(dailyRx News) Researchers are competitive types. They have to be to compete for funding for their salaries, lab equipment, even pencils they use. Two researchers have vastly different views about a recently published study on breast cancer radiation therapy. En garde...Fence!
An expert in brachytherapy radiotherapy is disputing the findings of a study published May 1 in JAMA that suggests there are a number of risks associated with accelerated partial breast irradiation (APBI) brachytherapy, compared to traditional whole breast irradiation (WBI).
Robert R. Kuske, MD of Arizona Breast Cancer Specialists, who is co-principal investigator on two major clinical trials, says the MD Anderson study is misleading and could deny women the choice of a safe effective treatment for breast cancer.
The study in question involved reviewing information on nearly 93,000 Medicare claims filed between 2003 and 2007.
The research team, led by Benjamin D. Smith, MD, assistant professor of radiation oncology at MD Anderson, found that compared to traditional radiotherapy, women who had APBI brachytherapy were more likely to need a subsequent mastectomy within five years. These women were also prone to more surgical complications and radiation-related toxicity.
Dr. Kuske begs to differ. He says the study compares WBI to an older form of breast brachytherapy that had less control of radiation dose. He also asserts that the MD Anderson study:
- Is not a clinical trial and shows no difference in survival rates between WBI and brachytherapy.
- Used data from an older machine that could explain the different side effect profile
- Shows only 1.77 percent difference in the rates of mastectomies between the two methods
- Is a retrospective study that looks at the past and uses Medicare SEER database which he says "is fraught with potential inaccuracy, incomplete information, and sampling bias. Studies from this data base are well-known in the scientific community to have unreliable data."
These opposing views come as no surprise to Dr. Smith, who before publication told dailyRx, "These data are certain to provoke considerable debate regarding the appropriateness of ongoing widespread use of brachytherapy outside of a clinical protocol."
When asked about these opposing views, Dr. Smith said, "We appreciate Dr. Kuske’s comments and welcome the academic debate likely to ensue with this publication.
"We would like to point out that this study did not use the SEER-Medicare database, as claimed by Dr. Kuske. The study has been extensively reviewed by peer-reviewers and by expert statisticians and was selected for publication in JAMA."
Dr. Kuske is fearful this research may endanger completion of the Phase III NSABP B-39 study, which has been comparing these two methods since 2005.
This controversy didn't just start. It began when the MD Anderson findings were first presented at the San Antonio Breast Cancer Symposium (SABCS) in December, 2011. A number of groups rose up in defense of APBI brachytherapy, including the American Brachytherapy Society (ABS), the American Society for Radiation Oncology (ASTRO), and the American Society of Breast Surgeons (ASBS).
"We invite all interested parties to read the manuscript carefully when it is fully published in order to gain a greater appreciation for the thoughtfulness with which our analyses were conducted," Dr. Smith wrote in an email correspondence.
Brachytherapy costs about $16,000 to complete, compared to the $8,000 Medicare pays for traditional breast radiation, according to Dr. Smith.