WEBCAST | Product Development

Esserman brings urgency for ‘learning healthcare’ to learn faster, better

Breast cancer pioneer tells The BioCentury Show how I-SPY2.2, WISDOM trial and EHRs can tailor better treatment to more women

June 2, 2022 1:14 PM UTC

Laura Esserman wants to raise the bar on turning treatment outcomes into better patient care, and the speed at which healthcare systems can learn from the data they generate. On the latest episode of The BioCentury Show, she carries this thread through a discussion on the next phase of the I-SPY 2 trial, ensuring diversity in clinical trials, and initiatives to expand the adoption and utility of electronic health records.

Esserman, a professor of surgery and radiology at the University of California San Francisco and director of UCSF’s Carol Franc Buck Breast Care Center, is one of the principal architects of the I-SPY 2 breast cancer adaptive trial, which aims to advance precision medicine by using molecular signatures to drive treatment paradigms.

In the next stage, I-SPY 2.2, she wants to spare patients from needing to take toxic chemotherapies — the default path — if they’ve responded well to the treatment arm. With this and other initiatives, she aims to accelerate the pace at which clinical trials and clinical practice learn from outcomes and adapt. 

“We have to change our expectation of how fast we can learn. We can do so much better,” said Esserman.

Acknowledging that “one size doesn’t fit all,” her mission is to use early endpoints, in particular pathological complete response (pCR), to find which patients are responding and modify the treatment course accordingly. “Once you get to pCR, adding more drugs doesn’t help you,” she said. 

Esserman also outlined how ensuring proper representation in trials is translating into actionable data. For example, once I-SPY 2 increased participation of African American women to 12% of the trial population, there were sufficient data to establish that in triple-negative breast cancer, the response to checkpoint inhibitors and the three and five-year survival is the same as the average trial population if they have a complete response. Conversely, in hormone receptor-positive, HER2-negative disease without a complete response, outcomes for African American women were worse.

Esserman is also addressing the need for diverse populations to participate in trials via the WISDOM study and working with FDA to advance the use of EHRs and create a set of tools that work across institutions. This is key, she said, to understanding how existing and new treatments are working in the real world.

Engaging the public in joining trials and understanding the value of their data for improving healthcare is high on her list of priorities. “Making sure your data can be used for part of this helps you, helps your daughter, helps your son, helps your friend, helps your mother,” is an important public health message, said Esserman.

The BioCentury Show is sponsored by pathfinder partner Sofinnova Investments. For information on how to sponsor The BioCentury Show and the BioCentury This Week podcast, please contact Sarah Shoaff at