Devan Birch, BA, Gerry Hogue, Nancy Hogue, CPA, Fredrick Ashbury, PhD
The Burden of Cancer
A paradigm shift has occurred in oncology toward precision oncology, in which the molecular profile of the tumor is guiding decision-making for cancer therapies. The last few years we have seen an unprecedented increase in the number of approved novel immunotherapy and targeted therapy agents across different indications. Coupled with this paradigm shift has been the increase in the incidence and prevalence of patients, the significant financial costs of these new therapeutics, and the fact that oncologists are retiring at a rate greater than the number of new entrants into the field.
Costs & Benefits of Precision Medicine
How do we equip community oncologists and what other models of care delivery do we need to manage this cancer crisis? What is the value of precision medicine and how do we deliver this value to providers and patients, so all that are eligible benefit? We designed a study to compare the costs and benefits of precision medicine to standard of care in oncology. The study included 75 advanced cancer patients (45 breast cancer and 30 ovarian cancer patients, stages III/IV) in a community oncology practice setting. Of the 45 breast cancer patients, 27 received precision medicine (PM) therapies guided by genomic sequencing in addition to standard of care (SOC) and 18 received only SOC.
What did we learn?
Precision medicine was more effective.
Precision Medicine patients were more likely to be alive at the time our study concluded compared to those who received standard therapy. Overall, PM was more effective:breast patients were 1.7x more likely to be alive compared to SOC breast patients. PM ovarian patients were 1.4x more likely to be alive compared to SOC ovarian patients alone.
Our breast PM patients had success rates of 78% when precision medicine was added as the second line of treatment, 57% when PM was third line, 100% for patients who received PM as the fourth line, 50% for PM as line 5 and when PM was the 6th line of therapy 50% of patients were successful. The graph to the left shows the relative improvement of adding precision medicine to standard of care contrasted to DeVita success probabilities, respectively, acknowledging these are not yet 5-year numbers.
Our ovarian PM patients also compared favorably, with success rates of 100% for 3 lines of therapy, when PM was added as the third line, 33% when PM was given as fourth line treatment, 100% for PM as the fifth line and 67% for patients receiving PM as line 6. The graph below shows the relative improvement of adding precision medicine to standard of care contrasted to DeVita success probabilities, respectively. (No ovarian patients had only 2 lines of therapy).
Our data showed that PM offers breast cancer patients an average of an additional 26 months of life (and counting) from the time PM treatment was added to standard of care. Our ovarian patient data showed an average of 27 additional months and counting. According to a recent study by Kurzrock and colleagues, patients whose therapies were matched to genomic alterations were more than twice as likely to be alive three years later, compared to those who did not receive genomic-guided therapy or whose therapy had a low degree of matching. These results, together with the VieCure study, support the need for next-generation sequencing of patients' cancers, and, where possible, matching treatment to the genomic profile to improve outcomes.
Randomized trials are expensive and require a long time to get results. Collection of real-world data (RWD), however, can accelerate applications to the Food & Drug Administration (FDA) for approval of drugs for new indications or novel agents by accruing sufficient numbers of patients more rapidly and using analytics to determine patterns. In order to do this in a cost-effective manner, computerized tools that systematically collect RWD are necessary.
Our data, while admittedly involves a small number of patients, supports using NGS testing and adoption of genomic-guided therapies earlier in the process (i.e. moving the use of these technologies to an earlier point in the process to improve outcomes and eliminate waste inherent with failed lines of standard of care therapies.
Overall, further investigation using RWD such as those underlying our study, is necessary. In a subsequent issue, we will describe the financial impacts of precision medicine based on our study.