A randomized multi-center phase II trial of capecitabine (X) versus S-1 (S) as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

Abstract

4546 Background: Although the combination chemotherapy is the standard of care for young patients (pts) with advanced gastric cancer (AGC), single agent chemotherapy may be a good alternative for elderly pts. Recent introduction of two new generation oral fluoropyrimidines, capecitabine and S-1, prompted us to investigate the activity and safety of these agents in elderly pts with AGC in a randomized multi-center phase II design. ( NCT00278863 ) Methods: Elderly chemo-naïve pts (= 65 years) with measurable metastatic or recurrent gastric cancer were randomly assigned to receive capecitabine (1,250 mg/m 2 bid, D1–14 every 3 weeks, arm X) or S-1 (40∼60 mg bid according to BSA, D1–28 every 6 weeks, arm S). The primary endpoint was the response rate (RR). Results: From Oct 2004 to Apr 2006, 96 pts were enrolled. Excluding 5 pts who did not fit inclusion criteria, 91 pts were randomized to arm X (N=46) or arm S (N=45). Median age was 70.5 years for arm S and 71.0 years for arm X. Other clinical and tumor characteristics were well balanced across the two treatment arms. Among 44 assessable pts in arm X, 13 attained partial response (PR, 29.5%), 17 stable disease (SD, 38.6%) and 10 progressive disease (PD); 4 pts were not evaluable (NE). The corresponding disease responses in the 45 assessable pts in arm S were: 1 complete response (2.2%), 12 PR (26.7%), 18 SD (40.0%), 10 PD, and 4 NE. The incidence of grade 3–4 granulocytopenia was 6.8% in arm X and 4.8% in arm S. One episode of febrile neutropenia was observed in arm X. Grade 3–4 non-hematologic toxicities were as follows (arm X vs. S): asthenia (0% vs. 7.2%), anorexia (6.8% vs. 9.5%), diarrhea (2.3% vs. 0%), and HFS (6.8% vs. 0%). With a median follow up of 13.5 months (mo) for survivors (range, 8.1∼21.9), median time to progression and time to treatment failure were 4.8 mo (95% CI, 3.0–6.5) and 4.4 mo (3.6–5.3) for arm X and 4.2 mo (1.5–6.9) and 3.0 mo (1.5–4.5) for arm S. Median overall survival was 10.0 mo (8.0–12.0) for arm X and 7.9 mo (4.1–11.7) for arm S. Conclusions: Both treatments were active and tolerable as a 1 st line treatment for elderly pts with AGC. No significant financial relationships to disclose.