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New clinical and biological insights from the international TARGIT-A randomised trial of targeted intraoperative radiotherapy during lumpectomy for breast cancer

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  • Jayant S. Vaidya
  • Max Bulsara
  • Michael Baum
  • Frederik Wenz
  • Samuele Massarut
  • Steffi Pigorsch
  • Michael Alvarado
  • Michael Douek
  • Christobel Saunders
  • Henrik Flyger
  • Wolfgang Eiermann
  • Chris Brew-Graves
  • Norman R. Williams
  • Ingrid Potyka
  • Nicholas Roberts
  • Marcelle Bernstein
  • Douglas Brown
  • Elena Sperk
  • Siobhan Laws
  • Marc Sütterlin
  • Tammy Corica
  • Steinar Lundgren
  • Dennis Holmes
  • Lorenzo Vinante
  • Fernando Bozza
  • Montserrat Pazos
  • Magali Le Blanc-Onfroy
  • Günther Gruber
  • Wojciech Polkowski
  • Konstantin J. Dedes
  • Marcus Niewald
  • Jens Blohmer
  • David McReady
  • Richard Hoefer
  • Pond Kelemen
  • Gloria Petralia
  • Mary Falzon
  • David Joseph
  • Jeffrey S. Tobias
Vis graf over relationer

Background: The TARGIT-A trial reported risk-adapted targeted intraoperative radiotherapy (TARGIT-IORT) during lumpectomy for breast cancer to be as effective as whole-breast external beam radiotherapy (EBRT). Here, we present further detailed analyses. Methods: In total, 2298 women (≥45 years, invasive ductal carcinoma ≤3.5 cm, cN0–N1) were randomised. We investigated the impact of tumour size, grade, ER, PgR, HER2 and lymph node status on local recurrence-free survival, and of local recurrence on distant relapse and mortality. We analysed the predictive factors for recommending supplemental EBRT after TARGIT-IORT as part of the risk-adapted approach, using regression modelling. Non-breast cancer mortality was compared between TARGIT-IORT plus EBRT vs. EBRT. Results: Local recurrence-free survival was no different between TARGIT-IORT and EBRT, in every tumour subgroup. Unlike in the EBRT arm, local recurrence in the TARGIT-IORT arm was not a predictor of a higher risk of distant relapse or death. Our new predictive tool for recommending supplemental EBRT after TARGIT-IORT is at Non-breast cancer mortality was significantly lower in the TARGIT-IORT arm, even when patients received supplemental EBRT, HR 0.38 (95% CI 0.17–0.88) P = 0.0091. Conclusion: TARGIT-IORT is as effective as EBRT in all subgroups. Local recurrence after TARGIT-IORT, unlike after EBRT, has a good prognosis. TARGIT-IORT might have a beneficial abscopal effect. Trial registration: ISRCTN34086741 (21/7/2004), NCT00983684 (24/9/2009).

TidsskriftBritish Journal of Cancer
Udgave nummer3
Sider (fra-til)380-389
Antal sider10
StatusUdgivet - 3 aug. 2021

Bibliografisk note

Funding Information:
Competing interests J.S.V. has received a research grant from Photoelectron Corp (1996–99) and from Carl Zeiss for supporting data management at the University of Dundee (Dundee, UK, 2004-2008) and has received honoraria. J.S.V., J.S.T., N.W., I.P., C. B.-G. and N.R. receive funding from HTA, NIHR, Department of Health for some activities related to the TARGIT trials. M.Ba. was briefly on the scientific advisory board of Carl Zeiss and was paid consultancy fees before 2010. F.W. has received a research grant from Carl Zeiss for supporting radiobiological research. Carl Zeiss sponsors some of the travel and accommodation for meetings of the international steering committee and data monitoring committee and when necessary for conferences where a presentation about targeted intraoperative radiotherapy is being made for all authors apart from WE who declares that he has no conflicts of interest. The remaining authors declare no competing interests.

Funding Information:
Funding information The study was sponsored by University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre. Funding was provided by UCLH Charities, National Institute for Health Research (NIHR) Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF) FKZ 01ZP0508. The infrastructure of the trial operations office in London, UK, was supported by core funding from Cancer Research Campaign (now Cancer Research UK) when the trial was initiated. The funding organisations had no role in the concept, design, analysis or writing of the manuscript.

Publisher Copyright:
© 2021, The Author(s).

Copyright 2021 Elsevier B.V., All rights reserved.

ID: 66209005