演題抄録

一般口演

開催概要
開催回
第56回・2018年・横浜
 

胆道癌術後の大量肝切除状態におけるGEMまたはS-1療法の第I/II相試験(KHBO1003/1208)

演題番号 : O36-4

[筆頭演者]
演者)小林 省吾:1,2 
[共同演者]
永野 浩昭:1,3、波多野 悦朗:4,5、瀬尾 智:4、寺嶋 宏明:6、味木 徹夫:7、佐竹 悠良:8、亀井 敬子:9、藤山 泰二:10、廣瀬 哲朗:11、猪飼 伊和夫:12、竹村 茂一:13、柳本 泰明:14、森田 智視:15、井岡 達也:2

1:大阪大学・消化器外科、2:大阪国際がんセンター、3:山口大学・消化器・乳腺内分泌外科、4:京都大学・肝胆膵・移植外科、5:兵庫医科大学・外科、6:北野病院・消化器外科、7:神戸大学・肝胆膵外科、8:神戸市立医療センター中央市民病院・腫瘍内科、9:近畿大学・外科、10:愛媛大学・肝胆膵乳腺外科、11:日本赤十字社大津赤十字病院・外科、12:京都医療センター・外科、13:大阪市立大学・肝胆膵外科、14:関西医科大学・外科、15:京都大学・医学統計生物情報学

 

Backgrounds and aim:
Major hepatectomy may affect postoperative liver function and feasibility of adjuvant chemotherapy. We performed feasibility study of adjuvant chemotherapy (gemcitabine or s-1) after major hepatectomy due to biliary tract cancers (KHBO1003) and compared the effect of each chemotherapy (KHBO1208). These studies were performed as multicenter study and KHBO1208 study was supported by JSCO (Japan Society of Clinical Oncology) Clinical Research Grant Program 2012 and 2013; herein we show the results of these studies.
Methods:
We determined each recommended dose by the continual reassessment method in KHBO1003 phase I study and compared the feasibility and efficacy of each procedures with 10% alpha error and 20% beta error in KHBO1208 phase II study, and p values of <0.10 were considered to indicate a statistically significant difference.
Results:
KHBO1003 phase I study showed the following recommended dose: gemcitabine (1000 mg/m2) every 2 weeks or s-1 (80 mg/m2/day) for 28 days every 6 weeks. Seventy patients were enrolled in KHBO1208 phase II study and thirty-five patients were assigned to each arm. There were no statistically significant differences in the patient characteristics of the two arms. There were no statistically significant differences in the treatment completion rate and relative dose intensity of two arms. The comparison of the two arms revealed that overall survival curve of the s-1 arm were superior to gemcitabine (hazard ratio: 0.477).
Conclusion:
We completed Phase I/II study of adjuvant gemcitabine or s-1 therapy after major hepatectomy due to biliary tract cancer in multicenter study and showed the possible superiority of s-1 therapy.

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