演題抄録

一般演題(口演)

開催概要
開催回
第51回・2013年・京都
 

Phase III of regorafenib in pretreated advanced GIST: Japanese sub-analysis

演題番号 : O80-5

[筆頭演者]
Toshihiko Doi:1 
[共同演者]
Yoshito Komatsu:2、Akira Sawaki:3、Tatsuo Kanda:4、Yasuhide Yamada:5、Christian Kappeler:6、Iris Kuss:6、George D Demetri:7、Toshirou Nishida:8

1:National Cancer Center Hospital East, Japan、2:Hokkaido University Hospital, Japan、3:Japan Red Cross Nagoya Daini Hospital, Japan、4:Niigata University, Japan、5:National Cancer Center Hospital, Japan、6:Bayer HealthCare, Japan、7:Dana-Farber Cancer Institute and Harvard Medical School, Japan、8:Osaka Police Hospital, Japan

 

The GRID trial is the international Phase III of regorafenib (REG) compared to placebo (PL) in patients (pts) with metastatic gastrointestinal tumor (GIST) following failure of at least imatinib (IM) and sunitinib (SU). The trial met primary endpoint which showed statistically significant longer progression free survival (PFS) in REG compared with PL. We report here the efficacy and safety of REG in Japanese sub-population (J-population).Pts with metastatic and/or unresectable GIST, objective failure of both prior IM and SU were randomized 2:1 to receive best supportive care (BSC) with either REG 160 mg po once daily (3 weeks on/1 week off) or PL. The primary endpoint was PFS by central assessment. Secondary endpoints included overall survival, tumor response and safety. Seventeen Japanese metastatic GIST pts were enrolled in this trial (REG: 12, PL: 5). Demographics were generally consistent with the overall study population. PFS in the J-population was significantly longer in REG arm compared with PL arm (HR 0.08, 95% CI, 0.02-0.45; 1-sided p=0.000164), as well as overall population (HR 0.27, 95% CI, 0.19-0.39; 1-sided p<0.000001). The J- and overall population showed similar disease control rate (REG 59%, PL 20 %, p=0.081; REG 56 %, PL 9%, p<0.000001, respectively). In J-population, commonly observed drug-related adverse events (AEs) in REG arm were hand-foot skin reaction (HFSR) 92%, mucositis oral 58%, hypertension, hoarseness, alopecia, rash maculo-papular, proteinuria and diarrhea 50%. There was no unexpected AE in J-population. The subset analysis of Japanese showed higher incidence of AEs compared with non J-population. The incidence of drug related discontinuation did not show any differences (J: 8%, Non-J: 6%). AEs were manageable by dose modification. In conclusion, the subset analysis of the J-population was considered similar efficacy and acceptable AE profile as well as the results of GRID trial, even in limited number of J-population.

キーワード

臓器別:その他

手法別:分子標的治療

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