IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational study

Introduction: Treatment of early-stage, low-risk breast cancer (BC) has undergone significant de-escalation during the past years. The TARGIT-A trial provided information on intraoperative radiotherapy (IORT) as a convenient, single-fraction modality. Nevertheless, significant discussion regarding d...

Full description

Saved in:
Bibliographic Details
Main Authors: Amalia Palacios-Eito, María del Carmen Moreno-Manzanaro, María Espinosa-Calvo, Fátima Ginés-Santiago, Juan Adrián Camús-Martínez, Ángel Calvo-Tudela, Pilar Rioja-Torres, Sara Romero-Martín, José Antonio Miñano-Herrero, Gustavo R. Sarria, Sonia García-Cabezas
Format: Article
Language:English
Published: Elsevier 2025-09-01
Series:Clinical and Translational Radiation Oncology
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2405630825000904
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849243041957675008
author Amalia Palacios-Eito
María del Carmen Moreno-Manzanaro
María Espinosa-Calvo
Fátima Ginés-Santiago
Juan Adrián Camús-Martínez
Ángel Calvo-Tudela
Pilar Rioja-Torres
Sara Romero-Martín
José Antonio Miñano-Herrero
Gustavo R. Sarria
Sonia García-Cabezas
author_facet Amalia Palacios-Eito
María del Carmen Moreno-Manzanaro
María Espinosa-Calvo
Fátima Ginés-Santiago
Juan Adrián Camús-Martínez
Ángel Calvo-Tudela
Pilar Rioja-Torres
Sara Romero-Martín
José Antonio Miñano-Herrero
Gustavo R. Sarria
Sonia García-Cabezas
author_sort Amalia Palacios-Eito
collection DOAJ
description Introduction: Treatment of early-stage, low-risk breast cancer (BC) has undergone significant de-escalation during the past years. The TARGIT-A trial provided information on intraoperative radiotherapy (IORT) as a convenient, single-fraction modality. Nevertheless, significant discussion regarding different aspects of the trial continues. This study reports on oncological outcomes in a real-world clinical setting and contributes to the understanding of its optimal indication. Methods: Five-hundred patients planned for breast-conserving surgery (BCS) were screened for IORT between June 2017 and December 2023, within this prospective, observational, single-center. The treatment protocol replicated the experimental arm of the TARGIT-A trial, implementing stricter inclusion criteria and maintaining a risk-adapted approach. The primary endpoint was ipsilateral breast recurrence rates (IBR). Secondary endpoints included local recurrence-free survival, progression-free survival, overall survival, and patient-reported cosmesis. The Kaplan-Meier method was used to analyze survival and recurrence risk, and risk factors for IBR were assessed through Cox regression analysis. Results: After screening and recruiting, IORT was performed in 464 patients. The median follow-up was 45.3 (8–89) months. The estimated 5-year IBR risk in the entire cohort was 1.7 % (95 % CI: 0.7 %–2.8 %), decreasing to 1 % (95 % CI: 0.3 %–2.4 %) in the IORT + whole breast irradiation (WBI) cohort. In the IORT-only cohort, the risk was 2.1 % (95 % CI: 0.6 %–3.7 %). No significant differences were observed among the three subgroups. The 5-year overall survival and breast cancer-specific survival rates were 97.6 % (95 % CI: 96.0 %–99.1 %) and 99.5 % (95 % CI: 98.5 %–100 %), respectively. Two independent significant risk factors for IBR were identified: age < 50 years (HR = 0.138, 95 % CI: 0.032–0.597, p = 0.008) and close or affected surgical margins (HR = 5.8, 95 % CI: 1.5–22.5, p = 0.011). No grade 3–4 toxicity events were reported. Patient-reported cosmesis was excellent/good in 84 % of cases. Conclusions: Local recurrence rates were low amongst all groups. Superior control outcomes could be obtained by applying more restrictive criteria than the TARGIT A trial. Longer follow-up is needed to confirm our findings.
format Article
id doaj-art-ccbdc87adc2e4eaf9e2355eed88297a9
institution Kabale University
issn 2405-6308
language English
publishDate 2025-09-01
publisher Elsevier
record_format Article
series Clinical and Translational Radiation Oncology
spelling doaj-art-ccbdc87adc2e4eaf9e2355eed88297a92025-08-20T03:59:37ZengElsevierClinical and Translational Radiation Oncology2405-63082025-09-015410099810.1016/j.ctro.2025.100998IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational studyAmalia Palacios-Eito0María del Carmen Moreno-Manzanaro1María Espinosa-Calvo2Fátima Ginés-Santiago3Juan Adrián Camús-Martínez4Ángel Calvo-Tudela5Pilar Rioja-Torres6Sara Romero-Martín7José Antonio Miñano-Herrero8Gustavo R. Sarria9Sonia García-Cabezas10Department of Radiation Oncology, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainDepartment of Radiation Oncology, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainDepartment of Radiation Oncology, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainDepartment of Radiation Oncology, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainDepartment of Radiation Oncology, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainDepartment of Radiation Oncology, Virgen de la Victoria University Hospital. Campus de Teatinos s/n 29010, Málaga, SpainBreast Surgery Unit, General and Digestive Surgery Department, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainBreast Cancer Unit, Department of Diagnostic Radiology, Reina Sofía University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainDepartment of Medical Physics, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainDepartment of Radiation Oncology, University Hospital Bonn, Venusberg Campus 1, 53127 Bonn, Germany; Corresponding author at: Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Bonn, Germany.Department of Radiation Oncology, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, SpainIntroduction: Treatment of early-stage, low-risk breast cancer (BC) has undergone significant de-escalation during the past years. The TARGIT-A trial provided information on intraoperative radiotherapy (IORT) as a convenient, single-fraction modality. Nevertheless, significant discussion regarding different aspects of the trial continues. This study reports on oncological outcomes in a real-world clinical setting and contributes to the understanding of its optimal indication. Methods: Five-hundred patients planned for breast-conserving surgery (BCS) were screened for IORT between June 2017 and December 2023, within this prospective, observational, single-center. The treatment protocol replicated the experimental arm of the TARGIT-A trial, implementing stricter inclusion criteria and maintaining a risk-adapted approach. The primary endpoint was ipsilateral breast recurrence rates (IBR). Secondary endpoints included local recurrence-free survival, progression-free survival, overall survival, and patient-reported cosmesis. The Kaplan-Meier method was used to analyze survival and recurrence risk, and risk factors for IBR were assessed through Cox regression analysis. Results: After screening and recruiting, IORT was performed in 464 patients. The median follow-up was 45.3 (8–89) months. The estimated 5-year IBR risk in the entire cohort was 1.7 % (95 % CI: 0.7 %–2.8 %), decreasing to 1 % (95 % CI: 0.3 %–2.4 %) in the IORT + whole breast irradiation (WBI) cohort. In the IORT-only cohort, the risk was 2.1 % (95 % CI: 0.6 %–3.7 %). No significant differences were observed among the three subgroups. The 5-year overall survival and breast cancer-specific survival rates were 97.6 % (95 % CI: 96.0 %–99.1 %) and 99.5 % (95 % CI: 98.5 %–100 %), respectively. Two independent significant risk factors for IBR were identified: age < 50 years (HR = 0.138, 95 % CI: 0.032–0.597, p = 0.008) and close or affected surgical margins (HR = 5.8, 95 % CI: 1.5–22.5, p = 0.011). No grade 3–4 toxicity events were reported. Patient-reported cosmesis was excellent/good in 84 % of cases. Conclusions: Local recurrence rates were low amongst all groups. Superior control outcomes could be obtained by applying more restrictive criteria than the TARGIT A trial. Longer follow-up is needed to confirm our findings.http://www.sciencedirect.com/science/article/pii/S2405630825000904Intraoperative radiotherapyEarly-stage breast cancerAccelerated partial breast irradiationReal world
spellingShingle Amalia Palacios-Eito
María del Carmen Moreno-Manzanaro
María Espinosa-Calvo
Fátima Ginés-Santiago
Juan Adrián Camús-Martínez
Ángel Calvo-Tudela
Pilar Rioja-Torres
Sara Romero-Martín
José Antonio Miñano-Herrero
Gustavo R. Sarria
Sonia García-Cabezas
IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational study
Clinical and Translational Radiation Oncology
Intraoperative radiotherapy
Early-stage breast cancer
Accelerated partial breast irradiation
Real world
title IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational study
title_full IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational study
title_fullStr IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational study
title_full_unstemmed IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational study
title_short IORT for early-stage, low-risk breast cancer: Outcomes from a prospective, observational study
title_sort iort for early stage low risk breast cancer outcomes from a prospective observational study
topic Intraoperative radiotherapy
Early-stage breast cancer
Accelerated partial breast irradiation
Real world
url http://www.sciencedirect.com/science/article/pii/S2405630825000904
work_keys_str_mv AT amaliapalacioseito iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT mariadelcarmenmorenomanzanaro iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT mariaespinosacalvo iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT fatimaginessantiago iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT juanadriancamusmartinez iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT angelcalvotudela iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT pilarriojatorres iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT sararomeromartin iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT joseantoniominanoherrero iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT gustavorsarria iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy
AT soniagarciacabezas iortforearlystagelowriskbreastcanceroutcomesfromaprospectiveobservationalstudy