PDF(Pubmed)
Abstract：
Durvalumab (Imfinzi®), a therapeutic human monoclonal antibody which binds to and blocks the activity of the immunosuppressive programmed death-ligand 1 (PD-L1) protein, is approved in the USA, EU, Japan and other countries in combination with gemcitabine and cisplatin for adults with advanced biliary tract cancer. In the pivotal phase 3 TOPAZ-1 trial, durvalumab plus gemcitabine and cisplatin significantly prolonged overall survival and progression-free survival compared with placebo plus gemcitabine and cisplatin in adults with advanced biliary tract cancer. Benefit from durvalumab was seen irrespective of primary tumour location, disease status at diagnosis (unresectable or recurrent), or initial levels of PD-L1 expression. The tolerability of durvalumab plus gemcitabine and cisplatin was manageable. Overall, the addition of durvalumab to gemcitabine and cisplatin is a valuable new treatment option for adults with advanced biliary tract cancer.
Biliary tract cancers are a diverse group of cancers that develop in the bile ducts or the gallbladder. Patients with these cancers typically have poor survival. Chemotherapy (gemcitabine plus cisplatin) has been the first-line treatment for biliary tract cancer for over a decade, with no new treatments further improving on its overall survival benefit until recently. Durvalumab (Imfinzi®) belongs to a class of drugs known as checkpoint inhibitors; these drugs activate the immune system to help fight cancer. In the phase 3 TOPAZ-1 trial, the addition of durvalumab to first-line chemotherapy prolonged the overall survival compared with placebo plus chemotherapy in adults with advanced biliary tract cancer. The tolerability of durvalumab in combination with chemotherapy was manageable. Thus, durvalumab plus gemcitabine and cisplatin is a valuable new treatment option for adults with advanced biliary tract cancer.
Biliary tract cancers are a diverse group of cancers that develop in the bile ducts or the gallbladder. Patients with these cancers typically have poor survival. Chemotherapy (gemcitabine plus cisplatin) has been the first-line treatment for biliary tract cancer for over a decade, with no new treatments further improving on its overall survival benefit until recently. Durvalumab (Imfinzi®) belongs to a class of drugs known as checkpoint inhibitors; these drugs activate the immune system to help fight cancer. In the phase 3 TOPAZ-1 trial, the addition of durvalumab to first-line chemotherapy prolonged the overall survival compared with placebo plus chemotherapy in adults with advanced biliary tract cancer. The tolerability of durvalumab in combination with chemotherapy was manageable. Thus, durvalumab plus gemcitabine and cisplatin is a valuable new treatment option for adults with advanced biliary tract cancer.
摘要：
Durvalumab（Imfinzi®），一种治疗性人单克隆抗体，与免疫抑制性程序性死亡配体1（PD-L1）蛋白结合并阻断其活性，在美国被批准，欧盟,日本等国度联合吉西他滨和顺铂医治成人晚期胆道癌。在关键阶段3TOPAZ-1试验中，与安慰剂联合吉西他滨和顺铂相比,durvalumab联合吉西他滨和顺铂可显著延长晚期胆道癌患者的总生存期和无进展生存期.Durvalumab的获益与原发肿瘤位置无关，诊断时的疾病状态（不可切除或复发），或PD-L1表达的初始水平。durvalumab联合吉西他滨和顺铂的耐受性是可控的。总的来说,在吉西他滨和顺铂的基础上加用durvalumab是治疗成人晚期胆道癌的一种有价值的新治疗选择.
胆道癌是在胆管或胆囊中发展的一组不同的癌症。患有这些癌症的患者通常具有较差的存活率。化疗（吉西他滨加顺铂）十多年来一直是胆道癌的一线治疗方法，直到最近，没有新的治疗方法进一步改善其总体生存获益。Durvalumab（Imfinzi®）属于一类称为检查点抑制剂的药物;这些药物激活免疫系统以帮助对抗癌症。在第3阶段TOPAZ-1试验中,在晚期胆道癌患者中,与安慰剂+化疗相比,在一线化疗中加入durvalumab可延长患者的总生存期.durvalumab联合化疗的耐受性是可控的。因此，durvalumab联合吉西他滨和顺铂是治疗成人晚期胆道癌的有价值的新选择.
胆道癌是在胆管或胆囊中发展的一组不同的癌症。患有这些癌症的患者通常具有较差的存活率。化疗（吉西他滨加顺铂）十多年来一直是胆道癌的一线治疗方法，直到最近，没有新的治疗方法进一步改善其总体生存获益。Durvalumab（Imfinzi®）属于一类称为检查点抑制剂的药物;这些药物激活免疫系统以帮助对抗癌症。在第3阶段TOPAZ-1试验中,在晚期胆道癌患者中,与安慰剂+化疗相比,在一线化疗中加入durvalumab可延长患者的总生存期.durvalumab联合化疗的耐受性是可控的。因此，durvalumab联合吉西他滨和顺铂是治疗成人晚期胆道癌的有价值的新选择.
