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

作者:Kim Byung Geun; Oh Sung Yong; Kwon Hyuk Chan; Lee Suee; Lee Dong Mee; Kim Seong Geun; Kim Do Kyong; Jang Jin Seok; Kim Min Chan; Kim Sung Hyun; Kim Hyo Jin*
来源:American Journal of Clinical Oncology: Cancer Clinical Trials , 2010, 33(3): 246-250.
DOI:10.1097/COC.0b013e3181a650d4

摘要

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/m(2) irinotecan on day 1 plus 50 mg of LV, followed by a 400 mg/m(2) 5-FU bolus and a 22-hour continuous infusion of 600 mg/m(2) 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.

  • 出版日期2010-6