TY - JOUR
T1 - Balloon brachytherapy for breast cancer prove that it works? Or, prove that it doesn't?
AU - Prasad, Vinay
N1 - Funding Information:
V. Prasad (*) Medical Oncology Branch, National Cancer Institute, National Institutes of Health, 10 Center Dr. 10/12N226, Bethesda, MD 20892, usa e-mail: vinayak.prasad@nih.gov
PY - 2014/8
Y1 - 2014/8
N2 - Balloon breast brachytherapy is a catheter-based technique to deliver high local concentration of radiation following breast-sparing surgery. Although this technique is logically appealing - providing more directed radiation to sites at high risk of local failure - there remains little empirical support that this intervention is non-inferior to external beam radiotherapy, a well-established standard. Additionally, observational studies suggest that balloon brachytherapy is associated with high rates of local complications, and higher rates of subsequent mastectomy, a marker of local failure. Here, I explore regulatory and clinical considerations that lead to the widespread adoption of breast brachytherapy. I argue that the therapy spread before its efficacy was confirmed. Breast brachytherapy illustrates ongoing complexities in the approval of novel devices.
AB - Balloon breast brachytherapy is a catheter-based technique to deliver high local concentration of radiation following breast-sparing surgery. Although this technique is logically appealing - providing more directed radiation to sites at high risk of local failure - there remains little empirical support that this intervention is non-inferior to external beam radiotherapy, a well-established standard. Additionally, observational studies suggest that balloon brachytherapy is associated with high rates of local complications, and higher rates of subsequent mastectomy, a marker of local failure. Here, I explore regulatory and clinical considerations that lead to the widespread adoption of breast brachytherapy. I argue that the therapy spread before its efficacy was confirmed. Breast brachytherapy illustrates ongoing complexities in the approval of novel devices.
KW - Balloon brachytherapy
KW - Evidence-based medicine
KW - Mammosite
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U2 - 10.1007/s00432-014-1705-4
DO - 10.1007/s00432-014-1705-4
M3 - Review article
C2 - 24858568
AN - SCOPUS:84904370152
SN - 0171-5216
VL - 140
SP - 1353
EP - 1357
JO - Journal of Cancer Research and Clinical Oncology
JF - Journal of Cancer Research and Clinical Oncology
IS - 8
ER -