Efficacy comparison of domestic gefitinib and original gefitinib as the first-line treatment for epidermal growth factor receptor sensitive mutation advanced non-small cell lung cancer / 肿瘤研究与临床

ABSTRACT

Objective:To investigate the efficacy differences between domestic gefitinib and original gefitinib in the first-line treatment of patients with epidermal growth factor receptor (EGFR) sensitive mutation advanced non-small cell lung cancer (NSCLC) (stage Ⅲ B and Ⅳ). Methods:A total of 91 cases with EGFR sensitive mutation advanced NSCLC in Dezhou People's Hospital of Shandong Province from January 2017 to July 2019 were selected and were randomly divided into the observation group (47 cases) and the control group (44 cases) according to random number table method. The observation group was given the treatment of domestic gefitinib, and the control group was given the treatment of original gefitinib, and then the treatment outcome, adverse reactions, survival status and the cost of two groups were compared.Results:The objective response rate in the observation group and the control group was 91.5% (43/47) and 84.1% (37/44), respectively; the disease control rate in the observation group and the control group was 100.0% (47/47) and 97.7% (43/44), respectively; and the differences were not statistically significant ( χ2 = 2.708, P = 0.224; χ2 = 1.080, P = 0.484). The median progression-free survival (PFS) time of domestic gefitinib group and original gefitinib group was 13.26 months (95% CI 11.34-14.66 months) and 13.19 months (95% CI 12.52-15.48 months), respectively, and the difference was not statistically significant ( P = 0.735). The subgroup analysis showed that the median PFS time of patients with an exon 19 deletion mutation in the observation group and the control group was 12.98 months (95% CI 11.25-14.75 months) and 13.89 months (95% CI 12.04-15.96 months), respectively, and the difference was not statistically significant ( P = 0.604). The median PFS time of patients with an exon 21 L858R missense mutation in the observation group and the control group was 15.08 months (95% CI 11.79-18.21 months) and 11.94 months (95% CI 9.20-14.79 months), and the difference was not statistically significant ( P = 0.114). There was no statistically difference in the incidence of adverse reactions including skin rash, diarrhea, interstitial pneumonia, oral mucositis, nausea and vomiting, myelosuppression, abnormal aminotransferase of the two groups of patients (all P > 0.05). The treatment cost in the observation group and the control group during the treatment period was (2 118.43±137.93) yuan per month and (5 945.48±247.48) yuan per month, respectively, and the difference was statistically significant ( t = 12.854, P = 0.001). Conclusions:Domestic gefitinib and original gefitinib have the same therapeutic efficacy in the treatment of EGFR sensitive mutation advanced NSCLC. The adverse reactions are similar between domestic gefitinib and original gefitinib. Compared with the original gefitinib, the drug economy of domestic gefitinib is better and it can significantly reduce the financial burden of patients, and it can be used as an important option in the first-line treatment of patients with EGFR sensitive mutation advanced NSCLC.