A randomized clinical study of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local-advanced non-small cell lung cancer with sensitive EGFR mutations
10.3760/cma.j.issn.1008-6706.2019.08.012
- VernacularTitle:吉非替尼联合胸部同步放疗治疗局部晚期存在敏感基因突变非小细胞肺癌的临床研究
- Author:
Chuan ZHU
1
;
Zuai CAI
;
Xiangyi LI
;
Deming XIONG
;
Biyong REN
;
Shichuan CHANG
;
Jianjun TAN
;
Yue QIN
;
Xun CHENG
Author Information
1. 重庆三峡中心医院肿瘤防治中心 443000
- Keywords:
Carcinoma,non-small-cell lung;
Gefitinib;
Radiotherapy;
Antineoplastic combined chem-otherapy protocols;
Comparative effectiveness research
- From:
Chinese Journal of Primary Medicine and Pharmacy
2019;26(8):943-948
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local - advanced non - small cell lung cancer with sensitive EGFR mutations. Methods From June 2015 to December 2016,fifty-six eligible patients in Chongqing Three Gorges Central Hospital were randomly assigned into two groups by one to one ratio,with 28 cases in each group.A group received treatment of gefitinib combined with concurrent thoracic radiotherapy, and B group adopted concurrent chemoradiotherapy. The toxic effects were recorded and all patients were followed up as defined by the study protocol.Primary study endpoints included:severe toxic effects,objective response rate and disease control rate,progression free survival and overall survival.Results Twenty-six patients in A group completed the study,and the severe toxic effects were as followed:interstitial pneumonia(3/26),radiation esophagitis(4/26),myelosuppression,skin rashes and gastrointestinal disruption. Twenty- eight patients in B group completed the study, and the severe toxicity included: interstitial pneumonia (4/26),radiation esophagitis(3/26),myelosuppression,skin rashes and gastrointestinal disruption.No toxicity higher than gradeⅢdeveloped in both two groups,and there were no statistically significant differences in incidence rates of interstitial pneumonia and radiation esophagitis between the two groups ( all P >0. 05 ). Moreover, there were no statistically significant differences in ORR and DCR between the two groups( ORR:61.5% vs.39.3% ,P=0.102;DCR:84. 6% vs. 71. 4% , P =0. 505 ). A group showed the benefit over B group in PFS ( 12. 45 months vs. 10.35 months,P=0.036).However,OS didn＇t reach and needed further follow-up.Conclusion The modality of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local -advanced non -small cell lung cancer with sensitive EGFR mutations is safe and effective,and it yet needs further follow-up.
