Department of Respiratory Diseases, University Hospital Brno, Brno, Czech Republic.
Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Thorac Cancer. 2020 Nov;11(11):3346-3356. doi: 10.1111/1759-7714.13679. Epub 2020 Oct 5.
Data regarding real-life effectiveness of any treatment may improve clinical decision-making. The aim of this study was to evaluate real-life effectiveness of tyrosin-kinase inhibitors, bevacizumab and pemetrexed as first-line treatments in patients with advanced/metastatic non-small cell lung cancer (NSCLC).
We analyzed data of 2157 patients of the Czech TULUNG Registry of patients with advanced/metastatic NSCLC who received modern-era treatments between 2011 and 2018. Patients treated with gefitinib, erlotinib, afatinib, bevacizumab (+ maintenance), pemetrexed (+ maintenance) as first-line therapy were included in the study. A systematic literature search separately identified clinical trials suitable for calculation of comparator pooled OS and PFS for each regimen. For each subgroup, basic characteristics and survival data (Kaplan-Meier estimates) are shown. We propose the "index of real-life effectiveness" (IRE), a ratio of real-life OS/PFS and comparator pooled OS/PFS. Univariate and multivariate logistic regression identified factors were associated with longer OS (ie, IRE>1.1).
Survival analysis showed median OS of 23 months for erlotinib, 29.3 months for afatinib, 19.6 months for gefitinib, 12.2 months for pemetrexed, 17.5 months for pemetrexed maintenance, 15.8 months for bevacizumab and 15.8 months for bevacizumab maintenance. Calculated IREs for OS for the regimens were: erlotinib 1.013, afatinib 1.184, gefitinib 0.736, pemetrexed 1.188, pemetrexed maintenance 1.294, bevacizumab 1.178, and bevacizumab maintenance 1.189. Multivariate regression analysis showed that these factors were associated with longer OS: lower PS for afatinib; lower PS, absence of adverse events and female sex for bevacizumab; and lower PS and female sex for pemetrexed.
This study clearly demonstrated that real-life effectiveness of certain treatment regimens may strongly differ in various populations/health care systems, and comparison between TULUNG data and pooled survival data from trials showed higher real-life effectiveness for most of the studied first-line regimens. Lower ECOG PS, younger age, female sex and adverse events were associated with longer survival in most regimens.
SIGNIFICANT FINDINGS OF THE STUDY: Comparison between TULUNG data and pooled survival data from trials showed higher real-life effectiveness for most of the studied first-line regimens; for most regimens, lower ECOG PS, younger age, female sex and adverse events were associated with longer survival.
Real-life effectiveness of certain treatment regimens may strongly differ in various populations/health care systems.
任何治疗方法的实际效果数据可能会改善临床决策。本研究旨在评估酪氨酸激酶抑制剂、贝伐珠单抗和培美曲塞作为晚期/转移性非小细胞肺癌（NSCLC）患者一线治疗的实际效果。
我们分析了捷克 TULUNG 登记处 2157 名晚期/转移性 NSCLC 患者的数据，这些患者在 2011 年至 2018 年期间接受了现代治疗。接受吉非替尼、厄洛替尼、阿法替尼、贝伐珠单抗（维持治疗）、培美曲塞（维持治疗）作为一线治疗的患者纳入研究。单独进行系统文献检索，以确定适合计算每种方案的比较器汇总 OS 和 PFS 的临床试验。对于每个亚组，显示基本特征和生存数据（Kaplan-Meier 估计）。我们提出了“实际效果指数”（IRE），即实际 OS/PFS 与比较器汇总 OS/PFS 的比值。单变量和多变量逻辑回归确定了与更长 OS 相关的因素（即 IRE>1.1）。
生存分析显示厄洛替尼的中位 OS 为 23 个月，阿法替尼为 29.3 个月，吉非替尼为 19.6 个月，培美曲塞为 12.2 个月，培美曲塞维持治疗为 17.5 个月，贝伐珠单抗为 15.8 个月，贝伐珠单抗维持治疗为 15.8 个月。计算出的 OS 治疗方案的 IRE 分别为：厄洛替尼 1.013、阿法替尼 1.184、吉非替尼 0.736、培美曲塞 1.188、培美曲塞维持治疗 1.294、贝伐珠单抗 1.178 和贝伐珠单抗维持治疗 1.189。多变量回归分析表明，这些因素与更长的 OS 相关：阿法替尼的 PS 较低；贝伐珠单抗的 PS 较低、无不良事件和女性；培美曲塞的 PS 较低和女性。
本研究清楚地表明，某些治疗方案的实际效果在不同人群/医疗保健系统中可能存在很大差异，并且 TULUNG 数据与试验汇总生存数据之间的比较表明，大多数研究的一线治疗方案的实际效果更高。大多数方案中，ECOG PS 较低、年龄较小、女性和不良事件与更长的生存时间相关。
研究的重要发现：与试验的汇总生存数据相比，TULUNG 数据显示大多数研究的一线治疗方案的实际效果更高；对于大多数方案，ECOG PS 较低、年龄较小、女性和不良事件与更长的生存时间相关。
某些治疗方案的实际效果在不同人群/医疗保健系统中可能存在很大差异。
