演題抄録

臓器別シンポジウム

開催概要
開催回
第51回・2013年・京都
 

Tolerability Study of Adjuvant FOLFOX in Stage II/III Colon Cancer (JOIN Trial)

演題番号 : OS3-7

[筆頭演者]
當山 鉄男:1 
[共同演者]
小高 雅人:2、篠崎 勝則:3、間中 大:4、松井 隆則:5、石榑 清:6、大庭 幸治:7、坂本 純一:8、佐治 重豊:8、大津 敦:9、渡邉 聡明:10、吉野 孝之:9

1:中頭病院 外科、2:佐野病院、3:県立広島病院、4:京都桂病院、5:愛知県がんセンター愛知病院、6:江南厚生病院、7:北海道大学病院、8:がん集学的治療研究財団、9:国立がん研究センター東病院、10:東京大学

 

Background:Adjuvant FOLFOX is a widely accepted standard regimen for resected colon cancer.The incidence of grade ≧3 peripheral sensory neuropathy (PSN) was 12.4% and 5.7% in Western MOSAIC and Eastern MASCOT (outside Japan) trials, while that of grade ≧3 allergic reactions (AR) was 2.9% and 3.1%, respectively. JFMC41-1001-C2 Trial, so-called「JOIN Trial」investigated the tolerability of mFOLFOX6 in Japanese patients(UMIN ID: 000004443)Methods:Twelve cycles of mFOLFOX6 were given to patients fitting the following criteria, which were the same as those of MOSAIC: stage II/III curatively resected colon cancer, performance status (PS) of 0~1, 20 years or older, starting FOLFOX within 7 weeks of surgery, and adequate organ function. The primary endpoint was the incidence of PSN persisting for at least 8 days that interfered with daily activities and that of grade ≧3 AR. Target sample size was 800, assuming the expected incidence of grade≧3 PSN and grade ≧3 AR would be 12.0% and 3.0%, and the two-sided 95% confidence interval (CI) would not include the corresponding threshold levels (16.5% for PSN and 6.5% for AR) with a 95% probability. Results:From November 2010 to March 2012, 882 patients were enrolled at 198 institutions.The safety analysis included 848 patients receiving mFOLFOX6, and 828 patients whose data were finalized were presented. Patient characteristics included: median age of 64 years (21~83); Male/ Female: 444/384; PS 0/1: 776/52; colon/rectosigmoid: 633/195; and stage II/IIIa/IIIb: 152/402/274. The incidence of persistent PSN was 3.3% (95% CI: 2.2%~4.7%), while that of grade≧3 AR was 1.7% (95% CI: 0.9%~2.8%), and the primary endpoint was met. Only grade≧3 neutropenia had a ≧10% incidence (28.7%). The incidence of grade≧3 PSN was 5.8%, and interstitial pneumonitis was observed in one case. There was no treatment-related death. The completion treatment rate was 67%. Conclusions:Adjuvant mFOLFOX6 is tolerable in Japanese colon cancer patients.

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