Background: Osimertinib is an EGFR-TKI that is selective for both EGFR-TKI-sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer (NSCLC). The purpose of this study was conducting a meta-analysis to evaluate the clinical efficacy and safety of osimertinib in the treatment for NSCLC.
Methods: Using "osimertinib" as a keyword combined with "non-small-cell lung cancer" and "randomized controlled trial" as medical subject headings, the following electronic databases were searched: PubMed, EMBASE, Cochrane Library, and China National Knowledge Infrastructure. After data extraction and quality assessment of the included randomized controlled trials, the RevMan 5.3 software and R meta package were applied for meta-analysis of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results: Ten studies met our criteria and were included in the meta-analysis, with a total of 3,260 participants. The meta-analysis showed that osimertinib therapy was superior to the control therapy alone in ORR (combined RR=1.53, 95% CI: 0.87-2.71, P=0.14), DCR (combined RR=1.07, 95% CI: 0.79-1.44, P=0.66), PFS (combined RR=0.32, 95% CI: 0.24-0.44, P<0.00001), and OS (combined RR=0.57, 95% CI: 0.47-0.70, P<0.00001). In addition, osimertinib led to some toxicities, and the overall prevalence of all-grade diarrhea was 40% (95% CI: 33-47), paronychia 26% (95% CI: 20-33), rash 40% (95% CI: 34-47), dry skin 28% (95% CI: 23-33), and stomatitis 15% (95% CI: 9-23).
Conclusion: Our study showed that osimertinib demonstrated a significant improvement in the ORR, DCR, PFS, and OS with tolerable adverse effects for NSCLC patients. However, because of some clear limitations (heterogeneity and publication bias), these results should be interpreted with caution.
Keywords: NSCLC; efficacy; meta-analysis; osimertinib; safety; survival.