The breast cancer treatment brachytherapy, heralded for its low complication rates, actually results in more complications than whole-breast radiation 1 year after treatment.

For women 66 years and older with early-stage breast cancer, the standard treatment includes breast-conserving surgery typically followed by radiation therapy to reduce the risk of recurrence. Whole breast irradiation irradiates larger areas of the breast, whereas brachytherapy temporarily implants radiation sources in catheters within the surgical site to deliver larger and fewer radiation doses directly to the affected breast tissue. Brachytherapy results in a shortened treatment time and, according to its proponents, decreased toxicity to surrounding healthy tissue.

To test the theory behind brachytherapy, a research team studied a national sample of approximately 30,000 women with Medicare coverage. Among patients undergoing radiation therapy, 15.8% received brachytherapy in 2008-2009, which was up from less than 1% in 2000 and 10% in 2006. Across the United States, the use of brachytherapy varied substantially, from less than 5% of patients in some areas to more than 70% in others.

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The use of brachytherapy was associated with a 16.9% higher rate of wound and skin complications in the year after treatment compared to whole breast irradiation. The two treatments had no significant difference in the rate of deep tissue or bone complications.

“Despite the absence of large randomized controlled trials comparing these two treatments, brachytherapy has become increasingly popular, in part because of a theoretically lower rate of complications,” said the study’s lead author Cary P. Gross, MD, associate professor of internal medicine at Yale School of Medicine. “This study highlights the importance of conducting comparative effectiveness research before a new treatment becomes widespread. Medicare is spending significantly more money to cover this treatment, which potentially exposes women to a higher risk of complications than the ‘tried and true’ whole breast irradiation.”

An accompanying editorial by Jennifer L. Malin, MD, of the University of California, Los Angeles, explained that the culture of oncology approaches each new treatment or technology with tremendous optimism that it will result in improved outcomes. She explained that this study and others in comparative effectiveness research (CER) “highlight the important role CER can have in providing data on therapies for which outcomes from randomized clinical trials are lacking.”

These findings and the editorial were published in the Journal of Clinical Oncology (2012; doi:10.1200/JCO.2012.43.5297 and the editorial at doi:10.1200/JCO.2012.45.4660).