Capecitabine (X) combined with cisplatin (P) as 1st-line therapy in Chinese patients (pts) with advanced gastric cancer (AGC)

Abstract

4047 Background: Despite a recent fall in incidence, gastric cancer remains common in China. 5-FU plus P is a standard treatment for AGC, producing response rates of 27–51% in randomized trials, although few Chinese data are available. We evaluated the efficacy and safety of replacing the 5-FU component with X (Xeloda) as 1st-line therapy in Chinese AGC pts. Methods: We enrolled 145 pts between Jun 2002 and May 2003. All had measurable AGC (WHO), and adequate Karnofsky PS, bone marrow, renal and hepatic functions. Prior radiotherapy or adjuvant chemotherapy was permitted. Patients received capecitabine 1000 mg/m2 orally twice daily on days 1–14 plus fractionated cisplatin 20 mg/m2 i.v. on days 1–5, every 3 weeks. Results: Baseline characteristics of the 130 pts evaluable to date: 98 men, 32 women; median age 53.7 years (range 23–80); median Karnofsky PS 80 (60–100); 82% of pts had 1 metastatic site, and 18% had ≥2, the most common being the lymph nodes (44%), liver (42%), and stomach (17%). The median treatment duration is currently 6 cycles (range 2–6). Efficacy findings are shown in the table: response rate 45% (95% CI, 36–53%). Median progression-free and overall survival have not yet been reached. There were no grade 4 and very few grade 3 adverse events (all <5%): SGPT and SGOT, hand-foot syndrome, nausea, vomiting, anemia, diarrhea, anorexia, anaphylaxis. Most events were easily managed with dose adjustment and/or suitable treatments, except 1 pt with anemia who withdrew after 2 cycles. Conclusions: X combined with fractionated P is highly active and very well tolerated as first-line treatment for AGC, with comparable results to 5-FU/P. These results provide the rationale for randomized testing of the combination, although standard single infusion of P would enhance convenience. No significant financial relationships to disclose.