Department of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita City, Osaka, 565-0871, Japan.
Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.
Target Oncol. 2024 Sep;19(5):757-767. doi: 10.1007/s11523-024-01084-7. Epub 2024 Jul 11.
Chemoimmunotherapy is a standard treatment for advanced non-small-cell lung cancer (NSCLC). However, data on clinical predictive factors remain scarce.
We aim to identify clinical biomarkers in patients undergoing chemoimmunotherapy.
This multicenter, real-world cohort study included chemonaive patients who underwent chemoimmunotherapy between December 2018 and May 2022. Multivariate analysis was used to determine associations between survival outcomes and patient background, including baseline neutrophil-to-lymphocyte ratio (NLR) and its dynamic change (ΔNLR). To further investigate the clinical significance of NLR, patients were classified based on their peripheral immune status, defined by a combination of NLR and ΔNLR.
The study included 280 patients with 30.1 months of median follow-up. Multivariate analysis revealed that older individuals, poor performance status, tumor proportion score < 1%, liver metastasis, baseline NLR ≥ 5, and ΔNLR ≥ 0 independently correlated significantly with shorter progression-free and overall survival (OS). Patients with high peripheral immune status (defined as NLR <5 and ΔNLR < 0) significantly improved long-term survival (2-year OS rate of 58.3%), whereas those with low peripheral immune status (defined as NLR ≥ 5 and ΔNLR ≥ 0) had extremely poor outcomes (2-year OS rate of 5.6%). Safety profiles did not differ significantly in terms of severe adverse events and treatment-related death rates despite the patients' peripheral immune status (P = 0.46 and 0.63, respectively).
Our study provides real-world evidence regarding clinical prognostic factors for the efficacy of chemoimmunotherapy. The combined assessment of baseline NLR and ΔNLR could facilitate the identification of patients who are likely to achieve a durable response from chemoimmunotherapy.
化疗免疫治疗是晚期非小细胞肺癌（NSCLC）的标准治疗方法。然而，关于临床预测因素的数据仍然很少。
我们旨在确定接受化疗免疫治疗的患者的临床生物标志物。
这项多中心、真实世界的队列研究纳入了 2018 年 12 月至 2022 年 5 月期间接受化疗免疫治疗的化疗初治患者。采用多变量分析确定生存结果与患者背景之间的关联，包括基线中性粒细胞与淋巴细胞比值（NLR）及其动态变化（ΔNLR）。为了进一步研究 NLR 的临床意义，根据 NLR 和 ΔNLR 的组合定义患者的外周免疫状态，将患者进行分类。
该研究纳入了 280 例患者，中位随访时间为 30.1 个月。多变量分析显示，年龄较大、体力状态差、肿瘤比例评分<1%、肝转移、基线 NLR≥5 和 ΔNLR≥0 与无进展生存期和总生存期（OS）较短显著相关。外周免疫状态高的患者（定义为 NLR<5 和 ΔNLR<0）显著改善了长期生存（2 年 OS 率为 58.3%），而外周免疫状态低的患者（定义为 NLR≥5 和 ΔNLR≥0）则预后极差（2 年 OS 率为 5.6%）。尽管患者的外周免疫状态不同，但严重不良事件和治疗相关死亡率的发生率无显著差异（分别为 P=0.46 和 0.63）。
本研究提供了化疗免疫治疗疗效的临床预后因素的真实世界证据。基线 NLR 和 ΔNLR 的联合评估有助于识别可能从化疗免疫治疗中获得持久反应的患者。
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