A phase II study of paclitaxel and capecitabine as a first-line combination chemotherapy for advanced gastric cancer

Paclitaxel and capecitabine, which have distinct mechanisms of action and toxicity profiles, have each shown high activity as single agents in gastric cancer. Synergistic interaction between these two drugs was suggested by taxane-induced upregulation of thymidine phosphorylase. We, therefore, evaluated the antitumour activity and toxicities of paclitaxel and capecitabine as first-line therapy in patients with advanced gastric cancer (AGC). Patients with histologically confirmed unresectable or metastatic AGC were treated with capecitabine 825 mg m−2 p.o. twice daily on days 1–14 and paclitaxel 175 mg m−2 i.v. on day 1 every 3 weeks until disease progression or unacceptable toxicities. Between June 2002 and May 2004, 45 patients, of median age 57 years (range=38–73 years), were treated with the combination of capecitabine and paclitaxel. After a median 6 cycles (range=1–9 cycles) of chemotherapy, 43 were evaluable for toxicity and response. A total of 2 patients showed complete response and 20 showed partial response making the overall response rate 48.9% (95% CI=30.3–63.5%). After a median follow-up of 42.2 months (range=31.2–54.3 months), median time to progression was 5.6 months (95% CI=3.9–7.2 months) and median overall survival was 11.3 months (95% CI=8.1–14.4 months). Grade 3 or 4 adverse events include neutropaenia (46.5% of patients), hand–foot syndrome (9.3%), arthralgia (9.3%), and asthenia (4.7%). There was no neutropaenic fever or treatment-related deaths. Paclitaxel and capecitabine combination chemotherapy was active and highly tolerable as a first-line therapy for AGC.