Capecitabine (X) combined with fractionated cisplatin (C) as first-line therapy in Chinese patients (pts) with advanced gastric carcinoma (AGC)

Abstract

4053 Background: Gastric cancer is one of the most common malignancies in China with a mortality rate of 25.16/100,000 population. Combination of 5-FU and fractionated C is a standard treatment for AGC in China. In a Korean study by Kim et al., X + C produced a response rate of 55% in pts with previously untreated AGC. Therefore, we evaluated the activity and safety of the combination of X and C in Chinese pts with AGC. Methods: 154 pts were enrolled between Jun 2002 and Aug 2004. All had measurable AGC (WHO), Karnofsky performance status ≥60, adequate bone marrow, renal and hepatic functions. Prior radiotherapy or adjuvant chemotherapy was permitted. Pts received X 1000mg/m2 orally bid on days 1–14 + C 20mg/m2/day i.v. on days 1–5, every 3 weeks for 6 cycles. Results: 141 pts are evaluable. The remaining 13 pts are not evaluable because they are still receiving treatment. Baseline characteristics: 104 men and 37 women; median age 54 years (range 23–80). Main sites of metastases were: lymph nodes 45%, liver 40%, stomach 18%, skin 6%, lung 5%, abdomen 4%, other 6%. The median treatment duration is currently 6 cycles (range 3–6). Efficacy findings are shown in the table. Median progression-free and overall survival have not yet been reached. The most common treatment-related adverse events (grade 1/2) were: hand-foot syndrome (HFS) 23%, leucopenia 13%, and SGOT abnormality 12%. The most common grade 3 adverse event were SGPT abnormality 3%, HFS 2%, and anemia 2%. There were no grade 4 adverse events. Most grade 3 adverse events improved or resolved after treatment or interruption except in 1 pt with anemia who withdrew after 2 cycles. Conclusions: X combined with fractionated C is highly active and very well tolerated as first-line treatment for AGC, with comparable results to 5-FU + C. No significant financial relationships to disclose.