CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
At the boot camp that preceded the biomarkers conference, the continuing need for education and patient advocacy was made clear in the moving story told to us by a young woman who has two young children. She is a nonsmoker who after several months of severe illness was diagnosed with non-small cell lung cancer. Once diagnosed, her oncologist was so concerned about her failing health that he wanted to start chemotherapy immediately, but her husband, who is not a medical professional, searched the Internet for information and made sure that her health care team tested her biomarker profile. Fortunately, she is with us today in good health because the tests revealed that her tumor was positive for ALK and she was able to receive targeted therapy. Every cancer patient needs an advocate, even those of us familiar with oncology, because a cancer diagnosis is scary and it’s hard to find the right information and make the right decisions under stress.
Conference keynote speaker John C. Ruckdeschel, MD, a University of Mississippi Medical Center oncologist, reviewed the proliferation of tumor markers that can identify actionable mutations. The guidelines (CAP/IASLC/AMP) are inevitably lagging behind the pace of research developments. For example, standard panels of single-gene tests—EGFR, ALK, ROS1, and others such as BRAF—are proving to be insufficient to diagnose and successfully treat all NSCLC. Dr. Ruckdeschel and other speakers insisted that NGS has to be embraced in order for the best available treatment to be selected, particularly for tumors amenable to immune therapy. Reflex testing, even though performed in accordance with guidelines and standard practice, is proving inadequate in many cases.
Single-gene assays are well established, the data are easier to report and interpret, and the assays are less costly than NGS. Therefore, the NGS approach has to be justified by the requester and, in particular, how extensive the NGS testing (sequence limitation) is to be for a particular case. However, selecting the wrong treatment by failing to identify the chief tumor driver causes a delay in implementing the optimum treatment and may introduce complications. For example, the incidence of the rare but serious complication of interstitial pneumonitis following immune checkpoint inhibition therapy varies with tumor type. Also, recently published data suggest that patients treated with immune checkpoint inhibitors who are concomitantly or sequentially treated with TKIs are at greater risk for developing pneumonitis.
As was clear from the presentation on regulation and billing for molecular testing by Timothy C. Allen, MD, JD, professor and chair of the Department of Pathology at the University of Mississippi Medical Center, the new paradigm for cancer therapy is not only presenting major challenges for diagnostic and treatment guidelines but also revealing serious deficiencies in current health care regulations, systems, and procedures for reimbursement. Failure to conform to current treatment guidelines and up-to-date standards of care exposes the medical practitioner to potential tort litigation for negligence or malpractice.
All of which contributes to a growing need for rapid and effective communication between pathologists, oncologists, and patients. Pathology is the foundation for targeted therapy and patient-centered care in oncology. As Dr. Allen wrote recently in The Pathologist, it is important for pathologists to become better communicators to meet new responsibilities as more engaged medical team players, advocating for adoption of new biomarker tests and supporting oncologists in delivering optimal outcomes for patients. As the late Ellen Stovall of the National Coalition for Cancer Survivorship said often, our vision is “to transform each and every person’s experience of living with, through, and beyond the diagnosis of cancer.”
Dr. Nye, whose doctoral degree is in immunology, began her career developing immunodiagnostic tests in London, England. She and her team at Medical Minds specialize in physician and patient education and have developed medical communications in almost every disease category, including oncology diagnostics and therapeutics, during the past 25 years. She led the launch of Rituxan at the BioGenesis Group/Torre Lazur, the agency of record. She is a cancer survivor.