Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial
Open accessAbstract
Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy.Methods Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2.5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00983684.Findings 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1.20% (95% CI 0.53-2.71) in the targeted intraoperative radiotherapy and 0.95% (0.39-2.31) in the external beam radiotherapy group (difference between groups 0.25%, -1.04 to 1.54; p=0.41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3.3%] of 1113 vs external beam radiotherapy, 44 [3.9%] of 1119; p=0.44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0.5%]) than in the external beam radiotherapy group (23 patients [2.1%]; p=0.002).Interpretation For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks.Funding University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF).
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Primary endocrine therapy for older patients with early-stage ER-positive, HER2-negative breast cancer is supported by evidence showing no positive impact of surgery on overall survival.
“For example, the use of primary endocrine therapy for older patients with early-stage ER-positive, HER2-negative breast cancer is supported by evidence demonstrating no positive impact of surgery on overall survival (OS) [[48], [49], [50]].”
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- Authors
- Vaidya, J. S., Joseph, D. J., Tobias, J. S., Bulsara, M., Wenz, F., Saunders, C., Alvarado, M., Flyger, H. L., Massarut, S., Eiermann, W., Keshtgar, M., Dewar, J., Kraus-Tiefenbacher, U., Sütterlin, M., Esserman, L., Holtveg, H. M., Roncadin, M., Pigorsch, S., Metaxas, M., Falzon, M., Matthews, A., Corica, T., Williams, N. R., & Baum, M.
- Affiliations
- University College London (GB)
- Sir Charles Gairdner Hospital (AU)
- University College Hospital (GB)
- The University of Notre Dame Australia (AU)
- Heidelberg University (DE)
- The University of Western Australia (AU)
- University of California, San Francisco (US)
- University of Copenhagen (DK)
- Centro di Riferimento Oncologico (IT)
- The Royal Free Hospital (GB)
- Ninewells Hospital (GB)
- Technical University of Munich (DE)
- University College London Hospitals NHS Foundation Trust (GB)
- National Cancer Research Institute (GB)
- Corresponding author
- Vaidya, Jayant S
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2010-07
- Volume
- 376
- Issue
- 9735
- Pages
- 91-102
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2133494786
- Cited by
- 772
- References
- 62
- Citations by year
- 2026: 11 · 2025: 23 · 2024: 25 · 2023: 27 · 2022: 26 · 2021: 36 · 2020: 42 · 2019: 35 · 2018: 41 · 2017: 31 · 2016: 54 · 2015: 60 · 2014: 71 · 2013: 114 · 2012: 93
- FWCI
- 28.88
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- mediaTUM (Technical University of Munich) (submittedVersion)
- ResearchOnline@ND (The University of Notre Dame) (submittedVersion)
- Funders
- Cancer Research UK
- National Institute for Health and Care Research (07/60/49)
- University College London
- Bundesministerium für Bildung und Forschung (FKZ 01ZP0508)
- University College London Hospitals NHS Foundation Trust
- Medical Research Council
- Health Technology Assessment Programme
- National Health and Medical Research Council
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Physical Sciences › Physics and Astronomy › Radiation › Advanced Radiotherapy Techniques
- Health Sciences › Medicine › Pathology and Forensic Medicine › Breast Lesions and Carcinomas
- Keywords
- targeted intraoperative radiotherapy, whole breast irradiation, breast-conserving surgery, invasive ductal carcinoma, local recurrence, non-inferiority, INTRABEAM, adjuvant radiotherapy, TARGIT-A trial, lobular carcinoma, multicentric breast cancer, single-fraction radiotherapy, external beam radiotherapy, breast cancer treatment outcomes, intention-to-treat analysis
- MeSH terms
- Aged, Breast Neoplasms, Female, Humans, Intraoperative Care, Middle Aged, Neoplasm Recurrence, Local, Radiotherapy Dosage, Mastectomy, Segmental, Carcinoma, Ductal, Breast, Disease-Free Survival, Radiotherapy, Adjuvant
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