Source
Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in Southern China, Guangzhou, People's Republic of China.
Abstract
OBJECTIVE:
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.
METHODS:
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.
RESULTS:
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.
CONCLUSIONS:
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.