免疫疗法在经治的晚期非小细胞肺癌患者中的实际疗效

4  April 2022

Real-World Effectiveness of Immunotherapies in Pre-Treated, Advanced Non-Small Cell Lung Cancer Patients: A Systematic Literature Review

Juarez-Garcia A, Sharma R, Hunger M, Kayaniyil S, Penrod JR, Chouaïd C. Real-world effectiveness of immunotherapies in pre-treated, advanced non-small cell lung cancer Patients: A systematic literature review. Lung Cancer. 2022 Mar 9;166:205-220. 

Corresponding author:Christos Chouaïd, MD, PhD、Centre Hospitalier Intercommunal (CHI) Créteil,Créteil, France、Email: christos.chouaid@chicreteil.fr

Background 背景

Clinical trials have shown immunotherapy (IO) to be more effective than chemotherapy in pre-treated, advanced non-small cell lung cancer (NSCLC). However, there is a lack of understanding of its effectiveness in clinical practice, and among patient groups that are often underrepresented in trials. We aimed to summarize the existing real-world evidence (RWE) on the survival outcomes of IO in second- or higher line in advanced NSCLC.

临床试验表明，免疫疗法（IO）在经治的晚期非小细胞肺癌（NSCLC）中比化疗更有效。然而，人们对其在临床实践中的有效性缺乏了解，对在试验中代表性不足的患者群体中往往也缺乏了解。我们旨在总结，关于晚期非小细胞肺癌二线或二线以上患者IO生存结果的真实世界证据（RWE）。

Methods 方法

We conducted a systematic review of real-world observational studies that reported overall survival (OS) estimates with IO, primarily nivolumab, pembrolizumab or atezolizumab, in adult, previously treated advanced or recurrent NSCLC patients. Metaanalysis was conducted using random-effect models to pool 1- and 2-year OS rates across studies. Additional subgroups were examined among patients treated with IO, including the elderly, those with poor performance status (PS) and those exhibiting metastasis.

我们对真实世界的观察性研究进行了系统回顾，这些研究报告了使用IO（主要是纳武利尤单抗、帕博利珠单抗或阿替利珠单抗）对成年、经治的晚期或复发性NSCLC患者的总生存率（OS）进行估计。采用随机效应模型进行元分析，以汇总研究中的1年和2年OS率。在接受IO治疗的患者中检查了其他亚组，包括老年人、体能表现不佳（PS）的患者和表现出转移的患者。

Results 结果

In total, 66 studies were included, of which 46 (70%) included a nivolumab-specific study arm. Pooled 1-year and 2-year OS rates with nivolumab monotherapy were 45.6% (95% CI; 43.4-47.8) and 28.0% (95% CI; 24.8-31.4), respectively, compared to 43.9% (95% CI; 39.1-48.8) and 20.4% (95% CI; 14.7-27.6) in the mixed immune checkpoint inhibitors (ICI) group. OS rates with nivolumab were slightly lower in elderly compared to non-elderly populations. Poor PS was associated with worse survival rates, with a pooled one-year OS estimate of 27.1% in PS≥2 vs 51.6% in PS<2. The pooled 2-year OS rate with nivolumab in patients with and without brain metastases was 22.1% and 26.1% respectively, and this difference was significant in 36% of individual studies.

总共包括66项研究，其中46项（70%）囊括了纳武利尤单抗特异性研究组。与混合免疫检查点抑制剂（ICI）组的43.9%（95% CI；39.1-48.8）和20.4%（95% CI；14.7-27.6）相比，使用纳武利尤单抗单药治疗的一年和两年总生存率分别为45.6%（95% CI；43.4-47.8）和28.0%（95% CI；24.8-31.4）。老年人使用纳武利尤单抗的总生存率略低于非老年人。较差的PS评分与较差的生存率相关，预估一年汇总总生存率在PS评分≥2的人群中是27.1%，在PS评分<2的人群中是51.6%。在有脑转移和无脑转移的患者中，使用纳武利尤单抗的汇总两年总生存率分别为22.1%和26.1%，这种差异在36%的个体研究中比较显著。

Conclusions 结论

While the OS benefits of IO seen in real-world studies among pre-treated, advanced NSCLC patients are consistent with pivotal clinical trials, these tend to vary for the more vulnerable patient groups, such as patients with poor PS, which are often excluded from trials. Further research is needed to investigate findings in patients with brain and liver metastases.

虽然在经治的晚期非小细胞肺癌患者的真实研究中观察到IO的OS获益与关键临床试验一致，但对于更脆弱的患者群体，例如PS评分不佳的患者，这些获益往往不尽如人意，因为这些患者往往被排除在试验之外。需要进一步的研究来探讨对于脑和肝转移患者的发现。

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