演題抄録

一般口演

開催概要
開催回
第55回・2017年・横浜
 

大腸癌レゴラフェニブ療法に対する経口ステロイドの検討(KSCC1402/HGCSG1402)

演題番号 : O31-3

[筆頭演者]
白石 猛:1 
[共同演者]
佐竹 悠良:2、宮本 裕士:3、谷岡 洋亮:4、辻 晃仁:5、朝山 雅子:6、結城 敏志:7、小髙 雅人:8、牧山 明資:9、小松 嘉人:10、佐伯 浩司:11、沖 英次:11、江見 泰徳:11,12、馬場 秀夫:3、前原 喜彦:11

1:日本赤十字社松山赤十字病院・臨床腫瘍科、2:地方独立行政法人神戸市民病院機構神戸市立医療センター中央市民病院・腫瘍内科、3:熊本大学・大学院・消化器外科学、4:独立行政法人労働者健康安全機構岡山労災病院・腫瘍内科、5:香川大学・医学部・臨床腫瘍学、6:埼玉県立がんセンター・消化器内科、7:北海道大学・大学院医学研究科・消化器内科、8:医療法人薫風会佐野病院・消化器がんセンター、9:独立行政法人・地域医療機能推進機構九州病院・血液・腫瘍内科、10:北海道大学・病院・腫瘍センター、11:九州大学・大学院医学研究院・消化器・総合外科、12:社会福祉法人恩賜財団済生会支部福岡県済生会福岡総合病院・外科

 

Background: Regorafenib (REG) has survival benefit in salvage line therapy for metastatic colorectal cancer(mCRC); fatigue and malaise are common AEs cause REG treatment discontinuation. KSCC1402/HGCSG1402 investigated the prophylactic effect of oral dexamethasone (DEX) for regorafenib-related fatigue and/or malaise which is a major regorafenib-related adverse event. We report influence of oral dexamethasone (DEX) for regorafenib on overall survival (OS) and progression free survival (PFS).
Patients and Methods: Patients with mCRC who progressed after standard chemotherapy were randomized 1:1 to an oral DEX (2 mg/day, days 1-28) with regorafenib (160 mg/day, days 1-21) or a placebo with regorafenib group. The primary endpoint was the incidence of fatigue and/or malaise, based on version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) assessed by the investigators during the protocol period.
Results: Seventy-four pts were enrolled and randomized (dex: 37, PLC: 37). Baseline characteristics were balanced between the two arms. Patients who had grade 1 fatigue at baseline were included 50.0 % and 58.3% in dex and PLC arm respectively. After treatment, the incidence of all grade of malaise and/or fatigue based on CTCAE for dex arm was 58.3% and 61.1% for PLC arm (p=0.8101), that based on PRO CTCAE was 47.2% vs. 58.3% (p=0.3450). The incidence of grade 2 of malaise and/or fatigue based on CTCAE was 19.4% vs. 38.9% (p=0.0695), that based on PRO was 27.8% vs. 52.8% (p=0.0306). However, there was no difference between the two groups in median OS (8.1 months vs. 8.7months;p=0.3680) and in median PFS (2.4months vs. 2.3 months;p=0.5782).
Conclusion: The KSCC1402/HGCSG1402 study provided promising results that improve the supportive therapy for pts with REG-related fatigue and malaise. The prophylactic steroid did not have positive or negative impact on the OS and PFS.

キーワード

臓器別:大腸・小腸

手法別:化学療法

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