The trial was small, including just 67 women with stage II to IIIa breast cancer at Huntsman Cancer Institute at the University of Utah and Rutgers Cancer Institute of New Jersey. Patients received higher levels of radiation for 15 days, compared to the traditional delivery of somewhat lower levels for 30 days. The women were then followed for an average of 32 months to determine whether higher daily doses of radiation increased the risk of infections, wound healing and other complications.
The women fared better than researchers expected, having fewer side effects and lower rates of recurrence. They experienced less skin redness (a common side effect of radiation therapy) and less fatigue than women typically experience after 6-week sessions. No significant toxicities were found.
Only half of women had breast reconstruction; related complications were similar to what has been observed in other trials with a longer course of radiation. Study coordinator Matthew Poppe, MD, said, “We hope in time this will result in improved cosmetic outcomes, as other studies have shown that by shortening the course of radiation, cosmetic outcomes are improved.”
The study was designed in an effort to improve the quality of life for women who need radiation after mastectomy. A shorter, effective course of radiation would hopefully be less stressful and more convenient for many patients. They would be able to spend less time away from home, and return to work sooner. It would also be more beneficial (and potentially lifesaving) for many women who forego treatment because they don’t live near a cancer center or other facility that provides radiation therapy.
A phase 3 clinical trial of the shorter radiation course is scheduled to begin later this year. It is expected to enroll about 900 patients at various cancer centers in the U.S. and Canada.
Reference: Khan AJ, Poppe MM, Goyal S, et al. “Hypofractionated Postmastectomy Radiation Therapy Is Safe and Effective: First Results from a Prospective Phase II Trial.” Journal of Clinical Oncology 2017; Jun 20;35(18):2037-43.