The trial accrued over half of its patients from the MD Anderson Cancer Network®. In addition to MD Anderson, patients were enrolled from the institution's Houston-area locations, Orlando Health (formerly MD Anderson Orlando) in Orlando, Fla. and Banner MD Anderson in Gilbert, Ariz.
"This was the first investigator-initiated randomized trial conducted in the network," said Benjamin Smith, M.D., associate professor of Radiation Oncology. "It was a success because of the support of our partners and illustrated the potential, promise and power of our network to help achieve our mission."
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All participants were at least 40 years of age and previously had been treated with breast-conserving surgery. Seventy-six percent were overweight or obese according to their body mass index. The researchers used validated tools to gather patient-reported outcomes (PROs) on cosmetic, functional and other quality-of-life measures; physicians rated cosmetic results following treatment. Assessments were performed at baseline, six months, and at one, two and three years following treatment.
"There were no significant differences between the treatment arms for any PROs at baseline, six months, one year or three years," said Swanick. "At two years, outcomes from the Functional Assessment of Cancer Therapy Breast trial outcome index were modestly higher in the hypofractionated group."
There were no significant differences in physician-reported cosmetic scores at any time point. Additionally, both patient groups reported similar improvements in breast pain and functional assessments over time.
The researchers continue to follow tumor control outcomes, though no meaningful difference in survival has been found, to date. The study has several limitations, such as a lack of complete data through three years for all patients at the time of last follow up. All outcomes will be reported once all patients have completed three-year follow up. Further, patients and physicians were not blinded to treatment arms, which has the potential to bias the reporting outcomes.
The results of this and previous studies further support the use of HF-WBI as the preferred radiation therapy for early-stage breast cancer patients, explained Smith. "At MD Anderson these shorter courses have become the standard of care."
Smith currently leads an ASTRO guideline panel on whole-breast irradiation, and hopes these and other data will support development of evidence-based treatment guidelines for early breast cancer.
