How Will This Change Your Management? Ethical Questions Posed by Tumor Genomic Profiling

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When treating patients, we often ask ourselves how the results of the tests we order will potentially change our management of the patient, or change the way we think about our patient’s disease, or offer information that will enhance our treatment approach.

When treating patients, we often ask ourselves how the results of the tests we order will potentially change our management of the patient, or change the way we think about our patient’s disease, or offer information that will enhance our treatment approach. “How will that change your management?” is a question that my colleagues frequently challenge me with, in thinking about what tests to order for my patients and what tools to utilize to shape my medical decision-making. When are more tests necessary, and conversely, when is the less-is-more approach the way to go?

With the advent of tumor genomic profiling and the molecular stratification of tumors, we have entered into an age of personalized medicine. There has been a transition from single-gene testing to multi-gene testing and now to a much broader approach that can be offered by whole-exome and whole-genome sequencing. The amount of information that’s at our hands can be overwhelming. While the promise of tumor genomic profiling clearly offers the hope of an individualized approach for each patient’s particular cancer, there are both foreseeable and unforeseeable ethical dilemmas that loom. What are the risks and benefits for both cancer patients and providers in the clinical implementation of tumor profiling? This was the topic of a thought-provoking ASCO Education Session entitled “Tumor Genomic Profiling in Cancer Care: Field of Dreams or Ethical Minefield?”

As the discussion focused on the application of ethical principles to our clinical use of tumor profiling, I found many of my own questions and concerns articulated throughout the talk. The principle of “justice and fairness” refers to the ability to offer “equitable access and outcomes for diverse patient populations.” The principle of “respect for persons” raises the questions of how patients should be educated about molecular testing and its implications, how we need to counsel our patients, and whether or not informed consent is necessary. 

As I envision having these types of sophisticated and important conversations with my patients about tumor genetic profiling, I anticipate multiple potentially difficult scenarios. One of my training program’s main strengths is the diversity of patient settings in which we practice. From our city hospital to the VA, to our academic medical center and clinical cancer center, I encounter patients from diverse backgrounds with respect to culture, religion, education, and economic status on a daily basis. First of all, while these tests are theoretically available, it is not always clear when to use them or if they are accessible at any given site. Furthermore, educating a patient about the possibility of incidental findings, such as identifying mutations that we have no treatment for and no understanding of, may be challenging for both the patient and provider. This becomes even more difficult in a setting in which a patient has limited medical knowledge or other barriers-language or cultural. 

Furthermore, the talk raised the question of whether these genetic profiling technologies have been, or have the potential to be, “over-adopted.” While position papers exist, there are currently no strict oversight or regulatory committees that govern the use of tumor profiling in the clinical setting. Should this testing be only under the auspices of a research study with informed consent, or can these tests be used alone in the clinical care setting? Is there an obligation to report all the details of the tests to each patient, even when we ourselves as physicians may be unsure how to interpret the results? Where does our professional responsibility lie in reporting findings, and do we need to follow up on potential secondary findings? And ultimately, will the results of these tests change our management for our patients? At the present time, I think the answer is unclear. However, for the future, I believe the answer will be yes. 

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