Phase II study of irinotecan plus leucovorin and bolus 5 fluorouracil as first or second line chemotherapy in patients with advanced gastric or esophageal-gastric junction adenocarcinoma

Abstract

15128 Background: The aim of this study was to evaluate the activity and safety of 5-fluorouracil (5-FU) / leucovorin (LV) and irinotecan as first- or second-line treatment in patients with advanced gastric adenocarcinoma. Methods: Treatment consisted of irinotecan 80 mg/m2 intravenously (i.v.), followed by LV 200 mg/m2 (i.v.) and 5- FU 450 mg/m2 as an i.v. bolus. Treatment was administered weekly for 6 weeks, followed by a 2-week rest period. Results: Thirty-one patients (23 chemo-naïve, 8 chemo-exposed) were enrolled. The overall response rate was 22.6% and the disease control rate was 38.7%. Among the patients who received the regimen as first-line treatment, objective response rate was 30.4% and the disease control rate was 52.1%. However, progression of the disease was recorded in all the patients receiving the combination as second-line chemotherapy. The median time to disease progression (TTP) was 4 months and the median duration of survival was 7 months. The median TTP was 6 months for patients treated with first-line chemotherapy and 2.5 for those who received study treatment as second line. Furthermore, the median survival duration was 8 months and 6 months, respectively. The most frequent grade 4 toxicity was febrile neutropenia. Grade 3 or 4 non-hematological toxicities were rare. There were no treatment-related deaths. Conclusions: The combination of 5-FU/LV and irinotecan as first-line treatment was found to be well tolerated, with efficacy comparable to that of other regimens in advanced gastric cancer. Accordingly, this regimen can be regarded as one of first-line options, particularly in patients who can not tolerate aggressive chemotherapy. No significant financial relationships to disclose.