Comprehensive discussion on how best to interpret and document results from biomarker testing, along with considerations for communicating results with other healthcare professionals.
Timothy J. Pluard, MD:Both of you have alluded to the fact that we’re relying almost exclusively on next-generation sequencing panels that are commercially available. Give me a sense of the pragmatic aspects of getting a specimen and a biopsy in pathology. How do we order the testing? How do we get it sent out? More important, how do we get that information into the clinical record in a meaningful and useful way so that it’s actionable for oncologists at the bedside?
Sujith R. Kalmadi, MD: In our practice, we work as a team, like in a team sport. I try to make sure that not much of the tissue is spent at the local level doing immunohistochemistry [IHC] stainings. If I need testing done, I usually write on my biopsy specimen to send it to this particular company for next-generation sequencing because I don’t want to use up tissue with IHC after the initial diagnosis is done. That’s No. 1. No. 2, I worry about the information not reaching. Some of these companies have started breaking up their results and sending them in 2 or 3 installments. Because of that, we had a big project with all these testing companies to have a direct link with our electronic medical records. We use something called OncoEMR from Flatiron [Health], and we’ve been able to do that because of a conduit that we created so all the results automatically come into this.
Some of these companies are offering us OCR, optical character recognition, so that when results come into our system they automatically get into our electronic medical records. For instance, if it’s HER2 [human epidermal growth factor receptor 2] low, it goes in directly because the machine can sense that. It’s all artificial intelligence built in, and that’s been a big help for us.
Timothy J. Pluard, MD:Ossama, from the pathologist’s standpoint, when these tests are sent to third-party commercial sequencing labs, what’s the role of the pathologist, in terms of helping clinicians interpret those results?
Ossama Tawfik, MD: Pathologists play a critical role as an intermediary and an active participant by sending cases to reference labs. It starts by making sure we’re collecting adequate material. That’s a critical step. If you don’t have a sample to work with, you’re frustrated. Patient care will be delayed, and that can lead to bad outcomes because of that tremendous delay. It’s important to make sure we’re sending adequate material the first time around so everybody has what they need to successfully provide service for the patient.
Once we get the information back, we need to make sure we relay in an appropriate way. Some of those are 25 pages long. Some actionable results are there, and some unknown results are there. You don’t know what’s relevant and what’s not. Pathologists with expertise and the team should be able to guide you. You alluded to the IT [information technology] part. Unfortunately, we don’t have a sophisticated way of integrating the data appropriately and providing them to clinicians in real time to guide you and make sure they’re integrated into your medical records with the pathology report in front of you, so you don’t have to chase it everywhere in the electronic medical records. To this day, this is very frustrating and fragmented, and it needs a lot of improvement.
Timothy J. Pluard, MD:I agree, Ossama. Both of you have identified the sheer amount of data coming back. How to identify those actions and all pieces of data in real time remains a challenge.
Samuel K. Caughron, MD, FCAP: Communication among all members of the team, including the medical oncologist, the pathologist, and the interventionalist or proceduralist who’s collecting the sample is 1 of the most important aspects of a successful program for biomarker testing in any institution. The pathologist begins by making clear to the proceduralist what sample they’re going to need. On any given patient, when a sample is being collected, the best practice is for the pathologist to interact directly with that proceduralist on that patient at the time of collection, to provide feedback on whether an adequate sample has been collected. Similarly, communication between the oncologist and pathologist, at a system level, looks at what biomarker testing should be part of the testing that’s offered by the pathology department, and how it’s going to be facilitated when that testing is required.
It’s then about identifying protocols for when the pathologist can initiate testing for specific sample types or biomarkers and in what particular scenarios. After the testing has been done, it’s essential that that loop is closed. A report will eventually go back to the treating physician and the treating team. But in an ideal environment, the pathologist also sees that report and knows the findings in a particular patient’s malignancy or scenario. Then it’s important to communicate back to the rest of the care team about what has been found, the significance, and any technical aspects. Were there adequacy issues with the sample in a patient who had a negative result that may have impacted it? If an unusual mutation has been found, are there reasons to think differently about an unusual mutation other than just a straightforward mutation that’s been identified? Communication across all members of the team is a crucial aspect of a successful biomarker program.
Transcript edited for clarity.