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

Sperk, Elena and Lemanski, Claire and Neumaier, Christian and Lauer, Juliane and Siefert, Victor and Volker, Ragna and Lindner, Christoph and Niehoff, Peter and Tallet, Agnes Richard and Racadot, Severine and Petit, Adeline and Pazos, Montserrat and Le-Blanc Onfroy, Magali and Martin, Etienne and Reuter, Christiane and Hermann, Robert Michael and Pohl, Fabian and Friedrichs, Kay and Wurschmidt, Florian and Pigorsch, Steffi and Kolberg, Hans-Christian and Graf, Heiko and Brunner, Thomas B. and Malter, Wolfram and Park-Simon, Tjoung-Wong and Brucker, Cosima and Fleckenstein, Jochen and Petersen, Cordula and Tuschy, Benjamin and Wilken, Eva Ekas and Buttner, Sylvia and Sutterlin, Marc and Flyger, Henrik and Wenz, Frederik (2025) Intraoperative radiotherapy in elderly patients with breast cancer: long-term follow-up results of the prospective phase II trial TARGIT-E. BMC CANCER, 25 (1): 1862. ISSN , 1471-2407

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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).

Item Type: Article
Uncontrolled Keywords: LUMPECTOMY PLUS TAMOXIFEN; CONSERVING SURGERY; RADIATION-THERAPY; IRRADIATION; WOMEN; OLDER; RECURRENCE; AGE; MULTICENTRICITY; Breast cancer; Accelerated partial breast irradiation (APBI); Intraoperative radiotherapy (IORT); Breast-conserving surgery; Toxicity; Cosmetic outcome; Elderly patients; TARGIT
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Strahlentherapie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 23 Mar 2026 11:16
Last Modified: 23 Mar 2026 11:16
URI: https://pred.uni-regensburg.de/id/eprint/68103

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