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

• DOI: 10.1097/coc.0b013e3181a650d4
• Publication Date: 2010-03-27T09:24:09Z
• Authors: Byung Geun Kim; Sung Yong Oh; Hyuk-Chan Kwon; Suee Lee; Dong Mee Lee; Seong-Geun Kim; Do-Kyong Kim; Jin Seok Jang; Min Chan Kim; Sung-Hyun Kim; Hyo-Jin Kim
• Keywords: FOLFIRI; Bolus (digestion); Continuous Infusion

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