2018 ASCO-GI:仑伐替尼联合PD-1抑制剂治疗晚期肝内胆管癌疗效和安全性的初步研究

2018-01-24 佚名 肿瘤资讯

肝内胆管癌(ICC)是发病率高居第二位的原发性肝脏肿瘤,尚无非常有效的治疗方法,预后较差。在刚刚结束的2018年美国临床肿瘤学会胃肠肿瘤研讨会(ASCO-GI)上,北京协和医院肝脏外科赵海涛教授团队联合至本医疗科技报告了他们的研究成果。在一项小样本临床研究中,考察了派姆单抗或纳武单抗联合仑伐替尼(Lenvatinib/E7080) 治疗晚期ICC的临床疗效和安全性,并通过二代测序技术检测了疗效相关

肝内胆管癌(ICC)是发病率高居第二位的原发性肝脏肿瘤,尚无非常有效的治疗方法,预后较差。在刚刚结束的2018年美国临床肿瘤学会胃肠肿瘤研讨会(ASCO-GI)上,北京协和医院肝脏外科赵海涛教授团队联合至本医疗科技报告了他们的研究成果。在一项小样本临床研究中,考察了派姆单抗或纳武单抗联合仑伐替尼(Lenvatinib/E7080) 治疗晚期ICC的临床疗效和安全性,并通过二代测序技术检测了疗效相关的肿瘤基因突变并计算肿瘤突变负荷(TMB)。这是首次将这一治疗策略用于晚期ICC的治疗,试验结果显示了积极的治疗效果,为后续大样本临床研究奠定了一定的基础。同时,本研究也是第一次通过TMB作为一个标志物来区分仑伐替尼联合PD-1抑制剂的临床疗效,并且也是首次揭示了中国ICC患者中TMB-H的患者人群明显高于欧美人群。

背景

仑伐替尼是一种多激酶抑制剂,最主要的作用靶点为血管内皮细胞生长因子受体(VEGFR),而派母单抗(Pembrolizumab)和纳武单抗(Nivolumab)都是FDA已经批准应用于多种晚期肿瘤的PD-1抑制剂。上述三种药物单独使用的抗肿瘤活性已得到了一定的临床试验证。但仑伐替尼联合派母单抗或纳武单抗治疗恶性肿瘤的临床疗效和安全性目前尚处于临床研究阶段。

方法

研究共纳入了14名成年晚期多线治疗的ICC患者,给予仑伐替尼10mg 每日1次口服+PD-1抑制剂(派母单抗200mg 每3周1次静脉注射,或纳武单抗140mg 每2周1次静脉注射)。在14名入组患者中,13名至少接受过两线全身系统治疗,1名患者结果过一线系统治疗。研究的主要终点包括:无进展生存期 (PFS)、客观缓解率 (ORR)、疾病控制率 (DCR),次要终点包括:临床获益率 (CBR)和安全性。在研究过程中对所有入组的患者采集肿瘤和血液样本,成功针对其中10位患者进行了450个临床可用药基因或癌症驱动基因的全面基因组测序(CGP),平均有效测序深度1000X,分析肿瘤基因组的所有变异形式并计算肿瘤突变负荷(TMB)和微卫星不稳定(MSI)状态,其余4位患者由于组织样本原因未能成功测序。


结果

研究结果显示,仑伐替尼联合 PD-1抑制剂治疗方案治疗晚期ICC患者具有一定的治疗效果。在接受治疗的14例患者中,3例患者达到PR,ORR为21.4%,DCR达到93.0%。两种PD-1抑制剂派母单抗和纳武单抗的抗肿瘤效应大致相当。疗效数据总结见下表。


对于多线治疗后的晚期ICC患者,伦伐替尼联合PD-1抑制剂治疗的中位无进展生存期为5.0个月。通过二代测序结果进一步分层分析,高的TMB值(TMB≥12)与更好的治疗反应和更长的PFS时间呈强相关性,提示TMB有可能作为判断预后的特征性标志。


安全性分析结果显示仑伐替尼联合PD-1抑制剂治疗的安全性高,受试者耐受良好,最常见的副作用为高血压,转氨酶升高以及疲劳,3例患者(21%)出现3级以上副作用。对于临床晚期肝功能较差的受试者,联合治疗方案也可耐受。

总结

目前的初步研究数据显示仑伐替尼联合PD-1抑制剂对于晚期ICC患者显示出了一定的疗效,派姆单抗和纳武单抗在与仑伐替尼的联合中均显示出抗肿瘤效应。通过基于NGS检测的标记物分析,高TMB的患者与更好的治疗响应及更长的PFS相关。联合治疗的毒副作用可控,对于晚期ICC患者可以较好耐受,本研究是PD-1抑制剂联合仑伐替尼治疗肝内胆管癌的初步研究,针对该联合方案对于晚期肝内胆管癌患者总生存期影响的临床研究仍在继续观察。


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    2018-09-19 jklm09
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    2018-10-25 quxin068
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    2018-01-29 jyzxjiangqin

    胆管癌疗效研究.

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