de Castro Douglas Guedes, Sanematsu Paulo Issamu, Pellizzon Antônio Cassio Assis, Suzuki Sérgio Hideki, Fogaroli Ricardo Cesar, Dias José Eduardo Souza, Gondim Guilherme Rocha Melo, Estrada Daniel Alvarez, Silva Maria Letícia Gobo, Rassi Marcio Saquy, Chen Michael Jenwei, Giacomelli Richard, Ramos Henderson, Neto Elson Santos, Abrahão Carolina Humeres, Coelho Tharcisio Machado, Yu Liao Shin, de Queiroz Tannous Cassio, Calsavara Vinicius Fernando, Giordano Frank Anton, de Oliveira Jean Gonçalves
Department of Radiation Oncology, A.C. Camargo Cancer Center, 01509-001, São Paulo, Brazil.
Department of Neurosurgery, A.C. Camargo Cancer Center, São Paulo, Brazil.
J Neurooncol. 2023 Mar;162(1):211-215. doi: 10.1007/s11060-023-04266-x. Epub 2023 Feb 24.
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.
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.
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.
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.
对脑转移瘤（BM）切除术后的手术腔进行局部立体定向放射外科治疗可降低局部复发率。评估术中放疗（IORT）治疗切除的BM后的局部控制（LC）和脑疾病控制（BDC）情况。
招募成年患者，其单个幕上BM已完全切除，并对手术腔进行IORT，规定剂量为18 Gy至1 mm深度。主要终点为精算LC和BDC。估计局部失败（LF）和远处脑失败（DBF），将死亡作为竞争风险。次要终点为总生存期（OS）和放射性坏死（RN）的发生率。采用西蒙两阶段设计，估计第一阶段分析纳入10例患者，若LC高于63%则进入第二阶段。我们报告第一阶段的最终分析结果。
2019年6月至2020年11月期间，共纳入10例患者。临床和影像学随访的中位时间分别为11.2个月和9.7个月。中位LC未达到，中位BDC为5个月。6个月和12个月时的LC分别为87.5%。6个月和12个月时的BDC分别为39%和13%。6个月和12个月时LF的发生率分别为10%，DBF的发生率分别为50%和70%。中位OS未达到。6个月和12个月时的OS为80%。1例患者出现无症状RN。
对完全切除的BM进行IORT与潜在的高局部控制率和低RN风险相关，达到了进入第二阶段的预先设定标准，值得进一步研究。
