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Dr. Jack West is a medical oncologist and thoracic oncology specialist, and Executive Director of Employer Services at the City of Hope Comprehensive Cancer Center in Duarte, CA.

Serum Test Being Launched to Test for Likelihood of Benefit from Oral EGFR Inhibitors
Sat, 02/21/2009 - 15:47
Howard (Jack) West, MD, Associate Clinical Professor, Medical Oncology, Executive Director, Employer Services, Founder, President and CEO of GRACE

About 18 months ago, I wrote a post about a new technique being developed that looks at the pattern of proteins in the blood of a patient in order to determine whether a patient is likely to do well or poorly after receiving an EGFR tyrosine kinase inhibitor like tarceva (erlotinib) or iressa (gefitinib) for advanced NSCLC. This work was the product of collaborative work among folks at Vanderbilt University, the University of Colorado, and a Colorado based company called Biodesix.

At the time that I wrote the original post, there was a general plan to bring this test to commercial use. Earlier today, I met with some of the folks at the company, who told me that this plan is now moving forward, with a plan to launch the test, now known as Veristrat, in early March. While they didn't have additional published or formally presented information to highlight, they told me that they have continued to do studies of the serum from patients from all over the world that has validated what their test is trying to do. Here's the idea:

A small blood sample from the patient is sent to the company. They do a proteomic analysis (described in my prior post on the subject) and provide a result within 72 hours, separating patients into a "Good" and a "Poor" group: about two thirds are classified as "Good", one third as "Poor". What this test predicts is how patients will do after receiving an oral EGFR inhibitor.

Their work indicates that this isn't just a marker of whether someone will do well or poorly in general, but specifically how they will do with an EGFR inhibitor, and that the people who are in the "Poor" category have a faster progression on an EGFR inhibitor than with a placebo, so it isn't just ineffective, but even harmful treatment. The benefit of the test is to identify patients who should not receive an EGFR inhibitor, rather than to say that someone is going to do particularly well with one. I think that this is certainly valuable information, but I wonder if many patients won't be that anxious to discard this potential treatment, even if they test in the "poor" category.

Still, for patients in the "poor" category, this information would save the cost of a likely ineffective therapy for them, with side effects that are difficult for some people, and the treatment may even be detrimental for them. Because these patients often have alternative choices like chemotherapy available, knowing ahead of time that an EGFR inhibitor would be especially unlikely to be helpful seems like a valuable piece of information to have. And even for the patients who we would consider likely to benefit from an EGFR inhibitor, such as a never-smoker or a woman with an adenocarcinoma NSCLC tumor, for whom we might consider giving an EGFR inhibitor very early, it could be helpful to have a test that can give you an answer within 3 days about whether that might be a mistake.

I'd welcome your thoughts about how interested you'd be in potentially eliminating a treatment that could be a source of hope, but also could be a waste of time, money, and even be harmful in a subset of patients.

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