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


Journal

British journal of cancer
ISSN: 1532-1827
Titre abrégé: Br J Cancer
Pays: England
ID NLM: 0370635

Informations de publication

Date de publication:
08 2021
Historique:
received: 09 10 2020
accepted: 13 05 2021
revised: 26 04 2021
pubmed: 27 5 2021
medline: 15 12 2021
entrez: 26 5 2021
Statut: ppublish

Résumé

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. 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. 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 https://targit.org.uk/addrt . 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. 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. ISRCTN34086741 (21/7/2004), NCT00983684 (24/9/2009).

Sections du résumé

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 https://targit.org.uk/addrt . 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).

Identifiants

pubmed: 34035435
doi: 10.1038/s41416-021-01440-8
pii: 10.1038/s41416-021-01440-8
pmc: PMC8329051
doi:

Banques de données

ClinicalTrials.gov
['NCT00983684']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

380-389

Subventions

Organisme : Department of Health
ID : 14/49/13
Pays : United Kingdom
Organisme : Department of Health
ID : 07/60/49
Pays : United Kingdom
Organisme : Department of Health
ID : 10/104/07
Pays : United Kingdom

Informations de copyright

© 2021. The Author(s).

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Auteurs

Jayant S Vaidya (JS)

Division of Surgery and Interventional Science, University College London, London, UK. jayantvaidya@gmail.com.

Max Bulsara (M)

Department of Biostatistics, University of Notre Dame, Fremantle, WA, Australia.

Michael Baum (M)

Division of Surgery and Interventional Science, University College London, London, UK.

Frederik Wenz (F)

Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Samuele Massarut (S)

Department of Surgery, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.

Steffi Pigorsch (S)

Department of Radiation Oncology, Red Cross Hospital, Technical University of Munich, Munich, Germany.

Michael Alvarado (M)

Department of Surgery, University of California, San Francisco, CA, USA.

Michael Douek (M)

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.

Christobel Saunders (C)

School of Surgery, University of Western Australia, Perth, WA, Australia.

Henrik Flyger (H)

Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.

Wolfgang Eiermann (W)

Department of Gynecology and Obstetrics, Red Cross Hospital, Technical University of Munich, Munich, Germany.

Chris Brew-Graves (C)

Division of Surgery and Interventional Science, University College London, London, UK.

Norman R Williams (NR)

Division of Surgery and Interventional Science, University College London, London, UK.

Ingrid Potyka (I)

Division of Surgery and Interventional Science, University College London, London, UK.

Nicholas Roberts (N)

Division of Surgery and Interventional Science, University College London, London, UK.

Marcelle Bernstein (M)

Patient advocate and writer, London, UK.

Douglas Brown (D)

Department of Surgery, Ninewells Hospital, Dundee, UK.

Elena Sperk (E)

Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Siobhan Laws (S)

Department of Surgery, Royal Hampshire County Hospital, Winchester, UK.

Marc Sütterlin (M)

Department of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Berlin, Germany.

Tammy Corica (T)

Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.

Steinar Lundgren (S)

Department of Oncology, St Olav's University Hospital, & Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.

Dennis Holmes (D)

John Wayne Cancer Institute & Helen Rey Breast Cancer Foundation, University of Southern California, Los Angeles, CA, USA.

Lorenzo Vinante (L)

Department of Radiation Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.

Fernando Bozza (F)

Department of Surgery, Instituto Oncologico Veneto (IVO) IRCCS, Padoa, Italy.

Montserrat Pazos (M)

Department of Radiation Oncology, University Hospital, Ludwig Maximilians Universitat, Munich, Germany.

Magali Le Blanc-Onfroy (ML)

Oncologie radiothérapeute, Institut de Cancérologie de l'Ouest, Nantes, France.

Günther Gruber (G)

Brust Zentrum Seefeld, Zurich, Switzerland.

Wojciech Polkowski (W)

Department of Surgical Oncology, Medical University of Lublin, Lublin, Poland.

Konstantin J Dedes (KJ)

Breast Center, Universitätsspital Zürich, Zurich, Switzerland.

Marcus Niewald (M)

Saarland University Medical Center, Homburg, Germany.

Jens Blohmer (J)

Sankt Gertrauden-Krankenhaus, and The Charité-Universitätsmedizin Berlin, Berlin, Germany.

David McReady (D)

Princess Margaret Cancer Centre, Toronto, Canada.

Richard Hoefer (R)

Sentara Surgery Specialists, Hampton, VA, USA.

Pond Kelemen (P)

Ashikari Breast Center, New York Medical College, New York, NY, USA.

Gloria Petralia (G)

Department of Surgery, University College London Hospitals, London, UK.

Mary Falzon (M)

Department of Pathology University College London Hospitals, London, UK.

David Joseph (D)

Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.

Jeffrey S Tobias (JS)

Department of Clinical Oncology, University College London Hospitals, London, UK.

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