Abstract

From October 2013 there is a possibility to treat patients with NSCLC and with activated epidermal growth factor receptor (EGFR) mutations with three TKI in the Czech Republic. We have tried to find differences among patient groups treated with single TKI in 1st line of treatment. The TULUNG registry was used as a data source for this analysis. This clinical registry is focused on the collection of epidemiological and clinical data of patients with NSCLC treated with target therapy in the Czech Republic. A total of 959 patients treated with TKI inhibitors was enrolled in registry until December 31, 2018. Only patients with EGFR mutation and in which 1st line treatment started in October 2013 and later were included in analysis. With respect to defined inclusion criteria we analysed 470 patients. With gefitinib were treated 234, with afatinib 180 and with erlotinib 56 patients. Descriptive statistics and frequency tables were used to characterize the sample data set. Statistical significance of differences among three TKI inhibitors subgroups was assessed using the Fisher’s exact test or Kruskal-Wallis test for continuous variables. OS and PFS were estimated using Kaplan-Meier method and all point estimates include 95% confidence intervals (95% CI). Statistical significance of differences in survival between subgroups was assessed using the log-rank test. All statistical tests were performed at a significance level of α=0.05. There was statistically significant difference according to age (<0.001) and PS (<0.001), patients treated with gefitinib were statistically significant older and had significantly significant higher PS than patients treated with afatinib and erlotinib There was statistically significant difference in the occurrence of adverse events (p<0.001). Patients treated with gefitinib had a significantly lower incidence of adverse events than patients treated with afatinib and erlotinib. Between these three groups of patients there was no statistically significant difference in sex (p=0.863), in smoking habits (p=0.463, in type of EGFR mutation (p=0.103), in adenocarcinoma proportion (p=0.183). There was no statistically significant difference according to disease control (p=0.183), in response to treatment (p = 0.804), in OS and (p=0.053, in PFS (p=0.06). Between these three groups of patients we found a statistically significant difference in age, PS segmentation and in occurrence of adverse events. We have not found any important statistically difference in sex, smoking, in histology type of EGFR mutation, difference in response to treatment, in disease control and OS.

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