Zhigang Wei1, Xia Yang1, Xin Ye2, Qingliang Feng3, Yanjun Xu3, Licheng Zhang4, Wenqiao Sun4, Yuting Dong5, Qi Meng5, Tao Li5, Chuntang Wang6, Guangxu Li6, Kaixian Zhang7, Peishun Li7, Jingwang Bi8, Guoliang Xue8, Yahong Sun9, Lijun Sheng3, Bin Liu9, Guohua Yu10, Haipeng Ren10, Junye Wang11, Lijun Sun11, Shaoshui Chen12, Dianzhong Geng12, Benhua Zhang13, Xin Xu13, Liangming Zhang14, Dengjun Sun14, Xinglu Xu15, Cunqi Diao15, Guanghui Huang1, Wenhong Li1, Xiaoying Han1, Jiao Wang1, Min Meng1, Yang Ni1, Aimin Zheng1, Weijun Fan16, Yuliang Li17, Fan Li18, Hua Fan19, Zhigeng Zou1, Qingyu Li1, Hui Tian1. 1. Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China. 2. Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China. yexintaian2014@163.com. 3. Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China. 4. Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China. 5. Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China. 6. Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China. 7. Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China. 8. Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China. 9. Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China. 10. Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China. 11. Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China. 12. Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China. 13. Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China. 14. Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China. 15. Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China. 16. Department of Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China. 17. Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan, Shandong, China. 18. Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shanxi, China. 19. Public Health School, Taishan Medical University, Tai'an, Shandong, China.
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.
RCT Entities:
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.