Clinical study of gefitinib maintenance therapy after concurrent radiotherapy and chemotherapy for locally advanced NSCLC with EGFR sensitive mutations.

Abstract

87 Background: To investigate the value of Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in the maintenance therapy of locally advanced NSCLC after concurrent radiotherapy and chemotherapy. Methods: From Jan 2010 to Jan 2015, 166 patients with locally advanced NSCLC were treated in JCH. Total 86 patients with no progress after concurrent radiotherapy and chemotherapy were selected. Within 2 to 6 weeks after therapy, eligible patients received TKI (Gefitinib 250mg/day) or were observed for 1 year. If disease progresses or intolerable adverse reactions occur, the treatment should be discontinued. Chest and abdomen CT exam were performed 2 weeks before TKI treatment, and every 2 months thereafter. The same assessment techniques were used throughout the study. Therapeutic evaluation refers to the RECIST. SPSS 19.0 was used for data analysis and processing. Survival analysis was performed by Kaplan-Meier method. Results: In TKI drug group, CR 6 cases, PR 18 cases, SD 12 cases, PD 7 cases; in observation group, CR 3 cases, PR 11 cases, SD 13 cases, PD 16 cases. The CR + PR were 54.5% and 31.8% respectively, P = 0.031. The CR + PR + SD were 81.8% and 61.4% respectively, P = 0.033. The objective remission rate and disease control rate of TKI group were higher than those of observation group. The TTP in TKI group was 13.6 months (CI: 12.88-14.32 months) and that in observation group was 10.8 months (CI: 9.87-11.73 months), P = 0.001. The median OS of TKI group was 34.5 months (CI: 32.12-36.88 months) and that of observation group was 30.3 months (CI: 28.64-31.96 months), P = 0.029. Conclusions: 1. The objective remission rate and disease control rate of TKI group were higher than those of placebo group. 2. Ohitinib was not on the market in China at the time of this study and economic reason, so palliative chemotherapy was the main way to treat condition, and no third-generation TKI drugs were used. This may be one of the reasons why the total OS in this study was not long. 3. TKI drugs can improve the disease control rate and prolong the survival time of patients with locally advanced NSCLC after concurrent radiotherapy and chemotherapy, and have less side effects.