SWOG S1310: Randomized phase II trial of single agent MEK inhibitor trametinib vs. 5-fluorouracil or capecitabine in refractory advanced biliary cancer.
SWOG S1310: Randomized phase II trial of single agent MEK inhibitor trametinib vs. 5-fluorouracil or capecitabine in refractory advanced biliary cancer.
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SWOG S1310：单药 MEK 抑制剂曲美替尼与 5-氟尿嘧啶或卡培他滨治疗难治性晚期胆道癌的随机 II 期试验。
DOI：
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发表时间：
2015
期刊：
影响因子：
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通讯作者：
H. Hochster
中科院分区：
文献类型：
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作者：
R. Kim;Shannon L. McDonough;A. El;T. Bekaii;S. Stein;V. Sahai;G. Keogh;Edward J. Kim;A. Baron;A. Siegel;A. Barzi;K. Guthrie;M. Javle;H. Hochster
4016背景：对于吉西他滨/铂类药物治疗失败的晚期BC患者，没有标准的治疗选择。曲美替尼评价的依据是基于MAPK改变的存在和其他MEK抑制剂在BC中的早期有希望的结果。研究方法：吉西他滨/铂类药物治疗进展的组织学证实BC患者随机分配至曲美替尼（2 mg qd）（A组）vs输注5 FU 2400 mg/m2 46小时或卡培他滨（1000 mg/m2 PO第1-14天BID）（B组）。按计划化疗5 FU/LV vs卡培他滨和疾病部位：胆管癌vs胆囊对患者进行分层。主要终点为总生存期（OS）。次要终点包括无进展生存期（PFS）和缓解率（RR）。需要80例合格患者（每组40例）检测中位OS从5个月改善至8.25个月（1.65 HR）。对注册到曲美替尼的前14例患者进行了计划的客观缓解中期无效分析。
4016Background: No standard treatment options are available for patients with advanced BC who fail gemcitabine/platinum therapy. The rationale for evaluation of trametinib was based on the presence of MAPK alterations and on earlier promising results with other MEK inhibitors in BC. Methods: Pts with histologically proven BC who progressed on gemcitabine/platinum were randomized to trametinib (2mg qd) (Arm A) vs infusional 5FU at 2400 mg/m2 over 46 hours or capecitabine (1000 mg/m2PO days 1-14 BID) (Arm B). Patients were stratified by planned chemotherapy 5FU/LV vs capecitabine; and disease site: cholangiocarcinoma vs gallbladder. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS) and response rate (RR). 80 eligible patients (40 for each arm) were needed to detect an improvement in median OS from 5 months to 8.25 months (1.65 HR). A planned interim futility analysis of objective response was performed on the first 14 pts registered to the trametini...