Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer
Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer
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DOI：
10.1136/jitc-2020-000587
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发表时间：
2020-01-01
影响因子：
10.9
通讯作者：
Maitra, Anirban
中科院分区：
文献类型：
--
作者：
Overman, Michael;Javle, Milind;Maitra, Anirban
背景胰腺癌的免疫抑制性促结缔组织增生间质是产生有效免疫应答的主要障碍。胰腺癌的临床前研究已经证明了有前途的抗肿瘤活性与布鲁顿酪氨酸激酶（BTK）抑制结合程序性细胞死亡受体-1（PD-1）blocking.Methods这是一个II期，多中心，开放标签，随机（1：1）临床试验评估BTK抑制剂acalabrutinib，单独（单药治疗）或与抗PD-1抗体pembrolizumab（联合治疗）。合格患者为经组织学证实的转移性或局部晚期不可切除的胰腺导管腺癌且具有美国东部肿瘤协作组体能状态（ECOG PS）的成人患者
Background The immunosuppressive desmoplastic stroma of pancreatic cancer represents a major hurdle to developing an effective immune response. Preclinical studies in pancreatic cancer have demonstrated promising anti-tumor activity with Bruton tyrosine kinase (BTK) inhibition combined with programmed cell death receptor-1 (PD-1) blockade.Methods This was a phase II, multicenter, open-label, randomized (1:1) clinical trial evaluating the BTK inhibitor acalabrutinib, alone (monotherapy) or in combination with the anti-PD-1 antibody pembrolizumab (combination therapy). Eligible patients were adults with histologically confirmed metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma with an Eastern Cooperative Oncology Group Performance Status (ECOG PS)