Phase 2 study of capecitabine and irinotecan combination chemotherapy (modified XELIRI regimen) in patients with advanced gastric cancer.
ABSTRACT The prognosis of patients with advanced gastric cancer (AGC) remains poor, and no single chemotherapy regimen is recognized as a global standard. A phase 2 trial was conducted to determine the efficacy and tolerability of the modified combination regimen of capecitabine and irinotecan (mXELIRI) in patients with AGC.
Patients with earlier untreated AGC received intravenous irinotecan (125 mg/m) over 90 minutes on days 1 and 8, and oral capecitabine (850 mg/m) twice daily on days 2 to 15, every 3 weeks. Treatment was continued for at most 8 cycles or until disease progression or intolerable toxicity.
Thirty-two patients were enrolled. In total, 141 cycles of mXELIRI were administered. The overall response rate was 43.7%, with 1 complete response and 13 partial responses. At a median follow-up of 16.2 months, median time to progression and overall survival were 5.6 months (95% confidence interval, 4.27-6.93 mo) and 11.0 months (95% confidence interval, 8.71-13.29 mo), respectively. The most common hematological adverse event was neutropenia (n=18, 56.3%); grade 3 neutropenia was observed in 5 patients, with neutropenic fever in only 2 patients. The most common grade 3/4 nonhematological toxicities were anorexia (n=3, 9.4%), nausea (n=3, 9.4%), vomiting (n=2, 6.3%), and diarrhea (n=2, 6.3%). There was no treatment-related death.
mXELIRI is a safe and effective first-line treatment for unresectable and metastatic gastric cancer with a manageable tolerability profile. It can be used as one of the first-line treatment options for patients with AGC.