Titles and Affiliations
Professor and Director, Division of Medical Oncology, Department of Hematology and Medical Oncology, Emory University School of Medicine
Louisa and Rand Glenn Family Chair in Breast Cancer Research
Director, Glenn Family Breast Center
Director, Breast Medical Oncology
Winship Cancer Institute of Emory University
Research area
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 with lymph node involvement. 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 and focusing on the levels of five hormones in serum samples from RxPONDER.
What’s next
There remains an unmet need to more precisely and reliably measure hormone levels, particularly estradiol, to determine whether more sensitive testing could associate with who benefits (or not) from chemotherapy. In RxPONDER, estradiol levels were measured by a standard immunoassay. There are ultra-sensitive tests available to evaluate estradiol. A new goal is to determine whether the improved sensitivity and specificity of ultra-sensitive estradiol tests enhance the ability to determine who may or may not benefit from chemotherapy, or whether ovarian reserve markers, such as anti-Mullerian hormone (AMH) and inhibin B (INHB), remain superior indicators of chemotherapy benefit. This new direction, building on the findings of RxPONDER, 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 more patients unnecessary side effects from chemotherapy.
Biography
Kevin Kalinsky, MD, MS, FASCO is Professor and Director in the Division of Medical Oncology of the Department of Hematology and Oncology at Emory University School of Medicine. He also serves as the director of the Glenn Family Breast Center at Winship where he is tasked with fulfilling the vision to improve breast cancer outcomes by aligning research and education with cancer treatment and prevention. A breast cancer physician and investigator, Dr. Kalinsky’s research involves the development of early-phase clinical trials to assess novel therapeutics in breast cancer based on tumor genomics.
