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Preoperative stereotactic body radiotherapy for early-stage luminal breast cancer: a systematic review and meta-analysis (PRELUMEN)

In brief

Pre-op SBRT yields complete tumor disappearance in 21% of early luminal breast cancers

A meta-analysis of 11 prospective trials (428 patients) found that preoperative stereotactic body radiotherapy achieved a pathological complete response in about one-fifth of ER-positive, HER2-negative tumors, with severe late toxicity under 6% and excellent or good cosmetic results in roughly nine-tenths of cases. Longer time between radiation and surgery was the only factor that significantly boosted response, suggesting timing may be key to future trials.

Journal
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Q1)
Published
15 August 2026
Study design
Systematic review / meta-analysis of RCTs
Evidence level
Level 1, High (CEBM 1a)
Authors
Gustavo A Viani, Caio Viani Arruda, Ana Carolina Hamamura, Carlos E Cardoso, Helio A Salmon, Gustavo O Amaral
PMID
42603618
DOI
10.1016/j.radonc.2026.111743

Why clinicians should know about it

Abstract

BACKGROUND AND PURPOSE: Preoperative stereotactic body radiotherapy (SBRT) has emerged as a precision locoregional strategy for early luminal breast cancer, yet no quantitative meta-analysis exists in this subtype. We aimed to estimate the pooled pathological complete response (pCR) rate, identify its predictors through meta-regression, and characterise safety and cosmetic outcomes. MATERIALS AND METHODS: A systematic review and meta-analysis of prospective trials of preoperative SBRT in patients with clinical stage T1-T2 N0-N1 luminal (ER-positive, HER2-negative) breast cancer was conducted following PRISMA 2020 guidelines. Random-effects models with REML estimation were fitted on logit-transformed proportions. Univariable meta-regression analyses examined absorbed dose (BED_4), irradiation-to-surgery interval, fractionation, technique, and biological tumor characteristics as covariates. RESULTS: Eleven prospective studies (428 patients) were included. Eight trials (N = 277) reported pCR data, yielding a pooled pCR rate of 21.4 % (95 % CI: 12.1-35.1 %; I2 = 77.0 %). The irradiation-to-surgery interval was the sole statistically significant predictor of pCR (β = +0.045 per week; p < 0.001; R2 = 98.9 %), whilst BED_4, fractionation, and technique showed no independent association. Pooled late grade ≥ 3 toxicity was 5.9 % (95 % CI: 3.7-9.1 %) and excellent or good cosmesis was achieved in 88.3 % of patients (95 % CI: 79.4-93.6 %). CONCLUSION: Preoperative SBRT achieves a clinically meaningful pCR rate in early luminal breast cancer, with acceptable toxicity and preserved cosmesis. The irradiation-to-surgery interval is the dominant modifiable predictor of pathological response. Randomized trials prospectively optimizing this interval in the luminal subtype are warranted.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.