Oncology Frontier: Dr. Loibl， could you introduce some of the useful approaches to evaluate the tumor response of neoadjuvant therapies?

　　《肿瘤瞭望》：能否请您介绍一下我们应如何评价肿瘤对新辅助治疗的反应？

　　Dr. Loibl: Well， neoadjuvant therapy in breast cancer can of course be evaluated clinically， so you measure the tumor just by physical examination or by ultrasound， but of course this is less reliable than if you measure it upon surgery. In surgery you take the tumor out and then you measure it and stage it according to the ypT status， this means there was not any adjuvant therapy， and then you measure the tumor. Actually if there is nothing left， no invasive or non-invasive residuals then you have a pathologically complete response.

　　Loibl教授：当然，乳腺癌的新辅助治疗可以进行临床评价，通过查体或超声检查即可评价，但这种评价的准确性比基于手术的检测相对较差。在进行外科手术时，我们可以将肿瘤取出检测并根据ypT进行分级，这意味着在不受其他任何辅助治疗影响下即可对肿瘤检测。实际上，如果患者体内无任何浸润性或非浸润性残留，则实现了病理完全缓解。

　　Oncology Frontier: Turning our attention to the trials， what can be said about the use of neoadjuvant endpoints in breast cancer trials?

　　《肿瘤瞭望》：什么可以作为乳腺癌研究中新辅助治疗的终点评价标准？

　　Dr. Loibl: Well， in the neoadjuvant trials， we usually use the pCR， the pathological complete response endpoint evaluated by the pathologist， but of course we can define it differently. If there is no invasive and no non-invasive residual left in breast and in nodes with pCR， but sometimes you include the DCIS residuals and still it is a pCR and there is a much looser definition. If you do not take into account the lymph nodes and just have a look at the breast， but these are different definitions and of course if you compare clinical trials then you have to know what the definition of the pathological complete response is.

　　Loibl教授：在新辅助治疗相关试验中，我们通常应用由病理学家评估的病理完全缓解（pCR）作为终点。当然，不同试验中pCR定义可能有所不同。一般情况下，如果患者乳腺或淋巴结中无浸润性或非浸润性残留，则可视为达到pCR。不过有时还需考虑是否存在导管内原位癌（DCIS）残留，若仍存在，采用相对宽松定义仍可视为其已达到pCR。如果不考虑淋巴结而只考虑乳腺，对pCR的定义可能又有所不同。当然，要想对不同临床试验进行比较，我们必须清楚pCR的定义。

　　Oncology Fronier: In the trials where pCR is the endpoint， is it a reliable to associate that with meaningful change in long term outcomes?

　　《肿瘤瞭望》：在以pCR为终点的临床试验中，pCR是否是反映长期结局变化有意义的可靠指标？

　　Dr. Loibl: this is a very good question actually， but this really depends on the tumor’s biology. We know that in the triple negative breast cancer and in the HER-2 positive and probably here especially in the hormone receptor negative breast cancers， if you have a pCR increase of about 20% then you can expect this translates into a survival benefit.

　　Loibl教授：这是个非常好的问题。我认为，这可能取决于肿瘤的生物学特性。据我们所知，对三阴性乳腺癌、HER-2阳性乳腺癌及激素受体阴性的乳腺癌而言，若pCR增加20%则能为患者带来生存率改善的获益。