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Access through your institution Buy or subscribe The TARGIT-A investigators claim in their Correspondence (Vaidya, J. S. et al. Intraoperative radiotherapy for breast cancer: powerful

evidence to change practice. _Nat. Rev. Clin. Oncol_. https://doi.org/10.1038/s41571-021-00471-7 (2020))1 that our article (Sasieni, P. D. & Sawyer, E. J. Intraoperative radiotherapy for

early breast cancer — insufficient evidence to change practice. _Nat. Rev. Clin. Oncol_. 17, 723–724 (2020))2 contains several factual and logical errors but we are unclear as to what these

are. We stand by our assertion that the treatment that they recommend has not been shown to have any effect against local recurrence and suggest that, were radiotherapy held to the same

regulatory standards as chemotherapy, this particular usage would not be licensed. It seems that we failed to convey our central argument in that Vaidya et al.1 complain that we overlooked

the long-term positive findings and the patient perspective. We accept that targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) is more convenient than conventional

whole-breast external beam radiotherapy (WBRT). However, a new treatment needs to have been shown (at least indirectly) to be superior to no treatment3, and TARGIT-IORT fails in this regard.

We know of no convincing argument that TARGIT-IORT might reduce non-breast cancer mortality relative to no radiotherapy, therefore, the question as to whether TARGIT-IORT results in fewer

non-breast cancer deaths than WBRT is only relevant if TARGIT-IORT is shown to reduce breast cancer recurrence. This is a preview of subscription content, access via your institution ACCESS

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FAQs * Contact customer support REFERENCES * Vaidya, J. S. et al. Intraoperative radiotherapy for breast cancer: powerful evidence to change practice. _Nat. Rev. Clin. Oncol._

https://doi.org/10.1038/s41571-021-00471-7 (2020). * Sasieni, P. D. & Sawyer, E. J. Intraoperative radiotherapy for early breast cancer — insufficient evidence to change practice. _Nat.

Rev. Clin. Oncol._ 17, 723–724 (2020). Article  Google Scholar  * FDA. Non-Inferiority Clinical Trials to Establish Effectiveness, Guidance for Industry.

https://www.fda.gov/media/78504/download (2016). * Kunkler, I. H. et al. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME

II): a randomised controlled trial. _Lancet Oncol._ 16, 266–273 (2015). Article  Google Scholar  * Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). et al. Effect of radiotherapy

after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. _Lancet_ 378,

1707–1716 (2011). Article  Google Scholar  * Vaidya, J. S. et al. Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy

(TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial. _BMJ_ 370, m2836 (2020). Article  Google Scholar  * Murray Brunt, A. et al. Hypofractionated breast radiotherapy

for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. _Lancet_ 395, 1613–1626

(2020). Article  Google Scholar  * Vaidya, J. S. et al. Effect of delayed targeted intraoperative radiotherapy vs whole-breast radiotherapy on local recurrence and survival: long-term

results from the TARGIT-A randomized clinical trial in early breast cancer. _JAMA Oncol._ 6, e200249 (2020). Article  Google Scholar  Download references AUTHOR INFORMATION AUTHORS AND

AFFILIATIONS * School of Cancer & Pharmaceutical Sciences, King’s College London, London, UK Peter D. Sasieni & Elinor J. Sawyer Authors * Peter D. Sasieni View author publications

You can also search for this author inPubMed Google Scholar * Elinor J. Sawyer View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR

Correspondence to Peter D. Sasieni. ETHICS DECLARATIONS COMPETING INTERESTS The authors declare no competing interests. SUPPLEMENTARY INFORMATION SUPPLEMENTARY INFORMATION RIGHTS AND

PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Sasieni, P.D., Sawyer, E.J. Reply to ‘Intraoperative radiotherapy for breast cancer: powerful evidence to change

practice’. _Nat Rev Clin Oncol_ 18, 188–189 (2021). https://doi.org/10.1038/s41571-021-00472-6 Download citation * Published: 25 January 2021 * Issue Date: March 2021 * DOI:

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