精准癌医学的创新性临床试验：雨伞试验和篮子试验

2015-12-14 MedSci MedSci原创

美国癌症研究学会（American Association for Cancer Research，AACR）在2014 年的癌症进展里面特别指出，针对精准癌医学的创新性临床试验可分成两大类，一类称为“Basket Trial”，即篮子试验。形象点儿说，某种靶点明确的药物就是一个篮子，将带有相同靶基因的不同癌症放进一个篮子里进行研究就是篮子试验，“Basket Trial” 的本质就是一

MedSci编辑简评：

雨伞试验和篮子试验只是形象说法，其背后的实质是精准医学的理念的临床实践。传统的肿瘤分类标准是按部位（肺癌，乳腺癌等）和形态病理学（腺癌，鳞癌等）结果，而随着对分子表型的认识深入，肿瘤是否可以按分子表型进行划分？按分子表型划分的目的是进行靶向治疗。即同一种表型（如HER2阳性，ALK融合基因等）不同的肿瘤能否采用相同或相似的治疗靶向治疗方案？这就是雨伞试验和篮子试验产生的动机。

当然，肿瘤的分子表型是相当复杂的，随着认识的深入，会带来新的治疗理念的变化，而每一种治疗理念的普及之前，就是临床试验！当您读到这些有意思的文章时，其实更应该考虑到这种伟大理念产生可能会给临床实践带来划时代变化。

原文：

美国癌症研究学会（American Association for Cancer Research，AACR）在2014 年的癌症进展里面特别指出，针对精准癌医学的创新性临床试验可分成两大类，一类称为“Basket Trial”，即篮子试验。形象点儿说，某种靶点明确的药物就是一个篮子，将带有相同靶基因的不同癌症放进一个篮子里进行研究就是篮子试验，“Basket Trial” 的本质就是一种药物应对不同的肿瘤。第二类临床试验称为“Umbrella Trial”，即撑起一把大伞，把具有不同驱动基因的肺癌，如KRAS、EGFR、ALK 拢聚在同一把雨伞之下，这把大伞，就是将不同的靶点检测在同一时间里完成，然后根据不同的靶基因分配不同的精准靶药物。Umbrella试验的最大优势，在于将非常少见的突变事件集中起来，变少见事件为“常见”事件，这无论对加速少见疾病的临床试验还是对于某一个个体获得精准治疗的机会，都具有特别的意义。

1.篮子试验

最有代表性的例子就是ALKoma。ALK 基因突变不但是非小细胞肺癌的驱动基因，也是其他恶性肿瘤包括肺癌、淋巴瘤、肾癌、神经母细胞瘤等的驱动基因。这意味着通过对于同一分子事件的管理，使得带有这种驱动基因的不同肿瘤都能用同一种药物进行治疗。正在进行中的克唑替尼A8081013 临床试验（ClinicalTrials.gov Identifier: NCT01121588）就是一项包括上述各种恶性肿瘤的Basket 试验。除了ALK 之外，EGFR、HER2、BRAF 等基因都可能在不同的肿瘤中发挥驱动的作用，可以往篮子里面装。其中，针对BRAF的研究正在如火如荼地开展着。BRAF 突变可以在多发性骨髓瘤、黑色素瘤、卵巢癌、结肠癌、甲状腺癌、绒毛膜癌、胃肠肿瘤、肺癌等多个癌种中被检出。BRAF V600E 的篮子试验也结束。另外，NCI MATCH(Molecular Analysis for Therapy Choice)试验（NCT02465060）也算是其中之一，针对不同靶点给予针对性靶向治疗药物，而不是按肿瘤病种/部位来划分(Lancet Oncol：一项维罗非尼“篮子试验”结果喜人)。

当然这种研究设计有优点也有缺点。比起原来的实验设计思路，某个特定解剖学位置且含有某个特定突变的肿瘤通常比较少见，收集齐足够的患者数进行大型临床试验会变得很困难，而这种“篮子实验”就帮我们跨越了这个障碍。但是，缺点也很明显，因为要把不同的肿瘤类型相比较，涉及到数据分析统计的问题，此外，临床实验的入组人数较少，那么结果的置信区间就会变大，降低了研究的可应用性。还有就是，肿瘤的解剖学位置真的不用再考虑了吗？从这个实验结果来看，当然不是。

肿瘤的解剖学位置也是疾病治疗和预后判断上也是一个重要的参考因素，不能够完全忽略，此外，对于“含有可治疗靶向”的突变在肿瘤治疗中的意义也不能过度被放大。应该将二者结合起来考虑。

2.雨伞实验。

美国NCI 发起的MASTER试验（ClinicalTrials.gov Identifier： NCT02154490），就是典型的Umbrella临床试验。该研究专门针对鳞癌患者，将其按照不同的生物标志物分为4 组，分别给予针对这4 种生物标志物的相应的药物治疗。

Basket 和Umbrella 这两种类型的临床试验，对精准治疗药物的加速开发和临床肿瘤学的发展，是革命性的创新，因为这两项试验一旦开启，可能不用几年，只需要几十例患者就能够得到加速批准，让药物上市。癌症患者将能更快地用上有效的治疗药物，而不会像过去那样需要7～10 年的漫长时间等待。

由于我们对于肿瘤中突变谱的了解尚不全面，仍有很多突变正在研发中，所以，某些“驱动基因（driver mutation）”或许在几年后就会变成一个“过客基因（passenger gene）”。篮子实验和雨伞实验，构思很好，能够帮我们把临床前期的工作进一步推向临床，可是，一刀切的实验设计，是一个有意义的起步和探索，可它仍然需要进一步的细化和设计。

相关资料：

Hyman DM, Solit DB, Arcila ME, Cheng DT, Sabbatini P, Baselga J, Berger MF, Ladanyi M.Precision medicine at Memorial Sloan Kettering Cancer Center: clinical next-generation sequencing enabling next-generation targeted therapy trials.Drug Discov Today. 2015 Aug 28. pii: S1359-6446(15)00321-9. doi: 10.1016/j.drudis.2015.08.005. [Epub ahead of print]

Zardavas D, Piccart-Gebhart M.Clinical Trials of Precision Medicine through Molecular Profiling: Focus on Breast Cancer.ASCO. American Society of Clinical Oncology. Meeting">Am Soc Clin Oncol Educ Book. 2015:e183-90

Redig AJ, Jänne PA.Basket trials and the evolution of clinical trial design in an era of genomic medicine.J Clin Oncol. 2015 Mar 20;33(9):975-7.

Mullard A.NCI-MATCH trial pushes cancer umbrella trial paradigm. Nat Rev Drug Discov. 2015 Aug;14(8):513-5.

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2016-04-22 忠诚向上

值得学习

94 0
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2016-04-22 忠诚向上

值得学习

147 0
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2016-04-22 忠诚向上

值得学习

43 0
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2016-04-22 忠诚向上

值得学习

55 0
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2016-04-22 忠诚向上

值得学习

103 0
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2016-04-22 忠诚向上

值得学习

127 0
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2016-04-22 忠诚向上

值得学习

105 0

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