Chen Peng, Chen Fuchao, Lei Jiexin, Zhou Benhong
Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China,
Department of Pharmacy, Dongfeng Hospital, Hubei University of Medicine, Shiyan, Hubei 442008, People's Republic of China.
Onco Targets Ther. 2018 Dec 12;11:9033-9047. doi: 10.2147/OTT.S182077. eCollection 2018.
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.
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.
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, =0.14), DCR (combined RR=1.07, 95% CI: 0.79-1.44, =0.66), PFS (combined RR=0.32, 95% CI: 0.24-0.44, <0.00001), and OS (combined RR=0.57, 95% CI: 0.47-0.70, <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).
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.
奥希替尼是一种表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），对非小细胞肺癌（NSCLC）患者的EGFR-TKI敏感突变和T790M耐药突变均具有选择性。本研究的目的是进行一项荟萃分析，以评估奥希替尼治疗NSCLC的临床疗效和安全性。
以“奥希替尼”为关键词，结合“非小细胞肺癌”和“随机对照试验”作为医学主题词，检索以下电子数据库：PubMed、EMBASE、Cochrane图书馆和中国知网。在对纳入的随机对照试验进行数据提取和质量评估后，应用RevMan 5.3软件和R语言的meta包对客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性进行荟萃分析。
10项研究符合纳入标准并被纳入荟萃分析，共有3260名参与者。荟萃分析表明，奥希替尼治疗在ORR（合并RR=1.53，95%CI：0.87-2.71，P=0.14）、DCR（合并RR=1.07，95%CI：0.79-1.44，P=0.66）、PFS（合并RR=0.32，95%CI：0.24-0.44，P<0.00001）和OS（合并RR=0.57，95%CI：0.47-0.70，P<0.00001）方面优于单纯对照治疗。此外，奥希替尼会导致一些毒性反应，所有级别腹泻的总体发生率为40%（95%CI：33-47），甲沟炎为26%（95%CI：20-33），皮疹为40%（95%CI：34-47），皮肤干燥为28%（95%CI：23-33），口腔炎为15%（95%CI：9-23）。
我们的研究表明，奥希替尼在NSCLC患者的ORR、DCR、PFS和OS方面有显著改善，且不良反应可耐受。然而，由于存在一些明显的局限性（异质性和发表偏倚），这些结果应谨慎解读。
