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June 19, 2017

"Among several shortcomings of the San Antonio study data," said Dr. Kuske, is the fact that it covers "an antiquated balloon catheter with a single channel. Since that time, technology has dramatically improved to encompass the use of newer, multichannel applicators. The side effects and toxicity seen with these modern technological advances are far less than the results presented in the study."

Also critical of the data was Peter Beitsch, MD, FACS, a Dallas surgeon, co-principal investigator of the American Society of Breast Surgeons MammoSite Registry and co-author on 12 APBI papers.

"This retrospective study of an inherently inaccurate database, which has questionable outcomes and unvalidated 'surrogate endpoints,' should be looked at with appropriate skepticism, in the face of 20 years of retrospective studies and two prospective randomized trials to the contrary," said Dr. Beitsch.

Jayant Vaidya, MD, a leading British researcher of a form of APBI called intraoperative radiotherapy (IORT), noted that along with other APBI modalities, IORT studies have so far shown the therapy to be equivalent to whole breast irradiation.

Among APBI patients troubled by reports of the MD Anderson study was Southern California resident Marion Brown, 80.

When she saw a TV news report on the study, she said, "My first thought was, 'My God, am I going to have to go through five weeks of daily radiation?' I had a bad couple of hours until I was able to speak to my surgeon."

Brown was told by Dr. Deanna Attai, her surgeon, that APBI is supported by strong clinical evidence: "She assured me that the news I saw did not reflect the results of the published clinical research."

The three major medical societies involved in the research and use of APBI have also issued statements of concern about the study conclusions. The organizations are the American Society of Breast Surgeons , the American Brachytherapy Society, and the American Society for Radiation Oncology.

Source MD Anderson Cancer Center