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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

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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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Abbreviations

AUC:

Area under the curve

CI:

Confident interval

CTCAE:

Common Terminology Criteria Adverse Events Version

DCR:

Disease control rate

ECOG:

Eastern Cooperation Oncology Group

EGFR:

Epidermal growth factor receptor

EML4-ALK:

Echinoderm microtubule–associated protein-like 4-anaplastic lymphoma kinase

GGO:

Ground glass opacity

HR:

Hazard ratio

MWA:

Microwave ablation

NSCLC:

Non-small cell lung cancer

ORR:

Objective response rate

OS:

Overall survival

PD-L1:

Program death-ligand 1

PFS:

Progression-free survival

PS:

Performance status

RECIST:

Response Evaluation Criteria in Solid Tumors

SIR:

Society of Interventional Radiology

TKIs:

Tyrosine kinase inhibitors

TTLP:

Time to local progression

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Acknowledgments

The authors thank Professor Luigi Solbiati for medical writing assistance.

Funding

This study has received funding from the Funding Development Center for Medical Science and Technology National Health and Family Planning Commission of People’s Republic of China (W2015XR03), Shandong Province Medical and Health Science and Technology Development Projects (2014WS0346), and Technology Development Project the China international Medical Exchange Foundation (2012G0021824).

Author information

Author notes

  1. Zhigang Wei and Xia Yang contributed equally to this work.

Authors and Affiliations

  1. Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China

    Zhigang Wei, Xia Yang, Xin Ye, Guanghui Huang, Wenhong Li, Xiaoying Han, Jiao Wang, Min Meng, Yang Ni, Aimin Zheng, Zhigeng Zou, Qingyu Li & Hui Tian

  2. Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China

    Qingliang Feng, Yanjun Xu & Lijun Sheng

  3. Department of Oncology, The People’s Liberation Army 88 Hospital, Tai’an, Shandong, China

    Licheng Zhang & Wenqiao Sun

  4. Department of Oncology, Dezhou People’s Hospital, Dezhou, Shandong, China

    Yuting Dong, Qi Meng & Tao Li

  5. Department of Thoracic Surgery, The Second People’s Hospital of Dezhou, Dezhou, Shandong, China

    Chuntang Wang & Guangxu Li

  6. Department of Oncology, Tengzhou Central People’s Hospital, Zaozhuang, Shandong, China

    Kaixian Zhang & Peishun Li

  7. Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China

    Jingwang Bi & Guoliang Xue

  8. Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China

    Yahong Sun & Bin Liu

  9. Department of Oncology, Weifang People’s Hospital, Weifang, Shandong, China

    Guohua Yu & Haipeng Ren

  10. Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China

    Junye Wang & Lijun Sun

  11. Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China

    Shaoshui Chen & Dianzhong Geng

  12. Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai’an, Shandong, China

    Benhua Zhang & Xin Xu

  13. Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China

    Liangming Zhang & Dengjun Sun

  14. Department of Oncology, The People’s Hospital of Pingyi Country, Linyi, Shandong, China

    Xinglu Xu & Cunqi Diao

  15. Department of Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

    Weijun Fan

  16. Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan, Shandong, China

    Yuliang Li

  17. Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi’an, Shanxi, China

    Fan Li

  18. Public Health School, Taishan Medical University, Tai’an, Shandong, China

    Hua Fan

Authors
  1. Zhigang Wei
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  2. Xia Yang
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  3. Xin Ye
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  4. Qingliang Feng
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  5. Yanjun Xu
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  37. Yang Ni
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  39. Weijun Fan
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  40. Yuliang Li
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  41. Fan Li
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  42. Hua Fan
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  43. Zhigeng Zou
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  44. Qingyu Li
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  45. Hui Tian
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Corresponding author

Correspondence to Xin Ye.

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Guarantor

The scientific guarantor of this publication is Xin Ye.

Conflict of interest

The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.

Statistics and biometry

Both Fan Li and Hua Fan have significant statistical expertise.

Informed consent

Written informed consent was obtained from all subjects patients in this study.

Ethical approval

Institutional Review Board approval was obtained from all centers.

Methodology

• prospective

• randomized controlled trial

• multicenter study

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Wei, Z., Yang, X., Ye, X. et al. Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial. Eur Radiol 30, 2692–2702 (2020). https://doi.org/10.1007/s00330-019-06613-x

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