ASCO 2015:ASCO宣布两项精准医疗试验计划--TAPUR和NCI-MATCH

2015-06-07 MedSci MedSci原创

  Richard L. Schilsky教授6月1日,2015 ASCO年会新闻发布会宣布了TAPUR和NCI-MATCH两项临床研究计划,这两项研究将致力于扩展精准医疗的范畴。前瞻性非随机TAPUR临床试验将在包括晚期实体瘤、多发性骨髓瘤和B细胞霍奇金淋巴瘤等存在药物靶向基因组变异的多种类型癌症中,采集有关于市售癌症靶向药物抗肿瘤活性和毒性反应的信息。启动时TAPUR将评估由5家药企

  Richard L. Schilsky教授

6月1日,2015 ASCO年会新闻发布会宣布了TAPUR和NCI-MATCH两项临床研究计划,这两项研究将致力于扩展精准医疗的范畴。

前瞻性非随机TAPUR临床试验将在包括晚期实体瘤、多发性骨髓瘤和B细胞霍奇金淋巴瘤等存在药物靶向基因组变异的多种类型癌症中,采集有关于市售癌症靶向药物抗肿瘤活性和毒性反应的信息。启动时TAPUR将评估由5家药企捐助的10~15种药物,依据肿瘤类型、基因组异常和药物定义的队列将最多纳入24例患者。患者纳入预期将在年底前展开。

基于综合纳入/排除标准,患者将接受筛查以确定其健康度是否足以参与试验。如果患者符合试验标准,经治医生将从TAPUR研究方案可用药物中选择一种针对患者肿瘤基因变异的药物。如果相关的药物-靶向配对在方案中未明确,医生可咨询分子肿瘤委员会;委员会将评估病例的临床和遗传特点,并对研究潜在治疗应用与否做出推荐。TAPUR的主要终点为RECIST定义的肿瘤客观应答;其它终点包括无进展生存期(PFS)、总生存期、治疗持续时间和治疗相关性严重不良事件。

ASCO首席医疗官Schilsky博士表示,TAPUR将对肿瘤日常实践中的分子靶向和潜在治疗探讨信息加以利用;由于目前缺乏了解患者超说明书应用靶向药物经验的途径,因此现阶段此信息源尚未得到利用。机构审查委员会将于下个月对研究方案和知情同意书加以评估。ASCO设立了指导委员会、分子肿瘤委员会以及数据和安全监督委员会,涉及成员将包括患者代表、临床肿瘤医师、统计学家和基因学专家。

ASCO将对研究的运作事宜加以赞助和组织,其中包括协调多方合作,如患者、医生、ASCO监督委员会、药企、科技公司和社区研究基地。TAPUR临床研究地点计划将扩展至全美。ASCO还将与荷兰个体化癌症治疗中心合作并共享数据;该中心正在实施的一项临床试验采用了与TAPUR极为相似的研究方案。

Ⅱ期NCI-MATCH试验整合了以特定基因突变为靶点的20余种在研药物或药物组合,从而将试验中的各例患者与针对其肿瘤分子异常的治疗加以匹配。启动时计划开展10个子研究,并在数月内将子研究增至20个以上。患者招募将从2015年7月开始。患者纳入后将首先接受筛选;在此期间其肿瘤样本将接受活检和测序,从而检测可能促进肿瘤生长以及可能成为在研药物靶点的遗传异常。如果检出的患者基因突变符合某项子研究条件,患者则接受进一步评估以明确其是否符合入组标准。入组之后患者将在肿瘤缩小或保持稳定的情况下持续接受靶向药物治疗。

研究者计划在研究期间筛查至少3000名患者,并以纳入约1000名患者为目标。研究设计要求至少四分之一的患者患有罕见肿瘤(非小细胞肺癌、前列腺癌、乳腺癌结肠癌之外的癌症)。受试者必须年满18周岁,伴有至少一次标准全身治疗后进展的实体瘤或淋巴瘤,或无标准治疗的肿瘤。两项研究肿瘤将被加以评估:客观应答率(ORR;主要终点)和6个月PFS(次要终点)。在接受分子靶向治疗的亚组人群中,16-25%的ORR和≥35%的6个月PFS将被视为具有应用前景的结果。此项研究由NCI和ECOG-ACRIN癌症研究组共同制定实施,属于NCI资助的国家临床试验研究网络的部分内容。

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    2016-02-09 lanyan20020086
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    2016-01-22 lyh994

    期望有好的结果

    0

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    2015-09-16 quxin068
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    2015-07-28 ligong

    精确治疗,靶向治疗仍需要很长的路要走!

    0

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    2015-06-09 huaxipanxing

    看看

    0

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    2015-06-09 bsmagic9138
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    2015-06-07 lovetcm

    最多纳入24例患者,还是处于探索阶段

    0

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