Authors' objectives: The objectives of this report were to update our previous report on the efficacy and safety of the Intrabeam® intraoperative device in preventing local breast cancer recurrences when compared with external beam radiotherapy, among women with early-stage breast cancer.

Authors' recommendations: The TARGIT-A trial remains the sole trial comparing intraoperative radiation therapy using Intrabeam® to conventional external beam radiation therapy. Given the serious concerns with the results, the current evidence fails to conclusively establish the non-inferiority of Intrabeam® to external beam radiation. The short median follow-up time of 2.4 years in the TARGIT-A trial is particularly problematic if hormone receptor-positive women, who constituted the majority of trial participants, are more likely to have recurrences later in follow-up. A longer follow-up may indeed establish non-inferiority of Intrabeam®, but until such convincing evidence is available, Intrabeam® should only be considered an experimental procedure to be delivered under strict research protocols. Guidelines established by the radiation oncology societies as well as the selection criteria used in TARGIT-A may serve in selecting appropriate low-risk patients in such research settings.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.mcgill.ca/tau/files/tau/muhc_tau_2015_76_intrabeam_a.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Technology Assessment Unit of the McGill University Health Centre (MUHC)

Contact Address: Technology Assessment Unit of the MUHC, 536-5100 Boul. Maisonneuve O, Montreal, H4A 3T2

Contact Name: eva.suarthana@mcgill.ca

Contact Email: nisha.almeida@muhc.mcgill.ca

Copyright: Technology Assessment Unit of the McGill University Health Centre (MUHC)