Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial

Yasmin A. Civil; Jeanine E. Vasmel; Ramona K. Charaghvandi; Anette C. Houweling; Celien P.H. Vreuls; Paul J. van Diest; Arjen J. Witkamp; Annemiek Doeksen; Thijs van Dalen; Joeke Felderhof; Iris van Dam; Ben J. Slotman; Anna M. Kirby; Helena M. Verkooijen; Susanne van der Velde; Femke van der Leij; H. J.G.Desirée van den Bongard

doi:10.1016/j.ijrobp.2024.07.2326

Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial

Yasmin A. Civil^*
, Jeanine E. Vasmel
, Ramona K. Charaghvandi
, Anette C. Houweling
, Celien P.H. Vreuls
, Paul J. van Diest
, Arjen J. Witkamp
, Annemiek Doeksen
, Thijs van Dalen
, Joeke Felderhof
, Iris van Dam
, Ben J. Slotman
, Anna M. Kirby
, Helena M. Verkooijen
, Susanne van der Velde
, Femke van der Leij
, H. J.G.Desirée van den Bongard

^*Corresponding author for this work

Surgery

Vrije Universiteit Amsterdam
Amsterdam UMC
Utrecht University
Radboud University Medical Center
St. Antonius Ziekenhuis
Royal Marsden NHS Foundation Trust

Research output: Contribution to journal › Article › Academic › peer-review

13 Citations (Scopus)

67 Downloads (Pure)

Abstract

Purpose

Preoperative partial breast irradiation (PBI) can increase accuracy of target volume definition and decrease irradiated volumes compared with postoperative PBI. In the ABLATIVE trial (NCT02316561), 15 of 36 patients achieved pathologic complete response 6 to 8 months after preoperative PBI and breast-conserving surgery (BCS). We now present the 5-year results.

Methods and Materials

The ABLATIVE trial is a Dutch prospective cohort study conducted in 4 hospitals. Women aged ≥50 years with unifocal, nonlobular breast cancer, estrogen receptor-positive, HER2-negative, and a tumor negative sentinel node were treated between 2015 and 2018 with preoperative single-dose PBI followed by BCS after 6 or 8 months. The primary endpoint was pathologic complete response. Secondary endpoints were annually evaluated oncological outcomes, toxicity, cosmetic outcome (assessed by patients and physicians), and quality of life.

Results

Thirty-six patients were treated with BCS 6 (n = 15) and 8 (n = 21) months following PBI. Median tumor size was 13 mm (IQR 9-16 mm). After a median follow-up of 5.5 years (IQR, 5.1-6.0), 2 (6%) patients had ipsilateral breast events and 2 (6%) distant metastases. The 5-year overall survival was 94% (95% CI, 87-100). The 5-year cumulative incidence of clinician-reported grade 1/2 breast fibrosis and breast discomfort/pain were 94%/6% and 75%/6%, respectively. The proportion of patients (very) satisfied with the cosmetic results was 89% at baseline and 78% at 5 years. Cosmetic results evaluated using the BCCT.core software were excellent or good in all patients. The 4-year median global quality of life score was 83 (IQR, 67-92), similar to baseline (83; IQR, 75-83; P = .42).

Conclusions

Preoperative single-dose PBI and BCS may be an oncologically safe treatment with mild late toxicity and no decline in cosmetic results and quality of life during 5 years of follow-up. This means that preoperative instead of standard postoperative irradiation has the potential to challenge the current clinical practice.

Original language	English
Pages (from-to)	613-622
Number of pages	10
Journal	International Journal of Radiation Oncology Biology Physics
Volume	121
Issue number	3
DOIs	https://doi.org/10.1016/j.ijrobp.2024.07.2326
Publication status	Published - 1 Mar 2025

Bibliographical note

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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1-s2.0-S036030162403147X-mainFinal published version, 1.2 MBLicence: CC BY

Cite this

Civil, Y. A., Vasmel, J. E., Charaghvandi, R. K., Houweling, A. C., Vreuls, C. P. H., van Diest, P. J., Witkamp, A. J., Doeksen, A., van Dalen, T., Felderhof, J., van Dam, I., Slotman, B. J., Kirby, A. M., Verkooijen, H. M., van der Velde, S., van der Leij, F., & van den Bongard, H. J. G. D. (2025). Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial. International Journal of Radiation Oncology Biology Physics, 121(3), 613-622. https://doi.org/10.1016/j.ijrobp.2024.07.2326

@article{1a21f7da07eb4e8796ec44c1479519bf,

title = "Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial",

abstract = "PurposePreoperative partial breast irradiation (PBI) can increase accuracy of target volume definition and decrease irradiated volumes compared with postoperative PBI. In the ABLATIVE trial (NCT02316561), 15 of 36 patients achieved pathologic complete response 6 to 8 months after preoperative PBI and breast-conserving surgery (BCS). We now present the 5-year results.Methods and MaterialsThe ABLATIVE trial is a Dutch prospective cohort study conducted in 4 hospitals. Women aged ≥50 years with unifocal, nonlobular breast cancer, estrogen receptor-positive, HER2-negative, and a tumor negative sentinel node were treated between 2015 and 2018 with preoperative single-dose PBI followed by BCS after 6 or 8 months. The primary endpoint was pathologic complete response. Secondary endpoints were annually evaluated oncological outcomes, toxicity, cosmetic outcome (assessed by patients and physicians), and quality of life.ResultsThirty-six patients were treated with BCS 6 (n = 15) and 8 (n = 21) months following PBI. Median tumor size was 13 mm (IQR 9-16 mm). After a median follow-up of 5.5 years (IQR, 5.1-6.0), 2 (6\%) patients had ipsilateral breast events and 2 (6\%) distant metastases. The 5-year overall survival was 94\% (95\% CI, 87-100). The 5-year cumulative incidence of clinician-reported grade 1/2 breast fibrosis and breast discomfort/pain were 94\%/6\% and 75\%/6\%, respectively. The proportion of patients (very) satisfied with the cosmetic results was 89\% at baseline and 78\% at 5 years. Cosmetic results evaluated using the BCCT.core software were excellent or good in all patients. The 4-year median global quality of life score was 83 (IQR, 67-92), similar to baseline (83; IQR, 75-83; P = .42).ConclusionsPreoperative single-dose PBI and BCS may be an oncologically safe treatment with mild late toxicity and no decline in cosmetic results and quality of life during 5 years of follow-up. This means that preoperative instead of standard postoperative irradiation has the potential to challenge the current clinical practice.",

author = "Civil, \{Yasmin A.\} and Vasmel, \{Jeanine E.\} and Charaghvandi, \{Ramona K.\} and Houweling, \{Anette C.\} and Vreuls, \{Celien P.H.\} and \{van Diest\}, \{Paul J.\} and Witkamp, \{Arjen J.\} and Annemiek Doeksen and \{van Dalen\}, Thijs and Joeke Felderhof and \{van Dam\}, Iris and Slotman, \{Ben J.\} and Kirby, \{Anna M.\} and Verkooijen, \{Helena M.\} and \{van der Velde\}, Susanne and \{van der Leij\}, Femke and \{van den Bongard\}, \{H. J.G.Desir{\'e}e\}",

note = "{\textcopyright} 2024 The Author(s)",

year = "2025",

month = mar,

day = "1",

doi = "10.1016/j.ijrobp.2024.07.2326",

language = "English",

volume = "121",

pages = "613--622",

journal = "International Journal of Radiation Oncology Biology Physics",

issn = "0360-3016",

publisher = "Elsevier Inc.",

number = "3",

}

Civil, YA, Vasmel, JE, Charaghvandi, RK, Houweling, AC, Vreuls, CPH, van Diest, PJ, Witkamp, AJ, Doeksen, A, van Dalen, T, Felderhof, J, van Dam, I, Slotman, BJ, Kirby, AM, Verkooijen, HM, van der Velde, S, van der Leij, F & van den Bongard, HJGD 2025, 'Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial', International Journal of Radiation Oncology Biology Physics, vol. 121, no. 3, pp. 613-622. https://doi.org/10.1016/j.ijrobp.2024.07.2326

Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial. / Civil, Yasmin A.; Vasmel, Jeanine E.; Charaghvandi, Ramona K. et al.
In: International Journal of Radiation Oncology Biology Physics, Vol. 121, No. 3, 01.03.2025, p. 613-622.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation

T2 - 5-Year Results of the Prospective Single-Arm ABLATIVE Trial

AU - Civil, Yasmin A.

AU - Vasmel, Jeanine E.

AU - Charaghvandi, Ramona K.

AU - Houweling, Anette C.

AU - Vreuls, Celien P.H.

AU - van Diest, Paul J.

AU - Witkamp, Arjen J.

AU - Doeksen, Annemiek

AU - van Dalen, Thijs

AU - Felderhof, Joeke

AU - van Dam, Iris

AU - Slotman, Ben J.

AU - Kirby, Anna M.

AU - Verkooijen, Helena M.

AU - van der Velde, Susanne

AU - van der Leij, Femke

AU - van den Bongard, H. J.G.Desirée

PY - 2025/3/1

Y1 - 2025/3/1

N2 - PurposePreoperative partial breast irradiation (PBI) can increase accuracy of target volume definition and decrease irradiated volumes compared with postoperative PBI. In the ABLATIVE trial (NCT02316561), 15 of 36 patients achieved pathologic complete response 6 to 8 months after preoperative PBI and breast-conserving surgery (BCS). We now present the 5-year results.Methods and MaterialsThe ABLATIVE trial is a Dutch prospective cohort study conducted in 4 hospitals. Women aged ≥50 years with unifocal, nonlobular breast cancer, estrogen receptor-positive, HER2-negative, and a tumor negative sentinel node were treated between 2015 and 2018 with preoperative single-dose PBI followed by BCS after 6 or 8 months. The primary endpoint was pathologic complete response. Secondary endpoints were annually evaluated oncological outcomes, toxicity, cosmetic outcome (assessed by patients and physicians), and quality of life.ResultsThirty-six patients were treated with BCS 6 (n = 15) and 8 (n = 21) months following PBI. Median tumor size was 13 mm (IQR 9-16 mm). After a median follow-up of 5.5 years (IQR, 5.1-6.0), 2 (6%) patients had ipsilateral breast events and 2 (6%) distant metastases. The 5-year overall survival was 94% (95% CI, 87-100). The 5-year cumulative incidence of clinician-reported grade 1/2 breast fibrosis and breast discomfort/pain were 94%/6% and 75%/6%, respectively. The proportion of patients (very) satisfied with the cosmetic results was 89% at baseline and 78% at 5 years. Cosmetic results evaluated using the BCCT.core software were excellent or good in all patients. The 4-year median global quality of life score was 83 (IQR, 67-92), similar to baseline (83; IQR, 75-83; P = .42).ConclusionsPreoperative single-dose PBI and BCS may be an oncologically safe treatment with mild late toxicity and no decline in cosmetic results and quality of life during 5 years of follow-up. This means that preoperative instead of standard postoperative irradiation has the potential to challenge the current clinical practice.

AB - PurposePreoperative partial breast irradiation (PBI) can increase accuracy of target volume definition and decrease irradiated volumes compared with postoperative PBI. In the ABLATIVE trial (NCT02316561), 15 of 36 patients achieved pathologic complete response 6 to 8 months after preoperative PBI and breast-conserving surgery (BCS). We now present the 5-year results.Methods and MaterialsThe ABLATIVE trial is a Dutch prospective cohort study conducted in 4 hospitals. Women aged ≥50 years with unifocal, nonlobular breast cancer, estrogen receptor-positive, HER2-negative, and a tumor negative sentinel node were treated between 2015 and 2018 with preoperative single-dose PBI followed by BCS after 6 or 8 months. The primary endpoint was pathologic complete response. Secondary endpoints were annually evaluated oncological outcomes, toxicity, cosmetic outcome (assessed by patients and physicians), and quality of life.ResultsThirty-six patients were treated with BCS 6 (n = 15) and 8 (n = 21) months following PBI. Median tumor size was 13 mm (IQR 9-16 mm). After a median follow-up of 5.5 years (IQR, 5.1-6.0), 2 (6%) patients had ipsilateral breast events and 2 (6%) distant metastases. The 5-year overall survival was 94% (95% CI, 87-100). The 5-year cumulative incidence of clinician-reported grade 1/2 breast fibrosis and breast discomfort/pain were 94%/6% and 75%/6%, respectively. The proportion of patients (very) satisfied with the cosmetic results was 89% at baseline and 78% at 5 years. Cosmetic results evaluated using the BCCT.core software were excellent or good in all patients. The 4-year median global quality of life score was 83 (IQR, 67-92), similar to baseline (83; IQR, 75-83; P = .42).ConclusionsPreoperative single-dose PBI and BCS may be an oncologically safe treatment with mild late toxicity and no decline in cosmetic results and quality of life during 5 years of follow-up. This means that preoperative instead of standard postoperative irradiation has the potential to challenge the current clinical practice.

UR - https://www.scopus.com/pages/publications/85201509329

U2 - 10.1016/j.ijrobp.2024.07.2326

DO - 10.1016/j.ijrobp.2024.07.2326

M3 - Article

C2 - 39098432

AN - SCOPUS:85201509329

SN - 0360-3016

VL - 121

SP - 613

EP - 622

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

IS - 3

ER -

Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial

Abstract

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