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Laura J. Esserman, MD, MBA
Professor of Surgery and Radiology
Director, Carol Franc Buck Breast Care Center
Co-Leader, Breast Oncology Program
UCSF Helen Diller Family Comprehensive Cancer Center
University of California
San Francisco, California
- Seeking to identify biomarkers that can predict response to therapy or risk of recurrence.
- Tumor infiltrating immune cells are analyzed to identify biomarkers of response to immunotherapies.
- This research will lead to more personalized and effective cancer care by advancing immune-based diagnostic and therapeutic strategies to the clinic.
Ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer, is a non-invasive, early form of breast cancer. While most DCIS will not progress to invasive cancer, there are no reliable biomarkers that can identify those that will. Because of this, the recommended treatment is the same for all DCIS patients–surgery, radiation and hormone treatment. Dr. Esserman’s research has shown that high risk DCIS contain high amounts of immune cells. She is now testing whether high dose immune-therapy can prevent these DCIS from becoming malignant.
Full Research Summary
Interactions between tumor cells and host immune cells are quite complex, and are not adequately characterized by conventional staining techniques, nor by assays that analyze single tumor cells. Dr. Esserman’s team is utilizing new technologies for multiplexed analyses of immune cell infiltrates with the goal of bringing immune-based diagnostic and therapeutic strategies into the clinic.
The team recently demonstrated that the most aggressive DCIS (high grade, large, palpable) lesions tend to have high levels of immune infiltrates. The group therefore proposed a unique strategy to potentially reverse these high-grade DCIS cells by directly injecting immune checkpoint inhibitors into the breast lesions themselves.
They recently completed a small dose-escalation study of direct injection of the immune checkpoint inhibitor pembrolizumab into DCIS. No systemic toxicities associated with this treatment were found, even at the highest dose tested (unlike intravenous dosing of this drug). A significant increase in tumor killing immune cells within the DCIS lesions was observed in the majority of patients. Over the next year, the team will expand this study to treat 30 women with high-risk DCIS at the highest dose used in the dose-escalation phase and will increase the number of doses from two to four.
Dr. Esserman is a surgeon and breast cancer oncology specialist, and is the Director of the Carol Franc Buck Breast Care Center at the University of California, San Francisco (UCSF). In 1996, she started the Center of Excellence for Breast Cancer Care at UCSF to integrate clinical care and research, automate tools for the capture of patient and clinical data, and develop systems to tailor care to biology, patient preference, and performance.
Dr. Esserman is nationally and internationally known as a leader in the field of breast cancer and has published over 200 articles. She served as a member of a taskforce for President Obama’s Council of Advisors on Science and Technology (PCAST) Working Group on Advancing Innovation in Drug Development and Evaluation. The group was tasked with making recommendations to the federal government about how to best support science-based innovation in the process of drug development and regulatory evaluation.
She is the Principal Investigator of the I-SPY TRIAL program, a multi-site neoadjuvant clinical trial (which includes a phase 2 and 3 trial) that has evolved into a model for translational research and innovation in clinical trial design. Dr. Esserman has recently launched a University of California-wide breast cancer initiative called the Athena Breast Health Network, a program designed to follow 150,000 women from screening through treatment and outcomes, incorporating the latest in molecular testing and web-based tools into the course of care. Athena is in the final stages of launching a statewide demonstration project and phase 1/2 trial of personalized screening.