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免疫检查点抑制剂治疗晚期非小细胞肺癌的受限平均生存时间

Restricted mean survival time in advanced non-small cell lung cancer treated with immune checkpoint inhibitors.

作者信息

Di Spazio L, Cancanelli L, Rivano M, Chiumente M, Mengato D, Messori A

机构信息

Hospital Pharmacy Department, S. Chiara Hospital, Trento, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2021 Feb;25(4):1881-1889. doi: 10.26355/eurrev_202102_25083.

Abstract

OBJECTIVE

The purpose of this study was to review the effectiveness of immune checkpoint inhibitors (ICIs) in the first-line treatment of advanced non-small cell lung carcinoma with wild-type epidermal grow factor receptor (EGFR) or anaplastic lymphoma kinase.

MATERIALS AND METHODS

After a standard literature search, we identified all randomized studies published on this issue. Our first inclusion criterion was the use of pembrolizumab, nivolumab, atezolizumab or durvalumab in the treatment arm versus chemotherapy in the control arm. The second criterion was the availability of information on overall survival at 2 years. The restricted mean survival time (RMST) was used to analyze the survival curves and rank the treatments.

RESULTS

From the eligible studies, we selected 5 randomized trials that met our inclusion criteria. These trials studied a total of 11 cohorts of patients in whom the treatment arm received ICI as monotherapy (n=3) or in combination with either chemotherapy (n=2) or other monoclonal antibodies (n=1). All the control groups (n=5) received chemotherapy. Pembrolizumab (alone or in combination) showed improvement in overall survival compared with controls, but with borderline statistical significance. Nivolumab, atezolizumab and durvalumab failed to demonstrate any survival advantage. Overall, the RMSTs provided more conservative results than those previously reported using the hazard ratio. In comparing the values of RMST across treatments, pembrolizumab combined with chemotherapy ranked first.

CONCLUSIONS

Our results summarized the efficacy of these treatments and showed that only pembrolizumab can have a role as the first-line treatment of NSCLC. These findings are at variance with those previously reported using the hazard ratio as the outcome measure.

摘要

目的

本研究旨在回顾免疫检查点抑制剂(ICI)在一线治疗野生型表皮生长因子受体(EGFR)或间变性淋巴瘤激酶的晚期非小细胞肺癌中的有效性。

材料与方法

在进行标准文献检索后,我们确定了所有关于此问题发表的随机研究。我们的首要纳入标准是治疗组使用派姆单抗、纳武单抗、阿特珠单抗或度伐鲁单抗,对照组使用化疗。第二个标准是有2年总生存信息。使用受限平均生存时间(RMST)来分析生存曲线并对治疗进行排名。

结果

从符合条件的研究中,我们选择了5项符合我们纳入标准的随机试验。这些试验共研究了11组患者,其中治疗组接受ICI单药治疗(n = 3)或与化疗联合(n = 2)或与其他单克隆抗体联合(n = 1)。所有对照组(n = 5)接受化疗。与对照组相比,派姆单抗(单独或联合使用)显示总生存有所改善,但具有临界统计学意义。纳武单抗、阿特珠单抗和度伐鲁单抗未能显示出任何生存优势。总体而言,RMST提供的结果比先前使用风险比报告的结果更保守。在比较各治疗的RMST值时,派姆单抗联合化疗排名第一。

结论

我们的结果总结了这些治疗的疗效,表明只有派姆单抗可作为非小细胞肺癌的一线治疗。这些发现与先前使用风险比作为结局指标报告的结果不同。

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