Efficacy and Safety of Osimertinib in the Treatment of EGFR-mutated Advanced Non-small Cell Lung Cancer：A Meta-analysis

doi:10.19803/j.1672-8629.2021.02.17

Abstract

Abstract: Objective To evaluate the efficacy and safety of osimertinib in the treatment of non-small cell lung cancer (NSCLC). Methods RCTs related to osimertinib used for treating NSCLC were collected by searching PubMed, EMbase, the Cochrane Library, CNKI, VIP and Wanfang database from the beginning to December 31, 2019. After quality evaluation and information retrieval,a meta-analysis was conducted using Stata 12.0 software. Results A total of 8 studies and 1 795 patients were included. Meta analysis results showed that the progression-free survival (PFS), Objective response rate (ORR), and disease control rate (DCR) of the osimertinib group were better than those of the control group, and their differences were statistically significant (all P<0.05). In the subgroup analysis, for patients with Ex19del / L858R mutations, the PFS, ORR and DCR achieved with osimertinib as a first-line therapy were better than those of the first-generation EGFR-TKIs (gefitinib/erlotinib), and their differences were statistically significant. except for ORR (all P<0.05). For patients with T790M mutations, PFS, ORR, and DCR achieved with osimertinib as a second-line treatment were better than those of chemotherapy, and their difference were also statistically significant (all P<0.05). As for safety, the incidence of adverse drug reactions (ADRs) and grade≥3 ADRs in the osimertinib group was lower than that of the control group, but there was no significant difference in the incidence of ADRs (P>0.05). In addition, the incidence of diarrhea, interstitial lung disease, prolonged QT interval, and rash/acne was significantly. whether it is first-line medication or second-line and above medication after T790M mutation. higher in the osimertinib group than in the control group. Conclusion For patients with EGFR-mutant NSCLC, whether it is first-line medicaation or second-line and above medication after T 790M mutation osimertinib is more effective and can reduce the incidence of grade ≥3 ADRs, but there is safety risk.

Key words: osimertinib, non-small cell lung cancer, efficacy, safety, Meta-analysis

CLC Number:

R994.1

ZHANG Conghui, XIE Yanjun, PENG Tingting, LU Yan, GUO Linlin, LIU Jian. Efficacy and Safety of Osimertinib in the Treatment of EGFR-mutated Advanced Non-small Cell Lung Cancer：A Meta-analysis[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 178-183.

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