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

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 grade Ⅲ developed 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. Key words: Carcinoma, non-small-cell lung; Gefitinib; Radiotherapy; Antineoplastic combined chemotherapy protocols; Comparative effectiveness research