Evidence map›Paper›PMID 41345599›Full record

Trial reportBMC cancer2025

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

Elena Sperk, Claire Lemanski, Christian Neumaier, Juliane Lauer, Victor Siefert, Ragna Völker, Christoph Lindner, Peter Niehoff, Agnes Richard Tallet, Séverine Racadot and 24 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01299987 (TARGIT-E), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01299987 nacompletednot on this map

TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer

TypeinterventionalSponsorUniversitätsmedizin MannheimRan2011 to 2022Enrolled591ConditionsBreast Neoplasms, Breast Diseases, Neoplasm Recurrence, Local, NeoplasmsArmsintraoperative radiotherapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Elena SperkDepartment of Radiation Oncology, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. Elena.Sperk@medma.uni-heidelberg.de.
Claire LemanskiInstitut 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.
Christian NeumaierDepartment of Radiation Oncology, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Juliane LauerDepartment of Radiation Oncology, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Victor SiefertDepartment of Radiation Oncology, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Ragna VölkerBrustzentrum City, Alexianer St.-Gertrauden Krankenhaus, Paretzer Str. 12, 10713, Berlin, Germany.
Christoph LindnerAgaplesion Diakonieklinikum Hamburg, Hohe Weide 17, 20259, Hamburg, Germany.
Peter NiehoffDepartment of Radiation Oncology, Kliniken Köln, Universität Witten/Herdecke, 51067, Neufelder Str. 34Köln, Germany.
Agnes Richard TalletRadiotherapy Department, Insitut Paoli Calmettes, 232 Boulevard de Sainte-Marguerite, 13009, Marseille, France.
Séverine RacadotRadiotherapy Department, Centre Léon Bérard, 28 Rue Laënnec, 69008, Lyon, France.
Adeline PetitDepartment of Radiation Oncology, Institut Bergonié, 229 Cr de l'Argonne, 33076, Bordeaux, France.
Montserrat PazosLMU Klinikum, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Campus Innenstadt, Ziemssenstr. 1 80, 336, München, Germany.
Magali Le-Blanc OnfroyInstitut de Cancérologie de l'Ouest (ICO), Boulevard Jacques Monod, 44805, Saint Herblain, France.
Etienne MartinGeorges-François Leclerc Center, Department of Radiotherapy, 1 Rue du Pr Marion, BP77980, 21079, Dijon, France.
Christiane ReuterRadiologie Plus, Kantonsspital Frauenfeld, Pfaffenholzstrasse 4, 8501, Frauenfeld, Switzerland.
Robert Michael HermannCenter for Radiotherapy and Radiooncology Bremen and Westerstede, An der Hössen 34, 26655, Westerstede, Germany.
Fabian PohlDepartment for Radiotherapy, Regensburg University Hospital, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.
Kay FriedrichsMammazentrum HH am Krankenhaus Jerusalem, Moorkamp 2-6, 20357, Hamburg, Germany.
Florian WürschmidtRadiologische Allianz Hamburg, Mörkenstraße 47, Hamburg, 22767, Germany.
Steffi PigorschTechnical University of Munich, School of Medicine and Health, Department of RadioOncology and Radiotherapy, Ismaningerstrasse 22, 1675, München, Germany.
Hans-Christian KolbergDepartment of Gynecology and Obstetrics, Marienhospital Bottrop, Josef-Albers-Str. 70, 46236, Bottrop, Germany.
Heiko GrafSüdthüringer Brustzentrum am Helios Klinikum Meiningen, Bergstraße 3, 98617, Meiningen, Germany.
Thomas B BrunnerDepartment of Radiation Oncology, University Medical Center Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
Wolfram MalterUniversity 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.
Tjoung-Wong Park-SimonDepartment of Obstetrics and Gynaecology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
Cosima BruckerUniversity Women's Hospital, Paracelsus Medical University Nuremberg, Prof. Ernst Nathan-Str. 1, 90419, Nürnberg, Germany.
Jochen FleckensteinDepartment of Radiotherapy and Radiation Oncology, Saarland University Medical Center, Kirrberger Str. 100, 66421, Homburg, Germany.
Cordula PetersenDepartment of Radiotherapy and Radiation Oncology, Medical Center Hamburg-Eppendorf, Medical Faculty University of Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
Benjamin TuschyDepartment of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Eva Ekas WilkenDepartment of Oncology Herlev and Gentofte Hospital, University of Copenhagen, Borgmester Ib Juuls Vej 1, 2730, Herlev, Denmark.
Sylvia BüttnerDepartment of Medical Statistics, Biomathematics and Information Processing, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Marc SütterlinDepartment of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Henrik Flyger *Department of Breast Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 3B, 2900, Hellerup, Denmark.
Frederik Wenz *Department of Radiation Oncology, Medical Faculty Mannheim, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhole-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.

methodsPatients 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.

resultsIn 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.

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

Indexed as

Breast NeoplasmsAgedAged, 80 and overFemaleFollow-Up StudiesHumansIntraoperative CareMastectomy, SegmentalNeoplasm Recurrence, LocalProspective StudiesRadiotherapy, AdjuvantTreatment OutcomeAccelerated partial breast irradiation (APBI)Breast cancerBreast-conserving surgeryCosmetic outcomeElderly patientsIntraoperative radiotherapy (IORT)TARGITToxicity

Identifiers

PMID41345599
PMCPMC12690916

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