Authors: Takuji Okusaka Akihiro Funakoshi Junji Furuse Narikazu Boku Kenji Yamao Shinichi Ohkawa Hiroshi Saito
Publish Date: 2007/05/23
Volume: 61, Issue: 4, Pages: 615-621
Abstract
This study evaluated the antitumor effect and safety of S1 an oral fluoropyrimidine derivative in patients with metastatic pancreatic cancer Chemonaive patients with pancreatic adenocarcinoma and measurable metastatic lesions were enrolled S1 was administered orally twice daily after meals at a dose of 80 100 or 120 mg/day for body surface areas BSAs of less than 125 m2 between 125 m2 and less than 15 or 15 m2 or greater respectively for 28 consecutive days followed by a 14day rest Fifteen 375 of 40 patients responded to treatment including 1 complete response and 14 partial responses The median time to progression and the overall survival time were 37 months 95 confidence interval 22–56 months and 92 months 95 confidence interval 75–108 months respectively The major adverse events were anorexia fatigue hemoglobin reduction nausea and pigmentation change although most were tolerable and reversible Although disseminated intravascular coagulation occurred in two patients the condition resolved with anticoagulant therapy S1 is an effective and welltolerated drug The effectiveness of this drug should be confirmed in a phase III studyWe thank Drs M Kurihara S Matsuno O Ishikawa and T Taguchi for their kind advice and Drs H Saisho N Moriyama and W Koizumi for the extramural review We also thank Mr M Noguchi and Dr R Azuma for their assistance in the data collection and analysis
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