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04.02.2020 | Chest

Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial

verfasst von: Zhigang Wei, Xia Yang, Xin Ye, Qingliang Feng, Yanjun Xu, Licheng Zhang, Wenqiao Sun, Yuting Dong, Qi Meng, Tao Li, Chuntang Wang, Guangxu Li, Kaixian Zhang, Peishun Li, Jingwang Bi, Guoliang Xue, Yahong Sun, Lijun Sheng, Bin Liu, Guohua Yu, Haipeng Ren, Junye Wang, Lijun Sun, Shaoshui Chen, Dianzhong Geng, Benhua Zhang, Xin Xu, Liangming Zhang, Dengjun Sun, Xinglu Xu, Cunqi Diao, Guanghui Huang, Wenhong Li, Xiaoying Han, Jiao Wang, Min Meng, Yang Ni, Aimin Zheng, Weijun Fan, Yuliang Li, Fan Li, Hua Fan, Zhigeng Zou, Qingyu Li, Hui Tian

Erschienen in: European Radiology | Ausgabe 5/2020

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Abstract

Objectives

This prospective trial was performed to verify whether microwave ablation (MWA) in combination with chemotherapy could provide superior survival benefit compared with chemotherapy alone.

Materials and methods

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.

Results

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.

Conclusions

In patients with advanced NSCLC, longer PFS and OS can be achieved with the treatment of combined MWA and chemotherapy than chemotherapy alone.

Key Points

• 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.

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Titel: Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial
verfasst von: Zhigang Wei
Xia Yang
Xin Ye
Qingliang Feng
Yanjun Xu
Licheng Zhang
Wenqiao Sun
Yuting Dong
Qi Meng
Tao Li
Chuntang Wang
Guangxu Li
Kaixian Zhang
Peishun Li
Jingwang Bi
Guoliang Xue
Yahong Sun
Lijun Sheng
Bin Liu
Guohua Yu
Haipeng Ren
Junye Wang
Lijun Sun
Shaoshui Chen
Dianzhong Geng
Benhua Zhang
Xin Xu
Liangming Zhang
Dengjun Sun
Xinglu Xu
Cunqi Diao
Guanghui Huang
Wenhong Li
Xiaoying Han
Jiao Wang
Min Meng
Yang Ni
Aimin Zheng
Weijun Fan
Yuliang Li
Fan Li
Hua Fan
Zhigeng Zou
Qingyu Li
Hui Tian
Publikationsdatum: 04.02.2020
Verlag: Springer Berlin Heidelberg
Erschienen in: European Radiology / Ausgabe 5/2020
Print ISSN: 0938-7994
Elektronische ISSN: 1432-1084
DOI: https://doi.org/10.1007/s00330-019-06613-x

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Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial