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...
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Elsevier
2025-09-01
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| Series: | Clinical and Translational Radiation Oncology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405630825000904 |
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| 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 |
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| 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 |
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