Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.
Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.
Eur Radiol. 2020 May;30(5):2692-2702. doi: 10.1007/s00330-019-06613-x. Epub 2020 Feb 4.
This prospective trial was performed to verify whether microwave ablation (MWA) in combination with chemotherapy could provide superior survival benefit compared with chemotherapy alone.
From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC) were randomly assigned to MWA plus chemotherapy group or chemotherapy group. The primary endpoint was progression-free survival (PFS), while the secondary endpoints included overall survival (OS), time to local progression (TTLP), and objective response rate (ORR). The complications and adverse events were also reported.
A total of 293 patients were randomly assigned into the two groups. One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group. One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group. The median follow-up period was 13.1 months and 12.4 months, respectively. Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001). Median OS was not reached in the MWA plus chemotherapy group and 12.6 months (95% CI 10.6-14.6) in the chemotherapy group (HR = 0.38, 95% CI 0.27-0.53; p < 0.0001) using Kaplan-Meier analyses with log-rank test. The median TTLP was 24.5 months, and the ORR was 32% in both groups. The adverse event rate was not significantly different in the two groups.
In patients with advanced NSCLC, longer PFS and OS can be achieved with the treatment of combined MWA and chemotherapy than chemotherapy alone.
• Patients treated with MWA plus chemotherapy had superior PFS and OS over those treated with chemotherapy alone. • The ORR of patients treated with MWA plus chemotherapy was similar to that of those treated with chemotherapy alone. • Complications associated with MWA were common but tolerable and manageable.
本前瞻性试验旨在验证微波消融（MWA）联合化疗是否比单纯化疗更能提供生存获益。
自 2015 年 3 月 1 日至 2017 年 6 月 20 日，对经病理证实的晚期或复发性非小细胞肺癌（NSCLC）初治患者进行随机分组，分别接受 MWA 联合化疗或化疗。主要终点为无进展生存期（PFS），次要终点包括总生存期（OS）、局部进展时间（TTLP）和客观缓解率（ORR）。同时报告了并发症和不良反应。
共 293 例患者被随机分配到两组。148 例 117 例 IV 期肿瘤患者被纳入 MWA 联合化疗组，145 例 113 例 IV 期肿瘤患者被纳入化疗组。中位随访时间分别为 13.1 个月和 12.4 个月。MWA 联合化疗组的中位 PFS 为 10.3 个月（95%CI8.0-13.0），化疗组为 4.9 个月（95%CI4.2-5.7）（HR=0.44，95%CI0.28-0.53；p<0.0001）。MWA 联合化疗组中位 OS 未达到，化疗组为 12.6 个月（95%CI10.6-14.6）（HR=0.38，95%CI0.27-0.53；p<0.0001）。采用对数秩检验的 Kaplan-Meier 分析。两组中位 TTLP 为 24.5 个月，ORR 均为 32%。两组不良反应发生率无显著差异。
在晚期 NSCLC 患者中，MWA 联合化疗治疗可获得更长的 PFS 和 OS，优于单纯化疗。
接受 MWA 联合化疗的患者的 PFS 和 OS 优于接受单纯化疗的患者。
接受 MWA 联合化疗的患者的 ORR 与接受单纯化疗的患者相似。
MWA 相关并发症常见，但可耐受且可管理。
