The era of precision medicine in cancer care is rapidly evolving. But this concept is not new. Precision medicine has been around for decades. In fact, one of the earliest ideas of finding the right treatment for the right patient based on the characteristics of their tumor was seen with the introduction of tamoxifen for hormone-positive breast cancer in the 1970s. Since then, tumor characterization has become more sophisticated with improved diagnostic testing, including the application of genomic testing.
Genomic testing to identify novel treatments for patients has now become a large component of precision medicine. This has led to a deeper understanding of tumor biology, an increase in molecular- or biomarker-driven clinical trials, as well as the advancement of drug development. NCCN guidelines now recommend upfront broad panel molecular testing for advanced or metastatic non-small cell lung cancer. Benefit of upfront broad panel molecular testing in various gastrointestinal malignancies was also demonstrated at the 2020 Gastrointestinal Cancers Symposium.
Identifying Challenges, Finding Solutions
Genomic testing is routinely performed on tumor biopsy or blood test. However, confusion can arise when clinicians are presented with these test results because not all mutations will have an actionable treatment option. In addition, it is not always clear if a mutation in a patient's tumor is a "driver" (a mutation that may be driving cancer growth) or a "passenger" (a mutation which may be present but not driving cancer growth). Another challenge facing clinicians is how to determine which targeted therapy presented is best for their patient. Once a therapy is finally selected to pursue, if it is not on-label for that particular cancer, challenges around how to obtain it will persist.
The solution to all these issues is not an easy one. Most clinicians will not have received training or education with interpreting and applying these test results on their patients. Many genomic testing companies may provide a resource line where clinicians can speak with a genomicist for further clarification on the test results. However, many institutions with precision medicine programs are now developing molecular tumor boards that can provide further evidence-based discussion to answer these questions.
Molecular tumor boards are now being held at academic centers often with in-house genomic testing. Other academic and community cancer centers are also participating in molecular tumor boards, sometimes in collaboration with genomic testing companies. In these situations, patient cases are presented along with relevant pathology and radiology. In addition, their genomic test results are also discussed. In this type of collaborative environment, better understanding of these mutations as well as their relevance to specific cancers can be further characterized. Treatment plans are made based on real-world evidence, published literature, and active clinical trials. Often, these molecular tumor board discussions may also generate the need for some patients to seek genetic counseling. Certain mutations or tumor signatures may suggest a germline abnormality where further testing is required to confirm its genetic basis.
How to Manage So Much Data?
As more genomic testing is done, cancer centers will acquire numerous test results that can be difficult to maintain. Currently, most electronic medical records (EMRs) do not provide the ability to display these results in a searchable or clinically useful manner. Often, these reports are scanned into the system. One solution is to integrate the test results within the EMR. There are third-party companies that may help with this integration to make test results more accessible to clinicians, as well as easy to incorporate into progress notes. Future directions may also involve clinical trial matching or potentially similar patient matching to better obtain real-world, real-time data sets. Adding this technology infrastructure can help clinical decision making and creating treatment pathways which may deliver greater value.
Organized, well-cultivated data is going to be necessary to fully capture the importance of this genomic information. This data will help identify which specific patient populations will respond to certain treatments, as well as help identify those who may not. By accruing this data, better, more effective and possibly less toxic treatment options may be provided.
Improving Precision Medicine Programs
Precision medicine programs are most successful when there is collaboration between hospital administration and clinicians. Organizing a precision medicine committee can help generate evidence-based pathways for diagnosis and treatment, which can also be cost-effective. Patients benefit from this comprehensive diagnostic approach and potential treatment options by receiving targeted therapies or enrollment onto clinical trials. Many umbrella and basket clinical trials based on genomic test results are currently enrolling patients. Medication acquisition programs can also help patients receive therapies based on their genomic test results if they are ineligible for a clinical trial.
Future Direction
The cancer care and treatment landscape is growing rapidly and the field of precision medicine is dramatically changing this landscape. Genomic testing is a big part of this field and, as more and more clinicians order these tests for patients, a better understanding of the value will be needed.
Precision medicine programs are going to be necessary at cancer centers to ensure we provide patients with the best treatment options for their genomic test results based on current evidence. Cancer centers will need to create organized programs to be able to offer these tests, interpret results, and implement therapies for their patients.
Data derived from this testing will need to be integrated into hospital EMRs so clinicians can easily search for results and implement the right treatment strategy. As more data is collected, next steps will be to manage this data to help identify groups of patients such as those likely to respond or be resistant to certain therapies. By understanding tumor biology and heterogeneity better through genomic testing and data analysis, we will continue to improve patient care.
ANKUR R. PARIKH, DO, is the Medical Director of Precision Medicine at Cancer Treatment Centers of America (CTCA) and practices at CTCA Philadelphia.