal Medicine, The Catholic University of Korea, 505 Ban-po dong, Seo Cho Gu; 3 Department of Internal Medicine and 4 Department of Surgery, Yong-Dong Severance Hospital, Yonsei University College of Medicine, Do-gok dong, Kang Nam Gu, Seoul, Korea
* Correspondence to: Dr Jae Yong Cho, Yong-Dong Severance Hospital, Yonsei University Medical College, Do-gok Dong, Kang-nam Gu, Seoul, Korea. Tel: +82-2-3497-3310; Fax: +82-2-3463-3882; Email: chojy{at}yumc.yonsei.ac.kr
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 1250 mg/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.
Key words: capecitabine, gastric cancer, metastatic, untreated
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