伊马替尼对照干扰素辅助治疗c-Kit突变的黑色素瘤患者的Ⅱ期临床研究.pdf

202 ()2017 1 11 2 Chin J Clinicians(Electronic Edition),January 15,2017,Vol.11,No.2 c-Kit 毛丽丽 王轩 孔燕 代杰 白雪 迟志宏 崔传亮 盛锡楠 连斌 鄢谢桥 唐碧霞 李思明 郭军 斯璐 c-Kit NCDIc-Kit 48c-Kit 91113 6 2 12400 mg/dHDI1510 U/m d1 d5/4 9106 U348 RFS DMFSOS c-Kit c-KitL576P 13DIRFS29.895% CI 23.336.3 10.095% CI 020.0P=0.029c-KitL576P P=0.0054.8HDI34.2OSP=0.43 HDI34 HDIc-Kit RFSc-Kit  α c-Kit Phase randomized trial comparing imatinib with high-dose interferon alpfa-2b as adjuvant therapy for high-risk melanoma patients with c-Kit mutations Mao Lili, Wang Xuan, Kong Yan, Dai Jie, Bai Xue, Chi Zhihong, Cui Chuanliang, Sheng Xinan, Lian Bin, Yan Xieqiao, Tang Bixia, Li Siming, Guo Jun, Si Lu. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital Institute, Beijing 100142, China Corresponding author: Si Lu, Email: silu15_silu@126.com Abstract Objective Imatinib has changed the treatment paradigm for metastatic melanoma with c-Kit aberrations. However, it has not been trailed whether imatinib could be used as adjuvant therapy for melanomas. We conducted a randomized phase clinical trial (NC in high-risk melanoma patients bearing c-Kit mutations to compare the efficacy and safety of imatinib with high-dose IFN-α2b (HDI). Methods Forty-eight high-risk melanoma patients (stage b-c) with c-Kit mutations in exons 9, 11 or 13 after surgery without prior systemic therapy were randomized (ratio of 12) to 6 2 6 imatinib (400 mg daily) or HDI (15×10 Unit/m d1-5/week×4 weeks