本帖最后由 橙色雨丝 于 2019-10-14 20:05 编辑
这是一个很有意思的问题，我专门找来了ECOG-ACRIN 1412的主要研究者，美国梅奥诊所的Grzegorz S. Nowakowski, MD接受采访时就这项研究的结果所做的回答，供参考。
TARGETED ONCOLOGY: What are next steps with this research? 研究的下一步如何考虑？
Nowakowski: It's very interesting because, at the same meeting, there was a study which used a similar design just for patents with ABC DLBCL, adding a lower dose of lenalidomide for more days. This study was actually negative. It was a larger study which did not show the same signal of efficacy that we saw in the phase II study.
这是一个很有趣的问题，因为，在同一个会议上（卢加诺淋巴瘤大会），有一项针对ABC亚型弥漫大B的临床研究（ROBUST III期）采用了类似的设计，加入了较低剂量但时间略长几天的来那度胺。这项研究的结果实际上是否定的。这是一项大样本的研究，没有发现我们在II期研究中所看到的有效率的信号。
I think because we had those two discordant studies, we need to rethink how we can move forward. We looked deeply and tried to analyze what the differences are between the studies and how to best move forward. One way could be the development of new IMiDs or cell modifiers, which could be potent in a similar way to lenalidomide, and there will be room for future studies because we now understand better. Maybe with some of the factors that contributed to the larger study being negative, we could design this study much better.
我想由于现在这两项研究得出了不同的结论，我们需要重新考虑下一步该怎么办。我们对这两项研究进行了深入的分析，试图找出不同之处，以及后面如何来推进。一种办法是开发新的、可能与来那度胺效果类似的免疫调节剂（目前的IMiD包括沙利度胺，来那度胺，泊马度胺）或细胞修饰物，由于我们现在了解的更多了，因此有条件在将来做进一步的临床研究。也许有一些因素导致大样本的研究结果是否定的，我们可以把研究设计的更好。
The other option, which I think could be even more exciting, is taking an additional step forward and using this R2CHOP backbone to add additional agents, which could have synergy with lenalidomide. From this randomized phase II study, we see this very clear signal of activity of lenalidomide added to R-CHOP. There are a number of agents that can synergize with lenalidomide, including some of the monoclonal antibodies like anti-CD19 and others. This includes some of the other targeted agents which can be combined with lenalidomide using this already known, safe, and effective backbone of R2CHOP. Using this doublet of lenalidomide added to R-CHOP, we could possibly raise the bar higher and show the difference more easily, to ultimately cure patients, which is our goal.
另一种办法，可能更加激动人心，是向前更进一步，以R2-CHOP为骨架，再加上更多的、可能与来那度胺具有协同作用的药物。从这项II期随机研究中，我们看到了来那度胺加入到R-CHOP中发挥作用的明确信号。有一批药物可以与来那度胺产生协同效应，包括一些单克隆抗体，例如抗CD19单抗等，也包括其它一些靶向药物可以与安全性和有效性已知的R2-CHOP这个骨架来联合。采用来那度胺加另一个靶向药的双药组合来与R-CHOP进行联合，有可能进一步改善疗效，更容易的显示出在治疗效果上的区别，并最终治愈更多的病人，这是我们的目标。
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发表于 2019-10-14 15:42:18
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发表于 2019-10-14 16:24:19
