Abstract：
UNASSIGNED: Researchers wanted to study whether the research drug zanidatamab could help people with a type of cancer called biliary tract cancer. In some people, biliary tract cancer cells make extra copies of a gene called HER2 (also called ERBB2). This is known as being HER2-amplified. Zanidatamab is an antibody designed to destroy cancer cells that have higher-than-normal HER2 protein or gene levels. Zanidatamab is currently under research and is not yet approved for any diseases. Participants in this phase 2b clinical study had tumors that were HER2-amplified and at the advanced or metastatic stage. Participants also had cancer which had become worse after previous chemotherapy or had side effects that were too bad to continue chemotherapy. They also had to meet other requirements to be enrolled. Researchers measured the amount of HER2 protein in the tumor samples of the participants who were enrolled. There were 80 participants with tumors that were both HER2 amplified and had higher-than-normal HER2 protein amounts (considered to be \'HER2-positive\'). There were 7 participants with tumors that were HER2-amplified, but had little-to-no levels of the HER2 protein (considered to be \'HER2-low\'). All participants in the study were treated with zanidatamab and no other cancer treatments once every 2 weeks.
UNASSIGNED: In the HER2-positive group, 33 of 80 (41%) participants had their tumors shrink by 30% or more of their original size. In half of these participants, their tumors did not grow for 13 months or longer. No participant in the HER2-low group had their tumors shrink by 30% or more. In total, 63 of 87 participants (72%) had at least one side effect believed to be related to zanidatamab treatment. Most side effects were mild or moderate in severity. No participant died from complications related to zanidatamab. Diarrhea was one of the more common side effects and was experienced by 32 of 87 participants (37%). Side effects related to receiving zanidatamab through the vein, such as chills, fever, or high blood pressure, were experienced by 29 of 87 participants (33%).
UNASSIGNED: The results of this study support the potential for zanidatamab as a new therapy for people with HER2-positive biliary tract cancer after they had already received chemotherapy. More research is occurring to support these results.Clinical Trial Registration: NCT04466891 (HERIZON-BTC-01 study).
The HERIZON-BTC-01 study revealed zanidatamab as a potentially effective treatment for HER2-positive biliary tract cancer after standard chemotherapy fails. Read more in the lay summary by @hardingjjmd, @DrShubhamPant, and coauthors. #BiliaryTractCancer #HER2 #zanidatamab.
UNASSIGNED: In the HER2-positive group, 33 of 80 (41%) participants had their tumors shrink by 30% or more of their original size. In half of these participants, their tumors did not grow for 13 months or longer. No participant in the HER2-low group had their tumors shrink by 30% or more. In total, 63 of 87 participants (72%) had at least one side effect believed to be related to zanidatamab treatment. Most side effects were mild or moderate in severity. No participant died from complications related to zanidatamab. Diarrhea was one of the more common side effects and was experienced by 32 of 87 participants (37%). Side effects related to receiving zanidatamab through the vein, such as chills, fever, or high blood pressure, were experienced by 29 of 87 participants (33%).
UNASSIGNED: The results of this study support the potential for zanidatamab as a new therapy for people with HER2-positive biliary tract cancer after they had already received chemotherapy. More research is occurring to support these results.Clinical Trial Registration: NCT04466891 (HERIZON-BTC-01 study).
The HERIZON-BTC-01 study revealed zanidatamab as a potentially effective treatment for HER2-positive biliary tract cancer after standard chemotherapy fails. Read more in the lay summary by @hardingjjmd, @DrShubhamPant, and coauthors. #BiliaryTractCancer #HER2 #zanidatamab.
摘要：
■研究人员想研究研究药物zanidatamab是否可以帮助患有一种称为胆道癌的癌症的人。在一些人中,胆道癌细胞产生一个称为HER2（也称为ERBB2）的基因的额外拷贝。这被称为HER2扩增。Zanidatamab是一种旨在破坏具有高于正常HER2蛋白或基因水平的癌细胞的抗体。Zanidatamab目前正在研究中，尚未批准用于任何疾病。这项2b期临床研究的参与者患有HER2扩增的肿瘤，处于晚期或转移阶段。参与者还患有癌症，这种癌症在先前的化疗后变得更糟，或者副作用太糟糕而无法继续化疗。他们还必须满足其他要求才能注册。研究人员测量了参与者肿瘤样本中HER2蛋白的含量。有80名参与者的肿瘤既被HER2扩增，又具有高于正常的HER2蛋白量（被认为是“HER2阳性”）。有7名参与者患有HER2扩增的肿瘤，但几乎没有HER2蛋白水平（被认为是“HER2低”）。研究中的所有参与者每2周接受一次zanidatamab治疗，没有其他癌症治疗。
■在HER2阳性组中，80名参与者中有33名（41％）的肿瘤缩小了原始大小的30％或更多。在这些参与者中，有一半他们的肿瘤在13个月或更长时间内没有生长。低HER2组没有参与者的肿瘤缩小30%或更多。总的来说,87名参与者中有63名（72％）至少有一种副作用被认为与zanidatamab治疗有关。大多数副作用的严重程度为轻度或中度。没有参与者死于与zanidatamab相关的并发症。腹泻是较常见的副作用之一，87名参与者中有32名（37％）经历过。与通过静脉接受zanidatamab有关的副作用，如发冷，发烧,或者高血压,87名参与者中有29人(33%)经历过。
■这项研究的结果支持zanidatamab作为HER2阳性胆道癌患者已经接受化疗后的新疗法的潜力。正在进行更多的研究来支持这些结果。临床试验注册:NCT04466891(HERIZON-BTC-01研究)。
HERIZON-BTC-01研究表明，zanidatamab是标准化疗失败后HER2阳性胆道癌的潜在有效治疗方法。在@hardingjjmd的非专业摘要中阅读更多信息，@DrShubhamPant,和合著者。#BiliaryTractCancer#HER2#zanidatamab.
■在HER2阳性组中，80名参与者中有33名（41％）的肿瘤缩小了原始大小的30％或更多。在这些参与者中，有一半他们的肿瘤在13个月或更长时间内没有生长。低HER2组没有参与者的肿瘤缩小30%或更多。总的来说,87名参与者中有63名（72％）至少有一种副作用被认为与zanidatamab治疗有关。大多数副作用的严重程度为轻度或中度。没有参与者死于与zanidatamab相关的并发症。腹泻是较常见的副作用之一，87名参与者中有32名（37％）经历过。与通过静脉接受zanidatamab有关的副作用，如发冷，发烧,或者高血压,87名参与者中有29人(33%)经历过。
■这项研究的结果支持zanidatamab作为HER2阳性胆道癌患者已经接受化疗后的新疗法的潜力。正在进行更多的研究来支持这些结果。临床试验注册:NCT04466891(HERIZON-BTC-01研究)。
HERIZON-BTC-01研究表明，zanidatamab是标准化疗失败后HER2阳性胆道癌的潜在有效治疗方法。在@hardingjjmd的非专业摘要中阅读更多信息，@DrShubhamPant,和合著者。#BiliaryTractCancer#HER2#zanidatamab.
