Background: The efficacy and safety of the combination of capecitabine (X) and cisplatin (P) in the treatment of advanced gastric cancer (AGC) have already been shown in several prospective clinical trials. In this study, we sought to evaluate the efficacy and feasibility of the XP combination for the treatment of AGC in clinical practice and to determine the prognostic factors affecting treatment outcomes.
Methods: Clinical data from 223 patients with previously untreated metastatic, unresectable, or recurrent gastric carcinoma who were treated with XP between March 2000 and December 2004 at a single center were reviewed. Each 3-week chemotherapy cycle consisted of oral capecitabine (1000-1250 mg/m2 twice a day on days 1-14) and i.v. cisplatin (60-80 mg/m2 on day 1).
Results: Of the 223 patients, 32 had distant metastases but palliative gastrectomy (resected metastatic), 82 had recurrent disease after previous curative gastrectomy (recurrent), and 109 had distant metastases without gastrectomy (initially metastatic). Patients received a median of five cycles of chemotherapy (range, 1-12 cycles). Among the 123 patients with measurable disease, seven achieved complete responses and 49 had partial responses, giving an overall response rate (RR) of 45.5% in the intention-to-treat population (95% CI, 32.9-50.2%). There were no differences in RR among the groups of resected metastatic, recurrent and initially metastatic patients (66.7 versus 36.5 versus 50.8%, P = 0.35). After a median follow-up of 11.9 months (range, 2.1-51.9 months), the median time to progression (TTP) was 6.3 months (95% CI, 5.2-7.4 months) and the median overall survival (OS) was 11.1 months (95% CI, 9.4-12.9 months). In the resected metastatic, recurrent and initially metastatic groups, TTP was 8.7, 6.8 and 5.8 months (P = 0.02) and median OS was 14.7, 12.4 and 9.6 months (P = 0.03), respectively. Multivariate analysis showed that relatively small tumor burden (resected metastatic or recurrent versus initially metastatic groups) (OR = 1.418, 95% CI, 1.021-1.967, P = 0.037) and good performance status (ECOG 0-1 versus 2) (OR = 3.800, 95% CI, 2.417-5.974, P < 0.001) were independent prognostic factors affecting overall survival.
Conclusion: The combination of capecitabine and cisplatin was active and well tolerated as a first line treatment of AGC in general clinical practice. Disease status and performance status of the patients were the most important factors in treatment outcomes.