Σάββατο, 24 Δεκεμβρίου 2016

PD-L1 TESTING SHOULD BE STANDARD FOR NSCLC

This is Mark Kris from Memorial Sloan Kettering, talking a little further about the tremendous change in our initial treatment of patients with metastatic lung cancers, squamous cell carcinomas, and adenocarcinomas. As you know, data have been presented and made available in the New England Journal of Medicine[1] that have led to US Food and Drug Administration (FDA) approval,[2] and National Comprehensive Cancer Network (NCCN) guideline inclusion,[3] for pembrolizumab as initial therapy for patients with lung cancers if their tumor has greater than 50% PD-L1 expression.
That is great. It gives us another option for patients, but how are we going to do this? How are we not going to have this need to include PD-L1 testing delay the time before patients start treatment? Again, it is a disservice to everybody if we do not find this result quickly. It does not get people onto the drug that could benefit them, and it does not get the majority of people onto chemotherapy who are less likely to benefit from it.
I think the key here is communication. I think we oncologists have a job right now to speak to all the specialists whom we work with in the care of people with lung cancers.
The first thing that the pathologist needs is adequate tissue to perform this assay. I think it is incumbent on us to contact and literally sit down with the people who do the biopsies for suspected lung cancers. As groups, they would be pulmonologists, thoracic surgeons, and interventional radiologists. I think they are all already quite knowledgeable that we need good tissue to make an adequate histologic examination, and that we need sufficient tissue to do comprehensive molecular profiling. We need PD-L1 testing, which is an immunohistochemistry test.
I would urge that whenever lung cancer is suspected or is likely, adequate tissue be obtained for histologic examination, immunohistochemical testing, and comprehensive molecular testing. The time to do it is upfront. While a patient goes through the stages of getting additional staging tests, seeing various specialists before they get to you, this stuff can be cooking and be on your desk when you need to make a decision with the patient.
The other thing we need to do is to sit down with our pathology colleagues. We have just made a tremendous change in their normal flow. In addition to the other information we have already been requesting of them, we now need an additional piece. We need it on every patient. We need it at the first time we see the patient to make these treatment decisions. Number one, they need to understand how critical this is. We need to work with them to make sure that this becomes a standard of care for every patient with a suspected lung cancer.
They are the people with the know-how here. Their expertise is the management of human tissues, and storage and preparation of human tissues. They have a flow within pathology departments. Given the time to do this, they can establish the testing that is needed within the Clinical Laboratory Improvement Amendments (CLIA) requirements of their individual pathology departments. They also can set up procedures within their pathology departments to make this happen, make it happen in every patient, and then to make it happen quickly. The easiest way to do this would be to bundle it with other immunohistochemical tests, such as TTF-1 or p40, that are commonly done to help subtype lung cancers—to lump it in with that.
I should add that our pathologists have done this. They have also added immunohistochemical tests for the ALK and EGFR L858R mutations. They feel that the antibodies, the tests for these molecular aberrations, are quite robust. They feel very confident reporting them. It is also great, when you get the pathology, to have those three things available. Our pathology department has blessedly worked on that. It is now a standard of care for them.
I urge you to spend some time this week in making sure all of your colleagues who help you care for people with lung cancers have been contacted, that they know that we need sufficient tissue for this. We need it on every single patient. We need it for anyone with suspected lung cancer.
As you know, these drugs are also useful in people with small cell lung cancer, although this requirement for the PD-L1 testing is not there. I think that, pretty quickly, it is going to morph to high-level PD-L1 testing in small cell [lung cancer that] will also lead to upfront treatment for the patients. Get the results, and move on that. The way to do this right, and the way to make it happen, is to sit down with your colleagues and present them with the data that you have seen and that they may not have seen.
Make sure that they understand why you are so hot and bothered about this—why it is so important for our patients, why we need it for every single patient, and we need it today. Please be patient and work with them. Just as we have our own procedures and ways of dealing with things, so do they. Try to understand them. Try to find a way to work with them.

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