■当前治疗中小型前庭神经鞘瘤的指南建议要么预先进行放射外科治疗,要么等待放射学检查发现肿瘤生长。
■确定前期放射外科治疗小到中等大小的前庭神经鞘瘤是否比等待和扫描方法提供更好的肿瘤体积减小。
■对100例新诊断(<6个月)的单侧前庭神经鞘瘤患者进行随机临床试验,磁共振成像测得的桥小脑角最大肿瘤直径小于2cm。参与者从2014年10月28日至2017年10月3日在挪威国家前庭神经鞘瘤股注册;4年随访于2021年10月20日结束。
■参与者被随机分配接受预先放射外科(n=50)或接受等待和扫描协议,仅在影像学记录的肿瘤生长时给予治疗(n=50)。参与者进行了5次年度研究访问,包括临床评估,放射学检查,前庭检查,和问卷调查。
■主要结果是4年试验结束时的肿瘤体积与基线之间的比率(V4:V0)。有26个预设的次要结果,包括患者报告的症状,临床检查,前庭检查,和生活质量结果。安全性结果是挽救性显微外科手术和放射相关并发症的风险。
■在100名随机患者中,98人完成了试验,并被纳入主要分析(平均年龄,54岁;42%为女性)。在前期放射外科小组中,1名参与者(2%)在肿瘤生长后接受了重复的放射外科手术,2(4%)需要挽救显微外科手术,和45(94%)没有额外的治疗。在等待和扫描组中,21例患者(42%)在肿瘤生长后接受放射外科治疗,1人(2%)接受了挽救性显微外科手术,和28(56%)保持未处理。对于试验结束时肿瘤体积与基线之比的主要结果,前期放射外科组的几何平均值V4:V0为0.87(95%CI,0.66-1.15),等待扫描组为1.51(95%CI,1.23-1.84),在接受前期放射外科治疗的患者中显示出明显更大的肿瘤体积减少(等待和扫描与前期放射外科的比率,1.73;95%CI,1.23-2.44;P=.002)。在26个次要结果中,25无明显差别。未观察到辐射相关并发症。
■在新诊断的中小型前庭神经鞘瘤患者中,前期放射外科在4年时显示出明显大于等待和扫描方法的肿瘤体积减少。这些发现可能有助于前庭神经鞘瘤患者的治疗决策。需要进一步研究长期临床结局.
■ClinicalTrials.gov标识符:NCT02249572。
Current guidelines for treating small- to medium-sized vestibular schwannoma recommend either upfront radiosurgery or waiting to treat until tumor growth has been detected radiographically.
To determine whether upfront radiosurgery provides superior tumor volume reduction to a wait-and-scan approach for small- to medium-sized vestibular schwannoma.
Randomized clinical
trial of 100 patients with a newly diagnosed (<6 months) unilateral vestibular schwannoma and a maximal tumor diameter of less than 2 cm in the cerebellopontine angle as measured on magnetic resonance imaging. Participants were enrolled at the Norwegian National Unit for Vestibular Schwannoma from October 28, 2014, through October 3, 2017; 4-year follow-up ended on October 20, 2021.
Participants were randomized to receive either upfront radiosurgery (n = 50) or to undergo a wait-and-scan protocol, for which treatment was given only upon radiographically documented tumor growth (n = 50). Participants underwent 5 annual
study visits consisting of clinical assessment, radiological examination, audiovestibular tests, and questionnaires.
The primary outcome was the ratio between tumor volume at the
trial end at 4 years and baseline (V4:V0). There were 26 prespecified secondary outcomes, including patient-reported symptoms, clinical examinations, audiovestibular tests, and quality-of-life outcomes. Safety outcomes were the risk of salvage microsurgery and radiation-associated complications.
Of the 100 randomized patients, 98 completed the
trial and were included in the primary analysis (mean age, 54 years; 42% female). In the upfront radiosurgery group, 1 participant (2%) received repeated radiosurgery upon tumor growth, 2 (4%) needed salvage microsurgery, and 45 (94%) had no additional treatment. In the wait-and-scan group, 21 patients (42%) received radiosurgery upon tumor growth, 1 (2%) underwent salvage microsurgery, and 28 (56%) remained untreated. For the primary outcome of the ratio of tumor volume at the
trial end to baseline, the geometric mean V4:V0 was 0.87 (95% CI, 0.66-1.15) in the upfront radiosurgery group and 1.51 (95% CI, 1.23-1.84) in the wait-and-scan group, showing a significantly greater tumor volume reduction in patients treated with upfront radiosurgery (wait-and-scan to upfront radiosurgery ratio, 1.73; 95% CI, 1.23-2.44; P = .002). Of 26 secondary outcomes, 25 showed no significant difference. No radiation-associated complications were observed.
Among patients with newly diagnosed small- and medium-sized vestibular schwannoma, upfront radiosurgery demonstrated a significantly greater tumor volume reduction at 4 years than a wait-and-scan approach with treatment upon tumor growth. These findings may help inform treatment decisions for patients with vestibular schwannoma, and further investigation of long-term clinical outcomes is needed.
ClinicalTrials.gov Identifier: NCT02249572.