Kevin Kalinsky, MD, MS

Refining and identifying new biomarkers for risk to better personalize therapeutic strategies in early-stage breast cancer.

Impact

The RxPONDER clinical trial was immensely valuable for identifying the right treatment for patients with early-stage hormone receptor (HR)-positive, HER2-negative breast cancer. In the study, patients were defined by their recurrence score which was calculated based on the results of a genomic test called OncotypeDX®. In those who had a low recurrence score (less than 25), the study found no added benefit of chemotherapy in postmenopausal patients whose cancer had spread to three or fewer lymph nodes. In premenopausal women the opposite was true, they benefitted from chemotherapy. This study was groundbreaking, and Dr. Kalinsky and his team will pursue further research to build upon its findings and make its results more universal and accessible for patients.

Progress Thus Far

There remain a number of questions to address from RxPONDER and Dr. Kalinsky and his colleagues will pursue two separate questions in their study. The first will reassess how menopause is classified in patients. In RxPONDER, menopausal status was based upon self-reported menstrual history, but this can be an imperfect measure. The team is evaluating other methods to classify menopausal status. In the second part of their study, the team is testing an alternative low-cost method for measuring risk of recurrence.

What’s next

The team will explore if menopause can be defined by hormone levels measured in RxPONDER patient samples prior to start of treatment. Initial focus will be on patients who are aged 55 to evaluate if patient outcomes differ based on the method used to define menopause: blood hormone levels versus menstrual history. In parallel, they will evaluate a computer-aided diagnostic method called CHIP (need to spell this out) as a less costly alternative to current tests. CHIP generates a risk score based on image analysis of unique cellular arrangements and characteristics from tumor samples. These studies build on the findings of RxPONDER and will further refine which patients with early-stage, estrogen-driven breast cancer will or will not benefit from chemotherapy—this has the potential to spare some patients unnecessary side effects from chemotherapy.