Miyazaki Masaya, Saito Kenichi, Yanagawa Takashi, Chikuda Hirotaka, Tsushima Yoshito
Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan.
Department of Orthopedic Surgery, Gunma University Hospital, 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan.
Jpn J Radiol. 2018 Nov;36(11):669-675. doi: 10.1007/s11604-018-0768-6. Epub 2018 Aug 14.
This prospective phase I trial was conducted to evaluate the safety of percutaneous cryoablation for osteoid osteoma (OO).
Nine patients with OO (mean tumor size: 5.9 mm; tibia, n = 5; femur, n = 2; lumbar spine, n = 2) were enrolled and treated with percutaneous cryoablation. The primary endpoint was the evaluation of the treatment safety as determined using step-by-step registration. The secondary endpoints were the incidence and grade of adverse events by CTCAE version 4.0, and the short-term efficacy of this treatment. Based on a decrease in the numerical rating scale (NRS) score, efficacy was classified as significantly effective (SE ≥ 5 or reached 0-2), moderately effective (ME 2-4), or not effective (NE < 2 or increase).
Cryoablation procedures were completed in all patients. Major adverse events (≥ grade 3) related to the procedure were not observed. Minor adverse events (≤ grade2) were observed in 22-67%. The mean NRS score was 7 before treatment, 0.6 at 4-week, 0.1 at 6-month, and 0 at 1-year post-treatment. All procedures were classified as SE.
Percutaneous cryoablation is a safe treatment for OO. Future phase II trials with large patient cohorts are warranted.
本前瞻性I期试验旨在评估经皮冷冻消融治疗骨样骨瘤（OO）的安全性。
纳入9例骨样骨瘤患者（平均肿瘤大小：5.9 mm；胫骨5例，股骨2例，腰椎2例），接受经皮冷冻消融治疗。主要终点是通过逐步登记确定治疗安全性的评估。次要终点是根据CTCAE 4.0版评估不良事件的发生率和分级，以及该治疗的短期疗效。根据数字评分量表（NRS）评分的降低情况，疗效分为显著有效（SE≥5或降至0 - 2）、中度有效（ME 2 - 4）或无效（NE < 2或升高）。
所有患者均完成冷冻消融手术。未观察到与手术相关的严重不良事件（≥3级）。22% - 67%的患者观察到轻微不良事件（≤2级）。治疗前NRS平均评分为7分，治疗后4周为0.6分，6个月为0.1分，1年为0分。所有手术均分类为显著有效。
经皮冷冻消融是治疗骨样骨瘤的一种安全治疗方法。未来有必要开展更大患者队列的II期试验。
