Department of Pharmacy, General Hospital of Yangtze River Shipping, Wuhan Bain Hospital, Wuhan, China.
Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Pak J Pharm Sci. 2023 Mar;36(2):365-372.
Our study aimed to evaluate the efficacy and toxicity of alectinib compared with crizotinib and provide a reference for clinical use of ALK-TKI, systematically. We searched articles published update till October, 2021 based on the electronic databases, including PubMed, EMBASE and Cochrane Library. All trials analyzed the summary odds ratios (ORs) of the interesting outcomes. Three RCTs, including six studies were included. The pooled hazard ratio (HR) =0.33 (95%CI=0.21-0.51, P<0.00001) shown that the alectinib group achieved significant progress-free survival (PFS) superiority than crizotinib, consistent with those for the with (P=0.001) or without (P<0.00001) measurable CNS lesions at baseline. Also, the regimen of the alectinib did achieved benefit in the ORR (OR=2.07, 95% CI=1.41-3.06, P=0.0002) than crizotinib. Due to the limited data, the pool result of the difference of overall survival (OS) was without statistically significant (P=0.35). With regard to the safety, grade 3 to 5 adverse events were less frequent with alectinib than crizotinib (OR=0.53, 95% CI=0.31-0.90, P=0.02). As compared with crizotinib, alectinib demonstrated better PFS efficacy and comparable safety as a first-line treatment for advanced ALK-positive Non-Small Cell Lung Cancer (NSCLC). OS data remain immature, further trials with long-term survival rate have future to look forward to.
我们的研究旨在评估阿来替尼与克唑替尼相比的疗效和毒性,并系统地为 ALK-TKI 的临床应用提供参考。我们根据电子数据库,包括 PubMed、EMBASE 和 Cochrane Library,检索了截至 2021 年 10 月更新的文章。所有试验均分析了感兴趣结局的汇总优势比(OR)。纳入了三项 RCT,共包括六项研究。汇总的风险比(HR)=0.33(95%CI=0.21-0.51,P<0.00001)表明,阿来替尼组的无进展生存期(PFS)显著优于克唑替尼,与基线时有无可测量的中枢神经系统病变(P=0.001)或基线时有可测量的中枢神经系统病变(P<0.00001)一致。此外,阿来替尼方案在客观缓解率(ORR)方面也有获益(OR=2.07,95%CI=1.41-3.06,P=0.0002)优于克唑替尼。由于数据有限,总生存期(OS)的汇总结果无统计学意义(P=0.35)。关于安全性,阿来替尼的 3 级至 5 级不良事件发生率低于克唑替尼(OR=0.53,95%CI=0.31-0.90,P=0.02)。与克唑替尼相比,阿来替尼作为晚期 ALK 阳性非小细胞肺癌(NSCLC)的一线治疗药物,具有更好的 PFS 疗效和相当的安全性。OS 数据仍不成熟,未来需要进一步的临床试验来观察长期生存率。