Tanigawa Noboru, Arai Yasuaki, Yamakado Koichiro, Aramaki Takeshi, Inaba Yoshitaka, Kanazawa Susumu, Matsui Osamu, Miyazaki Masaya, Kodama Yoshihisa, Anai Hiroshi, Hamanaka Akihiro
Department of Radiology, Kansai Medical University, Hirakata, Japan.
Department of Diagnostic Radiology, National Cancer Center, Tokyo, Japan.
Cardiovasc Intervent Radiol. 2018 Jul;41(7):1043-1048. doi: 10.1007/s00270-018-1944-x. Epub 2018 Apr 12.
A prospective multicenter phase I/II trial was performed to evaluate the clinical safety and efficacy of radiofrequency ablation (RFA) for metastatic bone tumors.
Thirty-three patients (27 men, 6 women, mean age 61 years) with metastatic bone tumors were enrolled. In phase I, nine patients were enrolled, and the safety of RFA was evaluated. In phase II, 23 patients were included, and an intent-to-treat analysis was performed. The primary endpoint was to evaluate the treatment's safety. The secondary endpoint was to evaluate the efficacy of pain relief at 1 week after RFA.
RFA was performed in 32 of 33 enrolled patients. No serious complications were observed during the phase I, so phase II was performed. Four patients exhibited adverse events, including one case each of Grade 3 pain and, Grade 2 hypotension, and one patient developed Grade 1 burns at the grounding pad and puncture site. One patient died of liver failure on day 7 after RFA due to the progression of the primary lesion. The efficacy was excellent (no increase in analgesic dosage, post-RFA VAS score of 0-2 or decreased by not less than 5 compared to before RFA) in 20 patients (60.6%), good (no increase in analgesic dosage, post-RFA VAS score decreased by not less than 2 but by < 5 compared to before RFA) in 3 (9.1%), and poor in 10 patients (30.3%). Thus, the response rate was 69.7%.
RFA is a safe and effective method for treating painful metastatic bone tumors.
开展一项前瞻性多中心I/II期试验，以评估射频消融（RFA）治疗转移性骨肿瘤的临床安全性和疗效。
纳入33例转移性骨肿瘤患者（27例男性，6例女性，平均年龄61岁）。I期纳入9例患者，评估RFA的安全性。II期纳入23例患者，并进行意向性分析。主要终点是评估治疗的安全性。次要终点是评估RFA后1周时疼痛缓解的疗效。
33例入组患者中有32例接受了RFA治疗。I期未观察到严重并发症，因此进行了II期试验。4例患者出现不良事件，包括1例3级疼痛、1例2级低血压，1例患者在接地垫和穿刺部位出现1级烧伤。1例患者在RFA后第7天因原发病变进展死于肝功能衰竭。20例患者（60.6%）疗效极佳（镇痛剂量未增加，RFA后视觉模拟评分（VAS）为0 - 2分或较RFA前降低不少于5分），3例患者（9.1%）疗效良好（镇痛剂量未增加，RFA后VAS评分较RFA前降低不少于2分但<5分），10例患者（30.3%）疗效较差。因此，有效率为69.7%。
RFA是治疗疼痛性转移性骨肿瘤的一种安全有效的方法。
