Erschienen in:
24.02.2023 | Case Study
Intraoperative radiotherapy for brain metastases: first-stage results of a single-arm, open-label, phase 2 trial
verfasst von:
Douglas Guedes de Castro, Paulo Issamu Sanematsu Jr., Antônio Cassio Assis Pellizzon, Sérgio Hideki Suzuki, Ricardo Cesar Fogaroli, José Eduardo Souza Dias Jr., Guilherme Rocha Melo Gondim, Daniel Alvarez Estrada, Maria Letícia Gobo Silva, Marcio Saquy Rassi, Michael Jenwei Chen, Richard Giacomelli, Henderson Ramos, Elson Santos Neto, Carolina Humeres Abrahão, Tharcisio Machado Coelho, Liao Shin Yu, Cassio de Queiroz Tannous, Vinicius Fernando Calsavara, Frank Anton Giordano, Jean Gonçalves de Oliveira
Erschienen in:
Journal of Neuro-Oncology
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Ausgabe 1/2023
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Abstract
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.