Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies
Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies
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DOI：
10.1002/ijc.33013
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发表时间：
2020-05-02
影响因子：
6.4
通讯作者：
Doi, Toshihiko
中科院分区：
文献类型：
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作者：
Piha-Paul, Sarina A.;Oh, Do-Youn;Doi, Toshihiko
我们在Keynote-158(NCT02628067；第2阶段)和Keynote-028(NCT02054806；1b阶段)研究中介绍了接受培溴利珠单抗治疗的晚期胆道癌(BTC)患者的数据。这两项研究中年龄>；=18岁的符合条件的患者都有组织学/细胞学证实的不治之症，在标准治疗方案(S)后病情恶化，实体肿瘤每反应评估标准(RECIST)1.1版，东方合作肿瘤组表现状态0/1，并且以前没有接受过免疫治疗。程序性死亡配体1(PD-L1)阳性肿瘤仅符合Keynote-028的资格。患者接受培溴利珠单抗200毫克每三周(基调-158)或每两周10毫克/公斤(基调-028)治疗
We present data from patients with advanced biliary tract cancer (BTC) receiving pembrolizumab in the KEYNOTE-158 (NCT02628067; phase 2) and KEYNOTE-028 (NCT02054806; phase 1b) studies. Eligible patients aged >= 18 years from both studies had histologically/cytologically confirmed incurable BTC that progressed after standard treatment regimen(s), measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status 0/1, and no prior immunotherapy. Programmed death ligand 1 (PD-L1)-positive tumors were required for eligibility in KEYNOTE-028 only. Patients received pembrolizumab 200 mg every three weeks (KEYNOTE-158) or 10 mg/kg every two weeks (KEYNOTE-028) for