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Publications

Journal Article Ahead of print

PubMed: 41345599 DOI: 10.1186/s12885-025-15289-0

Intraoperative radiotherapy in elderly patients with breast cancer: long-term follow-up results of the prospective phase II trial TARGIT-E.

BMC Cancer

Authors: Elena Sperk, Claire Lemanski, Christian Neumaier, Juliane Lauer, Victor Siefert, Ragna Völker, Christoph Lindner, Peter Niehoff, Agnes Richard Tallet, Séverine Racadot, Adeline Petit, Montserrat Pazos, Magali Le-Blanc Onfroy, Etienne Martin, Christiane Reuter, Robert Michael Hermann, Fabian Pohl, Kay Friedrichs, Florian Würschmidt, Steffi Pigorsch, Hans-Christian Kolberg, Heiko Graf, Thomas B Brunner, Wolfram Malter, Tjoung-Wong Park-Simon, Cosima Brucker, Jochen Fleckenstein, Cordula Petersen, Benjamin Tuschy, Eva Ekas Wilken, Sylvia Büttner, Marc Sütterlin, Henrik Flyger, Frederik Wenz

Affiliations

  • Department of Radiation Oncology, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
  • Mannheim Cancer Center, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
  • Institut de Recherche en Cancérologie de Montpellier (U1194), Department of Radiation Oncology, Montpellier Cancer Institute (ICM), University of Montpellier - Campus Val d'Aurelle, 208 Avenue Des Apothicaires, 34298, Montpellier, France.
  • Department of Radiation Oncology, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
  • Clinical Center Worms, MVZ Strahlentherapie Worms GmbH, Gabriel-Von-Seidl-Str. 81, 67550, Worms, Germany.
  • Department of Anaesthesiology, Intensive Care Unit and Emergency Medicine, Hospital Ludwigshafen, Bremserstraße 79, 67063, Ludwigshafen, Germany.
  • Brustzentrum City, Alexianer St.-Gertrauden Krankenhaus, Paretzer Str. 12, 10713, Berlin, Germany.
  • Agaplesion Diakonieklinikum Hamburg, Hohe Weide 17, 20259, Hamburg, Germany.
  • Department of Radiation Oncology, Kliniken Köln, Universität Witten/Herdecke, 51067, Neufelder Str. 34Köln, Germany.
  • Department of Radiation Oncology, Sana Klinkum Offenbach, Starkenburgring 66, 63069, Offenbach, Germany.
  • Radiotherapy Department, Insitut Paoli Calmettes, 232 Boulevard de Sainte-Marguerite, 13009, Marseille, France.
  • Radiotherapy Department, Centre Léon Bérard, 28 Rue Laënnec, 69008, Lyon, France.
  • Department of Radiation Oncology, Institut Bergonié, 229 Cr de l'Argonne, 33076, Bordeaux, France.
  • LMU Klinikum, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Campus Innenstadt, Ziemssenstr. 1 80, 336, München, Germany.
  • Institut de Cancérologie de l'Ouest (ICO), Boulevard Jacques Monod, 44805, Saint Herblain, France.
  • Georges-François Leclerc Center, Department of Radiotherapy, 1 Rue du Pr Marion, BP77980, 21079, Dijon, France.
  • Radiologie Plus, Kantonsspital Frauenfeld, Pfaffenholzstrasse 4, 8501, Frauenfeld, Switzerland.
  • Center for Radiotherapy and Radiooncology Bremen and Westerstede, An der Hössen 34, 26655, Westerstede, Germany.
  • Department of Radiotherapy, Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
  • Department for Radiotherapy, Regensburg University Hospital, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.
  • Mammazentrum HH am Krankenhaus Jerusalem, Moorkamp 2-6, 20357, Hamburg, Germany.
  • Radiologische Allianz Hamburg, Mörkenstraße 47, Hamburg, 22767, Germany.
  • Technical University of Munich, School of Medicine and Health, Department of RadioOncology and Radiotherapy, Ismaningerstrasse 22, 1675, München, Germany.
  • Department of Gynecology and Obstetrics, Marienhospital Bottrop, Josef-Albers-Str. 70, 46236, Bottrop, Germany.
  • Südthüringer Brustzentrum am Helios Klinikum Meiningen, Bergstraße 3, 98617, Meiningen, Germany.
  • Department of Radiation Oncology, University Medical Center Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
  • Medizinische Universität Graz, Auenbruggerplatz 32, 8036, Graz, Austria.
  • University of Cologne, Medical Faculty and University Clinic of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, Department of Gynecology and Gynecologic Oncology, Kerpener Str. 62, 50937, Köln, Germany.
  • Department of Obstetrics and Gynaecology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
  • University Women's Hospital, Paracelsus Medical University Nuremberg, Prof. Ernst Nathan-Str. 1, 90419, Nürnberg, Germany.
  • Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center, Kirrberger Str. 100, 66421, Homburg, Germany.
  • Department of Radiotherapy, Westpfalz-Klinikum Kaiserslautern, Hellmut-Hartert-Str. 1, 67655, Kaiserslautern, Germany.
  • Department of Radiotherapy and Radiation Oncology, Medical Center Hamburg-Eppendorf, Medical Faculty University of Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
  • Department of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
  • Department of Oncology Herlev and Gentofte Hospital, University of Copenhagen, Borgmester Ib Juuls Vej 1, 2730, Herlev, Denmark.
  • Department of Medical Statistics, Biomathematics and Information Processing, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
  • Department of Breast Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 3B, 2900, Hellerup, Denmark.
  • Medical Faculty, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg im Breisgau, Germany.

Abstract

BACKGROUND

Whole-breast radiotherapy (WBRT) after breast-conserving surgery (BCS) in older patients can be challenging due to the increased presence of comorbidities, comedication, the presence of a pacemaker or difficulties in traveling to treatment every day. Challenging times, such as the pandemic, can also lead to RT not being performed despite the indication. Very short treatment regimens are therefor of special interest in this population reducing overall treatment time and radiation exposure. TARGIT-E is a phase II trial investigating intraoperative radiotherapy (IORT) during BCS in elderly patients. We report long-term follow-up results of TARGIT-E.

METHODS

Patients with BC (≥ 70 years, cT1-2, cN0, M0) were enrolled at 28 European centers. A single dose of IORT (20 Gy) was given during BCS. Additional postoperative WBRT was applied if risk factors were present in final histopathology. Primary outcome was local recurrence-free rate (RFR) using the Kaplan-Meier-method. Late toxicities were assessed by LENT-SOMA criteria, and cosmetic outcomes were graded using BCCT.core software.

RESULTS

In 591 patients (median follow-up 5.4 years) RFR was 97.6% (CI: 96.1, 99.2) and 97.1% (CI: 95.2, 98.9) after 5 and 7 years. Overall survival was 96.2% (CI: 94.4, 98.1) and 91.8% (CI: 91.5, 92.1) after 5 and 7 years. We observed either no or mild late toxicities after 7 years. The most frequent toxicities were fibrosis (grade II-III: 15.7%), pain (grade II-III: 3.3%), retractions (grade I: 30%), and teleangiectasia (grade I: 8.9%). Chronic higher-grade fibrosis was seen in 10% and chronic pain in 2% after 7 years in patients treated with IORT only. Cosmetic outcomes were excellent or good for most patients.

CONCLUSIONS

The high local control rate and overall survival in combination with low occurrence of late toxicities over 7 years demonstrate that targeted intraoperative radiotherapy is a fast, simple and feasible method during breast-conserving surgery for selected elderly patients.

TRIAL REGISTRATION

TARGIT E was prospectively registered at ClinicalTrials.gov with the number NCT01299987 (date: 18 February 2011).

MeSH

Radiotherapy, Breast Neoplasms, Fibrosis, Pain, Neoplasms, Aged, Breast, Therapeutics