Intraoperative radiotherapy for brain metastases: first-stage results of a single-arm, open-label, phase 2 trial.

Autor: de Castro DG; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil. douglas.castro@accamargo.org.br., Sanematsu PI Jr; Department of Neurosurgery, A.C. Camargo Cancer Center, São Paulo, Brazil., Pellizzon ACA; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Suzuki SH; Department of Neurosurgery, A.C. Camargo Cancer Center, São Paulo, Brazil., Fogaroli RC; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Dias JES Jr; Department of Neurosurgery, A.C. Camargo Cancer Center, São Paulo, Brazil., Gondim GRM; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Estrada DA; Department of Neurosurgery, A.C. Camargo Cancer Center, São Paulo, Brazil., Silva MLG; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Rassi MS; Department of Neurosurgery, A.C. Camargo Cancer Center, São Paulo, Brazil., Chen MJ; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Giacomelli R; Department of Neurosurgery, A.C. Camargo Cancer Center, São Paulo, Brazil., Ramos H; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Neto ES; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Abrahão CH; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Coelho TM; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Yu LS; Department of Imaging, A.C. Camargo Cancer Center, São Paulo, Brazil., de Queiroz Tannous C; Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil., Calsavara VF; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, USA., Giordano FA; Department of Radiation Oncology, DKFZ-Hector Cancer Institute, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., de Oliveira JG; Division of Neurosurgery, Department of Surgery, Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: Journal of neuro-oncology [J Neurooncol] 2023 Mar; Vol. 162 (1), pp. 211-215. Date of Electronic Publication: 2023 Feb 24.
DOI: 10.1007/s11060-023-04266-x
Abstrakt: Objective: Focal stereotactic radiosurgery to the surgical cavity lowers local recurrence after resection of brain metastases (BM). To evaluate local control (LC) and brain disease control (BDC) after intraoperative radiotherapy (IORT) for resected BM.
Methods: Adult patients with completely resected single supratentorial BM were recruited and underwent IORT to the cavity with a prescribed dose of 18 Gy to 1 mm-depth. Primary endpoints were actuarial LC and BDC. Local failure (LF) and distant brain failure (DBF), with death as a competing risk, were estimated. Secondary endpoints were overall survival (OS) and incidence of radiation necrosis (RN). Simon's two-stage design was used and estimated an accrual of 10 patients for the first-stage analysis and a LC higher than 63% to proceed to second stage. We report the final analysis of the first stage.
Results: Between June 2019 to November 2020, 10 patients were accrued. Median clinical and imaging FU was 11.2 and 9.7 months, respectively. Median LC was not reached and median BDC was 5 months. The 6-month and 12-month LC was 87.5%. The 6-month and 12-month BDC was 39% and 13%, respectively. Incidence of LF at 6 and 12 months was 10% and of DBF at 6 and 12 months was 50% and 70%, respectively. Median OS was not reached. The 6-month and 12-month OS was 80%. One patient had asymptomatic RN.
Conclusion: IORT for completely resected BM is associated with a potential high local control and low risk of RN, reaching the pre-specified criteria to proceed to second stage and warranting further studies.
(© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE