A prospective phase II trial of hypofractionated stereotactic radiotherapy (FSRT) for patients with 1-10 brain metastases from breast cancer
Mené sur 173 patientes atteintes d'un cancer du sein et présentant des métastases cérébrales (durée médiane de suivi : 15 mois), cet essai de phase II évalue l'efficacité, du point de vue du taux de contrôle local, et la sécurité d'une radiothérapie stéréotaxique hypofractionnée (3 à 5 fractions de 8 Gy)
Purpose: While fractionated stereotactic radiotherapy (FSRT) remains understudied for the management of breast cancer brain metastases(BCBM), this study aimed to investigate its therapeutic efficacy and safety in the context of contemporary systemic therapies. We enrolled patients with 1–10 brain lesions.
Methods and Materials: This was a prospective, single-arm, phase II trial involving 173 breast cancer patients with 436 brain metastases, all treated with FSRT at a dose of 3-5 fractions of 8 Gy each. The primary endpoint was the local control rate, and secondary endpoints included the intracranial distant control rate, overall survival (OS) and central nervous system progression-free survival (CNS-PFS).
Results: With a median follow-up of 15 months, the 1-year local control rate was 88.6% and the 1-year intracranial distant control rate was 52.1% (95% CI: 44.7–60.8%). The median OS was 29 months (95% CI: 21–35 months), and the median CNS-PFS for patients with evaluable lesions was 12 months (95% CI: 9–16 months). Of the treated lesions, 27 out of 436 (6.2%) experienced radiation necrosis, no grade 3 or 4 FSRT-related adverse events were observed. Local control rates exceeded 86% at 1 year across all subtypes whereas the DMFS lower ranging from 39.7%-57.9%.
Conclusions: In this single-institution trial, FSRT at a dose of three to five 8 Gy fractions for breast cancer brain metastases yielded high local control with low rates of radiation necrosis in the background of modern systemic treatment.
International Journal of Radiation Oncology, Biology, Physics , résumé, 2026