臨牀消化器内科 Vol.16 No.5(1)


特集名 消化器悪性腫瘍に対する化学療法
題名 化学療法の効果判定
発刊年月 2001年 05月
著者 宮田 佳典 佐久総合病院内科・胃腸科
【 要旨 】 化学療法の効果と安全性評価の規準が最近改訂された.Response Evaluation Criteria in Solid Tumors (RECIST) とNational Cancer lnstitute-Common Toxicity Criteria, version2(NCI-CTC, v2)である.これらの規準は正確性,再現性で旧版に優っている.しかし,消化器癌では原発巣のみの症例の評価が不可能となる点が問題と思われる.最近,薬剤の症状緩和効果を評価するためにclinical benefit responseという考えが提唱され膵癌の臨床試験では実際に用いられている.また,time to progressionも重要な効果判定方法であるが統一した規準がない.NCI-CTC, v2は急性放射線障害には使用可能だが,晩期放射線障害にはRTOG/EORTCのスキームを用いる.
Theme Chemotherapy for Gastrointestinal Malignancy
Title Response and Toxicity Evaluation Following Chemotherapy for Gastrointestinal Cancer
Author Yoshinori Miyata Department of Gastroenterology/Internal Medicine, Saku Central Hospital
[ Summary ] Response and toxicity evaluation guidelines commonly employed in clinical trials have recently been revised. These include the Response Evaluation Criteria in Solid Tumors (RECIST) and National Cancer Institute-Common Toxicity Criteria, version 2 (NCI-CTC, v2). These guidelines are not only more accurate and reproducible than the former versions, but more convenient to work with. There is a controversy over the methods used to evaluate primary gastrointestinal cancers in the Japanese criteria, which are the standard evaluation guidelines for trials conducted in Japan, and have not been validated. Some other measures have been introduced to evaluate the efficacy of anticancer agents. For example, the clinical benefit response has already been utilized in pancreatic cancer trials. Time to progression has also been recognized as an important measure to evaluate the efficacy of cytostatic agents, but a standardized definition has not been elucidated.
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