In Reply We thank Shah et al, Bentzen et al, and Fastner et al for their comments on our randomized clinical trial of delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT).1 We address their points here.
Our conclusion makes it clear that “the preferred timing of using TARGIT-IORT is immediately—during the initial surgical excision of breast cancer.”1 The straw man argument from Bentzen et al claims, however, that they have uncovered something new, whereas we simply reiterate our strong preference, whenever possible, for the use of TARGIT-IORT concurrent with lumpectomy.2 It is noninferior in local control and reduces non–breast cancer mortality.2,3 Their calculation of P values for the presence of a difference is misleading. A noninferiority trial assumes that there will be a small difference and asks whether the observed difference is less than the noninferiority margin—which is both prespecified and clinically meaningful. This design is especially appropriate in the context of better patient-oriented outcomes—far fewer hospital visits,4 lower toxic effects, and better quality of life and cosmetic outcome.5 They ignore that the local recurrence rate after delayed TARGIT-IORT with complete 5-year follow-up was lower (3.96%) than previously estimated in 2014 (5.40%), with a smaller difference—2.91% vs 3.71%.2,3 These patients had no reduction or compromise in mastectomy-free survival, even in the long term (median, 9 years), which is crucial for patients yet totally disregarded by Bentzen et al.
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Vaidya JS, Bulsara M, Baum M. Targeted Intraoperative Radiotherapy for Early Breast Cancer—Reply. JAMA Oncol. 2020;6(10):1637–1638. doi:10.1001/jamaoncol.2020.2730
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