Dataset related to article "Surgery Followed by Hypofractionated Radiosurgery on the Tumor Bed in Oligometastatic Patients With Large Brain Metastases. Results of a Phase 2 Study"

PURPOSE: This prospective phase II study assessed safety and feasibility of surgery followed by hypofractionated radiosurgery (HSRS) on the tumor bed in oligometastatic patients with single large brain metastases (BMs). METHODS AND MATERIALS: Between June 2015 and May 2018, 101 patients were enrolled. Oligometastatic disease was defined by a maximum of 5 extracranial metastatic lesions. HSRS was performed within 1 month of surgery and consisted of 30 Gy in 3 fractions. Local control, occurrence of new BMs, overall survival, and treatment-related toxicities were assessed. RESULTS: At a median follow-up time of 26 months, local recurrence occurred in 6 patients (5.9%). Six-month, 1-year, and 2-year local control rates were 100%, 98.9% ± 1.1%, and 85.9% ± 0.6%, respectively. New BMs occurred in 39 patients (38.6%); median brain distant progression time and 6-month, 1-year, and 2-year brain distant progression rates were 39 months (95% CI, 19-39 months), 17% ± 3.7%, 31.4% ± 4.8%, and 42.5% ± 5.9%, respectively. At the last observation time, 50 patients (49.5%) were alive and 51 (50.5%) were dead; 10 patients died owing to neurologic causes and 40 as a result of systemic progression. Median overall survival time and 6-month, 1-year, and 2-year overall survival rates were 22 months (95% CI, 20-30 months), 95% ± 2.1%, 81.9% ± 3.8%, and 46.6% ± 6%, respectively. Infratentorial site, residual tumor volume, longer interval time between primary diagnosis and occurrence of BMs, and oligometastatic disease status significantly influenced outcome. Grade 2 to 3 radionecrosis occurred in 26 patients. Neurocognitive functions remained stable or, in some cases, improved. CONCLUSIONS: Surgery followed by HSRS on the tumor bed is a safe and effective approach, affording good brain control with acceptable toxicities. As for extracranial metastatic sites, patients with BMs can benefit from local ablative treatment in the context of an oligometastatic disease.一、研究目的 本前瞻性II期临床试验评估了单发大体积脑转移瘤（brain metastases, BMs）寡转移患者术后针对瘤床实施大分割立体定向放射外科（hypofractionated radiosurgery, HSRS）的安全性与可行性。 二、材料与方法 2015年6月至2018年5月，共纳入101例患者。寡转移疾病定义为颅外转移病灶最多不超过5个。患者于术后1个月内接受HSRS治疗，方案为3次分割，总剂量30戈瑞（Gy）。本研究评估的终点包括局部控制率、新发脑转移瘤发生率、总生存期及治疗相关毒性反应。 三、研究结果 中位随访26个月时，共6例（5.9%）患者出现局部复发。6个月、1年及2年局部控制率分别为100%、98.9%±1.1%与85.9%±0.6%。39例（38.6%）患者出现新发脑转移瘤；中位脑远处进展时间为39个月（95%置信区间[CI]：19~39个月），6个月、1年及2年脑远处进展率分别为17%±3.7%、31.4%±4.8%与42.5%±5.9%。末次随访时，50例（49.5%）患者存活，51例（50.5%）死亡；其中10例死于神经系统原因，40例死于全身病变进展。中位总生存期为22个月（95%置信区间[CI]：20~30个月），6个月、1年及2年总生存率分别为95%±2.1%、81.9%±3.8%与46.6%±6%。幕下病灶部位、残余肿瘤体积、原发肿瘤确诊至脑转移瘤发生的间隔时长及寡转移疾病状态均对预后存在显著影响。26例患者出现2~3级放射性坏死。患者神经认知功能保持稳定，部分患者甚至有所改善。 四、研究结论 术后针对瘤床实施大分割立体定向放射外科治疗是一种安全有效的治疗方案，可实现良好的颅内病灶控制，且毒性反应可接受。对于伴脑转移瘤的寡转移患者，局部消融治疗可使其在颅外转移病灶层面获益。