Oncology Frontier: Targeted therapy is the hottest and most rapidly developing area in oncology today. The US FDA has approved several novel targeted drugs based on the pathological complete response rate (pCR) from clinical trials. Do you think the FDA rushed a little with the novel targeted drugs， since some trials showed that pCR did not always translate into clinical benefit， such as improvement of survival?

 

　　《肿瘤瞭望》：鉴于靶向治疗药物的蓬勃发展，美国FDA已经基于病理学完全应答率批准了多种靶向治疗药物。然而，有研究显示，至少在某些时候，病理学完全应答率并不等于生存期延长等临床获益。您是否觉得FDA批准新药上市的步伐迈得太大了呢？

 

　　Dr Kerr: I think， by and large， the FDA is a great organization but it is always a lose-lose situation for them; they are damned if they do and they are damned if they don’t. They are under pressure to approve as many exciting interesting new drugs as possible， but at the same time， to make them as absolutely safe as possible. Looking at clinically impactful endpoints， people are often looking at surrogates; endpoints that can be assessed much more quickly in much smaller patient cohorts. Looking at pathological complete response seems a very logical way to measure the effectiveness of a new cancer drug. The problem is whether we can correlate pCR with long-term clinical benefit like improved overall survival and quality of life. The jury is still out on that. In some situations in some cancers the answer is yes， but in many not. Therefore， I don’t think we could use pCR across the board as an effective surrogate marker for something like survival.

 

　　Kerr教授:总的来说，我认为FDA是一个庞大的组织，但是他们总是两面受伤，他们做或不做都不对。他们在压力之下批准尽可能多的令人兴奋和有趣的新药，但同时也要保证他们尽可能地安全。纵观那些有临床影响力的终末事件，人们总是看到替代者；终末事件在一些小的患者群体中更容易评估。着眼于病理完全反应（pCR）似乎是评价新型抗肿瘤药物有效性的非常符合逻辑的方式。问题是我们是否能将pCR与长期临床受益如提高总生存期和生活质量联系起来，评审团还没有定论。在某些条件下某些肿瘤中答案是肯定的，但是在很多情况下却是否定的。因此，我认为我们不能完全将pCR作为生存等事件有效的替代标志。