Title: Phase II trial with S-1 in chemotherapy-naive patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)
Authors: Chollet, P ×
Schöffski, Patrick
Weigang-Kohler, K
Schellens, JHM
Cure, H
Pavlidis, N
Grunwald, V
De Boer, R
Wanders, J
Fumoleau, P #
Issue Date: Jun-2003
Publisher: Pergamon-elsevier science ltd
Series Title: European journal of cancer vol:39 issue:9 pages:1264-1270
Abstract: S-1 is a new oral fluorinated pyrimidine derivate, in which the oral 5-fluorouracil (5-FU) prodrug, tegafur, was combined with two 5-FU-modulating substances, 5-chloro-2,4-dihydroxypyridine (gimeracil), and potassium oxonate (oteracil), at a molar ratio of 1:0.4:1. The final mechanism of action is exerted by 5-FU. The present study is the first European phase 11 trial of S-I in gastric cancer. The primary study objectives were the safety, toxicity and activity of S-I in non-pretreated patients with gastric cancer. The secondary objective was the duration of response. Patients had to have histologically- or cytologically-verified metastatic or locally advanced, unresectable gastric cancer; S-I was administered orally twice daily at 40, then 35 mg/m(2) for 28 days every 5 weeks. The starting dose of,40 mg/m(2) was found to be intolerable due to significant non-haematological toxicity, and this dose was rapidly reduced to 35 mg/m(2) twice daily. Of the 7 patients enrolled at the 40 mg/m(2) level, only 3 were evaluable. At 35 mg/m(2), a response rate of 26.1% (95% Confidence Interval (CI) 12.0-45.1%) in 23 enrolled patients, and 31.6% (C.I. 14.7-53.0%) in 19 evaluable patients according to an independent radiology review, was found. The median duration of response at 35 mg/m(2) (6 patients) was 223 days (range, 108-828 days), and of stable disease was I I I days (range 68-411 days). S-I can be administered with an acceptable safety and toxicity in European patients at a dose of 35 mg/m(2) days 1-28 every 5 weeks and is associated with a moderate response rate similar to the results achieved with other fluoropyrimidines. (C) 2003 Elsevier Science Ltd. All rights reserved.
ISSN: 0959-8049
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Experimental Oncology
× corresponding author
# (joint) last author

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