PURPOSE: A 3 week treatment schedule consisting of 2 weeks of S-1 therapy and 1 week of no therapy was introduced to reduce the toxicity and increase the convenience of combination chemotherapy. Hepatic dysfunction (HD) is common in patients with biliary tract cancer. A phase I study was conducted to assess the effects of a 3 week treatment schedule in Asian patients with or without HD. METHODS: Forty-six patients were stratified into four groups, according to the HD criteria of the National Cancer Institute Organ Dysfunction Working Group. A three dose escalation schema was used. RESULTS: In the normal hepatic function group, two dose-limiting toxicity (DLT) events occurred among 12 patients at the prespecified maximal dose of 100 mg/m²/day. This dose was thereby established as the maximal tolerable dose (MTD). No DLT events were observed at the predefined maximal dose of 80 mg/m²/day in the mild HD group. In the moderate HD group, two DLT events occurred among five patients treated with 80 mg/m²/day, and the MTD was defined as 70 mg/m²/day. Two of six subjects in the severe HD group experienced DLT events at doses of 60 mg/m²/day and none developed DLT events at 50 mg/m²/day. CONCLUSIONS: The MTDs for a 3 week schedule of S-1 treatment were defined in patients with or without hepatic dysfunction. A 3 week treatment regimen of S-1 might be a platform for combination with newer cytotoxic agents or biologics.
PURPOSE: A 3 week treatment schedule consisting of 2 weeks of S-1 therapy and 1 week of no therapy was introduced to reduce the toxicity and increase the convenience of combination chemotherapy. Hepatic dysfunction (HD) is common in patients with biliary tract cancer. A phase I study was conducted to assess the effects of a 3 week treatment schedule in Asian patients with or without HD. METHODS: Forty-six patients were stratified into four groups, according to the HD criteria of the National Cancer Institute Organ Dysfunction Working Group. A three dose escalation schema was used. RESULTS: In the normal hepatic function group, two dose-limiting toxicity (DLT) events occurred among 12 patients at the prespecified maximal dose of 100 mg/m²/day. This dose was thereby established as the maximal tolerable dose (MTD). No DLT events were observed at the predefined maximal dose of 80 mg/m²/day in the mild HD group. In the moderate HD group, two DLT events occurred among five patients treated with 80 mg/m²/day, and the MTD was defined as 70 mg/m²/day. Two of six subjects in the severe HD group experienced DLT events at doses of 60 mg/m²/day and none developed DLT events at 50 mg/m²/day. CONCLUSIONS: The MTDs for a 3 week schedule of S-1 treatment were defined in patients with or without hepatic dysfunction. A 3 week treatment regimen of S-1 might be a platform for combination with newer cytotoxic agents or biologics.
Authors: K Ikeda; K Yoshisue; E Matsushima; S Nagayama; K Kobayashi; C A Tyson; K Chiba; Y Kawaguchi Journal: Clin Cancer Res Date: 2000-11 Impact factor: 12.531
Authors: Andrew X Zhu; Jeffrey W Clark; David P Ryan; Jeffrey A Meyerhardt; Peter C Enzinger; Craig C Earle; Charles S Fuchs; Eileen Regan; Hiroshi Anbe; Michele Houghton; Joshua Zhang; Peter Urrea; Matthew H Kulke Journal: Cancer Chemother Pharmacol Date: 2006-06-20 Impact factor: 3.333
Authors: T Taguchi; Y Inuyama; R Kanamaru; K Hasegawa; S Akazawa; H Niitani; H Furue; M Kurihara; K Ota; S Suga; Y Ariyoshi; S Takai; T Shimoyama; T Toge; S Takashima; K Sugimachi; Y Hara; H Fujita; K Kimura; T Saito; S Tsukagoshi; I Nakao Journal: Gan To Kagaku Ryoho Date: 1997-12
Authors: A Nakeeb; H A Pitt; T A Sohn; J Coleman; R A Abrams; S Piantadosi; R H Hruban; K D Lillemoe; C J Yeo; J L Cameron Journal: Ann Surg Date: 1996-10 Impact factor: 12.969
Authors: M Ducreux; P Rougier; A Fandi; M C Clavero-Fabri; A L Villing; F Fassone; L Fandi; J Zarba; J P Armand Journal: Ann Oncol Date: 1998-06 Impact factor: 32.976