背景:小细胞肺癌(SCLC)是一种高度侵袭性的肿瘤,尽管努力开发新的治疗策略,但总生存期(OS)仍然很差.在第二行,托泊替康是唯一被批准的药物,中位OS为5.9个月。然而,与研究人群相比,现实世界中的SCLC患者通常情况更差,并有更多的合并症.因此,托泊替康的实际表现可能与研究中的不同。这里,我们分析了接受托泊替康治疗的SCLC患者的结局,并确定了预测和预后标志物.
方法:我们回顾性分析了2015年至2022年间接受托泊替康的44例连续SCLC患者。我们分析了基线特征(年龄,ECOG-PS,托泊替康循环,和剂量)和治疗前的血液值(LDH,CRP,钠)以及预后评分(中性粒细胞/淋巴细胞比率(NLR),血小板/淋巴细胞比率(TLR),格拉斯哥预后评分,预后营养评分,全身炎症指数(SII),和预后指数)从电子患者图中提取,以确定预测和预后标志物。
结果:在我们的队列中,mPFS和mOS分别只有1.9和5.6个月,分别。性别,ECOG-PS,活跃的脑转移,NLR,GPS,PNI,在单因素分析中,SII显著影响PFS和OS。ECOG-PS(p>0.001),活动性脑转移(p=0.001),在多变量COX回归模型中,SII(p=0.008)是显著的独立预后变量.通过这三种标志物选择患者实现5.7个月的mPFS,因此mPFS增加了三倍。不符合所有标准的患者的mPFS为1.8个月(p=0.006)。通过预后标志物鉴定的患者的mOS为9.1个月(p=0.002)。
结论:托泊替康在SCLC真实世界患者中的疗效较差,这表明许多患者没有任何获益。易于获得的标志物可以预测反应和治疗效果,因此应在更大的队列中进行验证,以确定更有可能从托泊替康中受益的患者。
BACKGROUND: Small-cell lung cancer (SCLC) is a highly aggressive tumor, and overall survival (OS) remains poor despite intensive efforts to develop new treatment strategies. In second line, topotecan is the only approved drug, with a median OS of 5.9 months. However, real-world SCLC patients are often in worse condition and harbor more comorbidities than study populations. Therefore, the real-world performance of topotecan may differ from that seen in studies. Here, we analyzed outcomes of SCLC patients receiving topotecan and identified predictive and prognostic markers.
METHODS: We retrospectively analyzed 44 consecutive SCLC patients receiving topotecan between 2015 and 2022. We analyzed baseline characteristics (age, ECOG-PS, topotecan cycles, and dosage) and pre-treatment blood values (LDH, CRP, sodium) as well as prognostic scores (neutrophil/lymphocyte ratio (NLR), thrombocyte/lymphocyte ratio (TLR), Glasgow Prognostic Score, prognostic nutritional score, systemic inflammation index (SII), and the prognostic index) extracted from electronic patients\' charts to identify predictive and prognostic markers.
RESULTS: In our cohort, mPFS and mOS were only 1.9 and 5.6 months, respectively. Gender, ECOG-PS, active brain metastases, NLR, GPS, PNI, and SII significantly influenced PFS and OS in univariate analysis. ECOG-PS (p > 0.001), active brain metastases (p = 0.001), and SII (p = 0.008) were significant independent prognostic variables in a multivariate COX regression model. Selecting patients by these three markers achieved an mPFS of 5.7 months and thus increased the mPFS three-fold. Patients not meeting all criteria had an mPFS of 1.8 months (p = 0.006). Patients identified by prognostic markers had an mOS of 9.1 months (p = 0.002).
CONCLUSIONS: The efficacy of topotecan in SCLC real-world patients is poor, indicating that many patients were treated without any benefit. Easy-to-obtain markers can predict response and treatment efficacy and should therefore be validated in larger cohorts to identify patients who are more likely to benefit from topotecan.