单臂试验与真实世界数据的疗效比较：阿来替尼对比色瑞替尼。
Comparative effectiveness from a single-arm trial and real-world data: alectinib versus ceritinib.
作者信息
Davies Jessica, Martinec Michael, Delmar Paul, Coudert Mathieu, Bordogna Walter, Golding Sophie, Martina Reynaldo, Crane Gracy
机构信息
Roche Products Ltd, 6 Flacon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK.
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
出版信息
J Comp Eff Res. 2018 Sep;7(9):855-865. doi: 10.2217/cer-2018-0032. Epub 2018 Jun 26.
AIM
To compare the overall survival of anaplastic lymphoma kinase-positive non-small-cell lung cancer patients who received alectinib with those who received ceritinib.
MATERIALS & METHODS: Two treatment arms (alectinib [n = 183] and ceritinib [n = 67]) were extracted from clinical trials and an electronic health record database, respectively. Propensity scores were applied to balance baseline characteristics. Kaplan-Meier and multivariate Cox regression were conducted.
RESULTS
After propensity score adjustment, baseline characteristics were balanced. Alectinib had a prolonged median overall survival (alectinib = 24.3 months and ceritinib = 15.6 months) and lower risk of death (hazard ratio: 0.65; 95% CI: 0.48-0.88).
CONCLUSION
Alectinib was associated with prolonged overall survival versus ceritinib, which is consistent with efficacy evidence from clinical trials.
目的
比较接受阿来替尼治疗的间变性淋巴瘤激酶阳性非小细胞肺癌患者与接受色瑞替尼治疗的患者的总生存期。
材料与方法
分别从临床试验和电子健康记录数据库中提取两个治疗组（阿来替尼组[n = 183]和色瑞替尼组[n = 67]）。应用倾向评分来平衡基线特征。进行了Kaplan-Meier分析和多变量Cox回归分析。
结果
经过倾向评分调整后，基线特征得到平衡。阿来替尼组的中位总生存期延长（阿来替尼组=24.3个月，色瑞替尼组=15.6个月），死亡风险较低（风险比：0.65；95%置信区间：0.48-0.88）。
结论
与色瑞替尼相比，阿来替尼可延长总生存期，这与临床试验的疗效证据一致。
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