It doesn't even seem like a real number but the year 2017 is close. High school freshman this year were not born yet on September 11, 2001, which does not seem like that long ago. 15 years have passed since the day when my generation will always recall where they were when they heard/saw what was unfolding – much like my parent’s generation can tell you about Kennedy’s assassination like it was yesterday.
Nonetheless, pathology in the past four years has changed more than in the 20 years prior to 2013. The advances in cancer biomarkers and immunotherapies have added a new role for pathologists and laboratories. I was fortunate to attend the recent Cancer Biomarkers symposium hosted by Houston Methodist Hospital on the campus of the Texas Medical Center, and the statistics and early data for a number of biomarkers, targeted therapies and directed immunotherapies seems very encouraging. The excitement of oncologists, pathologists and cancer researchers was palpable. Perhaps we finally have some tools in our toolbox that allow for minimally invasive testing, predictive and prognostic assays with companion diagnostics, and therapies with far fewer systemic complications than conventional chemo and radiotherapies.
Among the hope and promise of these evolving companion diagnostics, with many active ongoing clinical trials, is trying to figure out the role of the pathologist to 1) implement these assays in their respective laboratories and 2) educate clinicians AND patients about the testing and results. How should these tests be validated and their ongoing performance monitored? What role does a pathologist have for essentially translating the results for clinicians and ultimately, the patient?
The clinician education part is not new but the patient education part is, and perhaps a new(er) role for pathologists that many of us have no formal training in. 15 years ago patients may have asked about ER, PR and HER2. Their clinicians could inform them whether or not they were “candidates” for anti-estrogen and/or anti-HER2 chemotherapies based upon a quantitative or qualitative report derived from information from clinical trials. “If ‘your tumor’ expresses ER, we will give you this for 5 years” or “If you are 3+, patients like you have seen some benefit from taking this drug to prevent recurrence or metastasis.” But we know this is not 100%. Tumors are heterogeneous, and the way patients may respond or not respond to a particular therapy is very heterogeneous and something pathologists and laboratories are now addressing.
So, we validate the latest marker, implement and test and now report the findings. There is, however, recognition that while a particular tumor may not express, say a programmed cell death ligand, an individual patient may respond to anti-programmed cell death ligand inhibitors OR may express OR not express a particular biomarker in the absence or presence of “pre-sensitizing” adjuvant chemotherapy.
We start to create more questions and issues to address in a healthcare environment now keen on “accountable care organizations” and “population-based” approaches. Finally, we have early biomarkers in a number of tumors that may be personalized, predictive, pre-emptive and/or prognostic in solid tumors beyond breast cancer, for the first time in the last 20 years.
And someone is going to have to communicate the nuances of the testing and results to the patients. Who should do this? The surgical oncologist? The medical oncologist? The pathologist?
Many think, as do I, it’s the pathologist. For 20+ years people have talked about “patient-centric” reports to translate, in simplified terms what “your tumor” and “your tumor markers” mean for you – in writing not above an eighth-grade level for a wider understanding/meaning. It hasn’t happened to my knowledge on a broad scale in any major cancer center organization to date but should. However, it is our responsibility and our challenge.
With lessons learned from the past with biomarkers in tissue, such as warm and cold ischemia, formalin-fixation time, technical issues and inter-observer issues, pathologists have addressed and worked with oncologists to standardize testing and reporting for our patients.
Now is the time that pathologists also work with our clinical colleagues for communicating those results directly to the consumer – the patient.
It won’t be simple or easy, or perhaps welcomed by many pathologists, but anything worth doing is rarely simple or easy, and pathologists need to educate ourselves and our colleagues and our patients in a new role for pathologists in 2017 and beyond.