T W Kim1, Y K Kang, J H Ahn, H M Chang, J H Yook, S T Oh, B S Kim, J S Lee. 1. Section of Hematology-Oncology, Department of Medicine and Department of General Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Abstract
BACKGROUND: A phase II study was conducted to assess the efficacy and tolerability of combination therapy with capecitabine and cisplatin in patients with advanced gastric cancer. PATIENTS AND METHODS: Patients with previously untreated metastatic or unresectable measurable gastric adenocarcinoma received oral capecitabine 1250 mg/m(2) twice daily, days 1-14, and i.v. cisplatin 60 mg/m(2) on day 1. This cycle was repeated every 3 weeks. RESULTS: Forty-two patients were enrolled in this study. Of these, 38 patients were assessable for efficacy and 40 were assessable for toxicity. One patient achieved a complete response and 22 patients had partial responses, giving an overall response rate of 54.8% in the intention-to-treat population (95% confidence interval 39.8% to 69.8%). The median time to progression was 6.3 months and the median overall survival was 10.1 months. The principal adverse events were neutropenia and hand-foot syndrome. Grade 3/4 adverse events were neutropenia (32.5% of patients), thrombocytopenia (10%), stomatitis (2.5%) and diarrhea (5%). Grade 2 and 3 hand-foot syndrome occurred in 20% and 7.5% of patients, respectively. There were no treatment-related deaths. CONCLUSIONS: The combination of capecitabine and cisplatin is active and well tolerated in patients with advanced gastric cancer.
BACKGROUND: A phase II study was conducted to assess the efficacy and tolerability of combination therapy with capecitabine and cisplatin in patients with advanced gastric cancer. PATIENTS AND METHODS: Patients with previously untreated metastatic or unresectable measurable gastric adenocarcinoma received oral capecitabine 1250 mg/m(2) twice daily, days 1-14, and i.v. cisplatin 60 mg/m(2) on day 1. This cycle was repeated every 3 weeks. RESULTS: Forty-two patients were enrolled in this study. Of these, 38 patients were assessable for efficacy and 40 were assessable for toxicity. One patient achieved a complete response and 22 patients had partial responses, giving an overall response rate of 54.8% in the intention-to-treat population (95% confidence interval 39.8% to 69.8%). The median time to progression was 6.3 months and the median overall survival was 10.1 months. The principal adverse events were neutropenia and hand-foot syndrome. Grade 3/4 adverse events were neutropenia (32.5% of patients), thrombocytopenia (10%), stomatitis (2.5%) and diarrhea (5%). Grade 2 and 3 hand-foot syndrome occurred in 20% and 7.5% of patients, respectively. There were no treatment-related deaths. CONCLUSIONS: The combination of capecitabine and cisplatin is active and well tolerated in patients with advanced gastric cancer.
Authors: Chul Kim; Jae-Lyun Lee; Min-Hee Ryu; Heung Moon Chang; Tae Won Kim; Ho Young Lim; Hye Jin Kang; Young Suk Park; Baek-Yeol Ryoo; Yoon-Koo Kang Journal: Invest New Drugs Date: 2009-12-09 Impact factor: 3.850