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

Based on the relatively short follow-up time (median 2.4 years) of this study and some missing information in the results to evaluate the non-inferiority of Intrabeam® to EBRT, the TAU policy committee did not recommend use of this technology in 2012 and 2015, except in the context of a research study. [...] Some of the hypothesized advantages of using Intrabeam® over whole breast EBRT were that IORT would: avoid unnecessary irradiation of vital organs such as the heart and lungs; reduce the frequency of patient hospital visits; shorten the waiting time for radiotherapy patients; and lower the workload of the Radiation Oncology Department. [...] The TARGIT-A trial defined their non-inferiority margin as an absolute difference of 2.5% in the binomial proportions (number of recurrences/number of patients) of the 5-year local recurrence rate between the two radiotherapy treatment groups. [...] The 95% CI calculated by the authors of the TAU report for the difference in K-M recurrence rates (cumulative incidence rates) found that the upper CI exceeded the 2.5% non- inferiority margin. [...] However, for the difference in binomial proportions (number of recurrences divided by the number of patients), the 90% CI reported in the study were within the 2.5% non-inferiority margin (Table 1).