A Phase II Study of Irinotecan With Biweekly, Low Dose Leucovorin and Bolus and Continuous Infusion 5-Fluorouracil (Modified FOLFIRI) as First Line Therapy For Patients With Recurrent or Metastatic Gastric Cancer

Background:To determine the activity and toxicities of a low-dose leucovorin plus 5-fluorouracil (5-FU) regimen, combined with irinotecan and administered every 2 weeks (modified FOLFIRI), as a first-line therapy for patients with advanced gastric cancer. Method:Patients were treated with cycles of 150 mg/m2 irinotecan on day 1 plus 50 mg of LV, followed by a 400 mg/m2 5-FU bolus and a 22-hour continuous infusion of 600 mg/m2 5-FU on days 1 and 2. Results:The median patient age was 55 years (range, 29–75 years), and 77% (34/44) of the patients had a performance status (Eastern Cooperative Oncology Group) of 0 or 1. Of the 44 patients evaluated for their tumor response, 3 patients (6.8%) and 14 patients (31.8%) achieved a complete and partial response, respectively, with an overall response rate of 38.6% (95% confidence interval, 23.7%–53.6%). 13 patients (29.6%) evidenced a stable disease, and 14 patients (31.8%) progressed during the course of the treatment. The median time to progression and overall survival time were 4.9 months (range, 0.9–22.8 months) and 10.3 months (range, 1.2–29.0 months) from the start of the chemotherapy, respectively. A total of 293 cycles were assessed for toxicity. The major hematologic toxicities included grade 1 to 2 anemia (27.6%), neutropenia (48.8%), and grade 3 to 4 neutropenia (12.6%). There were 7 cycles of neutropenic fever. Nonhematological toxicities were observed grade 3 vomiting (6.8%), grade 3 diarrhea (4.5%), and grade 3 mucositis (2.3%). We noted no treatment-related deaths. Conclusions:The modified FOLFIRI regimen—lowering of irinotecan and LV doses—is a safe and feasible regimen as a first-line therapy for patients with recurrent or metastatic gastric cancer.