前瞻性单臂单中心临床研究:肺恶性肿瘤的射频消融治疗

A prospective, single-arm, and single-center clinical trial: radiofrequency ablation of lung malignant tumors

目的研究肺恶性肿瘤射频消融治疗的安全性、可行性与治疗效果,探讨术后的疗效评估标准。方法 2012年1月—2013年9月,本前瞻性单臂单中心临床研究共入组27例患者,51个病灶行35次射频消融术,术后随访6~18个月。研究主要终点为安全性、可行性和局部疗效,次要终点为局部病灶无进展期(TTLP)、无进展生存期(PFS)、总生存期(OS)。结果 35次射频消融术无围手术期死亡发生,主要并发症为气胸11.4%(4/35),胸管引流率2.9%(1/35);肺出血8.6%(3/35),1例咯血(2.9%);胸腔积液8.6%(3/35),胸管引流率5.7%。51个病灶技术成功率为98.0%(50/51)。根据修订的实体肿瘤疗效评价标准(RECIST),随访至少6个月后,靶病灶完全缓解率为88.2%(45/51)。完全缓解病灶术后1个月较术前增大、术后6个月较术后1个月缩小,差异有显著统计学意义(P=0.000,P=0.002)。截至最后一次随访,TTLP为(10.0±2.8)个月,PFS为(8.0±3.0)个月,OS为(10.0±3.5)个月。结论肺恶性肿瘤射频消融治疗的安全性、可行性和肿瘤局部控制率高。射频术后局部疗效的评估采用修订的RECIST,以术后1个月为新基线,术后6个月后评价疗效,具有很好的临床应用价值,值得进一步推广。

Objective To investigate the safety, feasibility, and efficacy of radiofrequency ablation(RFA) of lung malignant tumors, and to explore evaluation criteria of response. Methods From January 2012 to September 2013, a total of 27 patients with 51 lung lesions were performed 35 sessions of radiofrequency ablation. These lesions were followed up for 6 to 18 months. The primary endpoints of the present study were safety, feasibility, and local effectiveness. The second endpoints were time to local progression(TTLP), progression-free survival(PFS) and overall survival(OS). Results No perioperative death occurred in any of the 35 sessions of radiofrequency ablation. The major complications were as follows: pneumothorax 11.4%(4/35), chest tube drainage 2.9%; lung parenchyma hemorrhage 8.6%(3/35), hemoptysis 2.9%; pleural effusion 8.6%(3/35), chest tube drainage 5.7%. The technical success rate was 98.0%(50/51). According to the revised Response Evaluation Criteria in Solid Tumors(RECIST), the complete response rate of target lesions was 88.2%(45/51) lasting at least 6-month postablation. The lesion size of complete response at 1-month postablation was larger than the original size, while smaller than that at 6-month postablation, with significant differences(P=0.000, P=0.002). To the last follow-up, the time to local progression, progression-free survival and overall survival was(10.0±2.8),(8.0±3.0), and(10.0±3.5) months, respectively. Conclusion Radiofrequency ablation yields high safety, feasibility and local control of lung malignant tumors. It is of great clinical value in evaluation of local efficacy by revised RECIST, taking 1-month postablation as a new baseline and evaluating local efficacy at 6-month postablation.