演題抄録

ポスター

開催概要
開催回
第58回・2020年・京都
 

IRIS/Bev療法時の下痢に対する半夏瀉心湯予防投与の第二相試験:生存期間の解析

演題番号 : P-122

[筆頭演者]
原田 一顕:1 
[共同演者]
中積 宏之:2、川本 泰之:3、結城 敏志:1、石黒 敦:4、舘山 美樹:5、宮城島 拓人:6、中村 路夫:7、太宰 昌佳:8、奥田 博介:9、畑中 一映:10、天野 虎次:11、小松 嘉人:3

1:北海道大学病院・消化器内科、2:北海道医療センター・消化器内科、3:北海道大学病院・腫瘍センター、4:手稲渓仁会病院・腫瘍内科、5:苫小牧日翔病院・内科、6:釧路労災病院・内科、7:市立札幌病院・消化器内科、8:NTT東日本札幌病院・消化器内科、9:札幌病院・腫瘍内科、10:市立函館病院・消化器内科、11:北海道大学病院・臨床研究開発センター

 

Background: IRIS (irinotecan plus S-1) plus bevacizumab (IRIS/Bev) is one of the standard chemotherapies for metastatic colorectal cancer (mCRC) as the first-line or second-line therapy. The most frequent non-hematological adverse event of IRIS is diarrhea. Hange-shashin-to (HST) is a Kampo medicine which is used in Japan for the treatment of gastritis, stomatitis, and diarrhea. We conducted this study to evaluate the usefulness of HST to prevent diarrhea in patients with mCRC receiving IRIS/Bev as the second-line therapy.
Methods: This trial was designed as a multicenter, randomized, double-blind, placebo-controlled study. We administrated HST 2.5g or placebo PO t.i.d. for 3 months from the first administration of IRIS/Bev. The primary endpoint was proportion of ≥grade 3 diarrhea assessed by CTCAE v4.0. This study was registered with UMIN-CTR, number UMIN000012276.
Results: Between Jan 1, 2014 and Mar 31, 2017, 59 patients from 11 institutes in Japan were randomly assigned to receive HST (n=28, Group H) or placebo (n=27, Group P). The proportions of ≥grade 3 diarrhea was 10.7% in Group H and 22.2% in Group P (p=0.296). The other major adverse events of ≥grade 3 in Group H vs Group P were fatigue (7.1% vs 14.8%), anorexia (14.3% vs 14.8%), and nausea (0.0% vs 3.7%). The overall response rate was 27.2% in Group H vs 23.1% in Group P (p=0.751). There were not statistically significant differences in median progression-free survival (mPFS), median time to treatment failure (mTTF), and median overall survival (mOS) between Group H and Group P ( mPFS 7.9 vs 5.9 months; p=0.368; mTTF 3.9 vs 5.6; p=0.831; mOS 17.0 vs 15.3 months; p=0.401).
Conclusion: There was no statistically significant difference in diarrhea between the groups. The update analysis of anti-tumor efficacy showed that IRIS/Bev had promising survival benefit but there is not statistically significant difference between HST and placebo.

キーワード

臓器別:大腸・小腸

手法別:臨床試験

前へ戻る