Phase II trial of XELOX as first-line treatment for patients with advanced gastric cancer.

BACKGROUND

The prognosis of patients with advanced gastric cancer (AGC) remains poor, and no single chemotherapy regimen is recognized as a global standard. A phase II trial was conducted to determine the efficacy and tolerability of capecitabine and oxaliplatin (XELOX) given every 3 weeks in combination in patients with AGC.

METHODS

Patients with previously untreated AGC received intravenous oxaliplatin 130 mg/m(2) over 2 h on day 1 plus oral capecitabine 1,000 mg/m(2) twice daily on days 1-14, every 3 weeks. Treatment was continued for 8 cycles or until disease progression or intolerable toxicity.

RESULTS

Fifty patients were enrolled. In total, 210 cycles of XELOX were delivered. The OVERALL response rate was 42% (95% CI 28.6-56.7), with 2 complete and 19 partial responses. At 15.2 months of median follow-up, median time to progression and overall survival were 5.8 (95% CI 3.4-8.2) and 11.1 (95% CI 5.6-16.5) months, respectively. The most common hematological adverse event was neutropenia (56% of patients); grade 3-4 neutropenia was observed in 6 patients, with neutropenic fever in only 2 patients. The most common non-hematological toxicities were vomiting (34%), hand-foot syndrome (26%), diarrhea (24%) and neurosensory toxicity (22%). There were no treatment-related deaths.

CONCLUSIONS

XELOX is active for the first-line treatment of AGC with a manageable tolerability profile.