Premastectomy Radiotherapy and Immediate Breast Reconstruction: A Randomized Clinical Trial

May 21, 2024

We are thrilled  to share that one of our trials, had published positive results, “a pioneering achievement”, as defined by the paper first author Dr. Schaverien.

Dr. Schaverien and the team of researchers at The University of Texas MD Anderson Cancer Center, one of the top cancer care centers in the world, conducted a Phase II trial which tested the feasibility of administering radiation therapy before mastectomy, allowing for immediate breast reconstruction surgery.

The traditional sequence of treatments for breast cancer patients consists in breast surgical removal (mastectomy), radiation therapy and a second surgery, often 6-12 months after the mastectomy, for the breast final reconstruction. During mastectomy, a tissue expander is used as place holder till the reconstruction is completed. This often results in negative quality-of-life impacts and medical complications.

The study enrolled 49 women from participants in the SAPHIRE Trial. Patients underwent mastectomy with immediate breast reconstruction surgery, at a median of 23 days after completing radiotherapy. The trial showed similar complication rates to standard reconstructive surgery, with no flap losses nor disease recurrences after a median follow-up of 29.7 months, while reducing the number of surgeries and minimizing delays.

These findings have led to the design and initiation of the Phase III TOPAz trial, aiming to compare standard radiation treatment with a reduced dose given before surgery.

The full publication on the Journal of the American Medical Association (JAMA) can be accessed here: Premastectomy Radiotherapy and Immediate Breast Reconstruction: A Randomized Clinical Trial | Surgery | JAMA Network Open | JAMA Network

The study was funded by the National Cancer Institute/National Institutes of Health, the Rising Tide Foundation, and other funders.