BackgroundCancer cachexia significantly contributes to morbidity and mortality in patients with non‐small‐cell lung cancer (NSCLC). Inflammatory pathways mediated by interleukin‐6 (IL‐6) play a crucial role in the development of cancer cachexia. This study aimed to investigate the use of tocilizumab in the management of NSCLC with coexisting IL‐6‐elevated cachexia.MethodsIn this retrospective study, data were collected from patients with NSCLC and concurrent IL‐6‐elevated cachexia who received either tocilizumab plus antitumour therapy or antitumour therapy alone. The primary endpoints were overall survival (OS) and improved modified Glasgow Prognostic Score (mGPS) at Week 12. The secondary endpoints included changes from baseline over 12 weeks in body weight, albumin, C‐reactive protein (CRP) and mGPS. Qualitative improvements in patient self‐rated appetite and fatigue were reported as exploratory analysis.ResultsThe study included 49 patients diagnosed with NSCLC and IL‐6‐elevated cachexia, Eastern Cooperative Oncology Group performance status of 2–4. Of these, 26 received tocilizumab in combination with antitumour therapy, and 23 received antitumour therapy alone. The majority of these patients were male (87.8%). Baseline characteristics were almost identical between the two groups. The tocilizumab group demonstrated a significantly longer median OS compared to the control group (15.1 vs. 3.2 months; hazard ratio 0.18, 95% confidence interval 0.08–0.38; p < 0.001). The rate of patients surviving with mGPS improvement at Week 12 was significantly higher in the tocilizumab group than in the control group (risk difference 0.88, 95% confidence interval 0.75–1.00; p < 0.001). Over the 12‐week period, significant improvements were observed in body weight, albumin, CRP and mGPS in the tocilizumab group compared to the control group (body weight: 5.15 ± 0.53 kg vs. −5.69 ± 0.76 kg, p = 0.041; albumin: 5.89 ± 0.70 g/L vs. −2.97 ± 0.71 g/L, p < 0.001; CRP: −91.50 ± 7.15 mg/L vs. 9.47 ± 13.69 mg/L, p < 0.001; mGPS: −1.61 ± 0.15 vs. 0.03 ± 0.08, p < 0.001). The tocilizumab group also displayed significantly higher rates of improvement in appetite and fatigue (both p < 0.001). The incidence of Grade 3 or higher adverse events was 34.6% in the tocilizumab group compared to 78.3% in the control group. Tocilizumab‐related adverse events were observed in three patients (11.5%), including two cases of neutropenia and one case of skin and subcutaneous tissue infection.ConclusionTocilizumab demonstrated significant benefits in survival and various clinical parameters, including body weight, albumin, CRP, mGPS and symptom burden in patients with NSCLC and concurrent IL‐6‐elevated cachexia. Given the existing unmet medical need for effective interventions for cancer cachexia, tocilizumab may be considered as a potential treatment option.

中文翻译：

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托珠单抗治疗伴有恶病质的晚期非小细胞肺癌：一项观察性研究


背景癌症恶病质显着导致非小细胞肺癌 （NSCLC） 患者的发病率和死亡率。白细胞介素 6 （IL-6） 介导的炎症通路在癌症恶病质的发展中起着至关重要的作用。本研究旨在探讨托珠单抗在合并 IL-6 升高恶病质的 NSCLC 治疗中的应用。方法在这项回顾性研究中，收集了接受托珠单抗联合抗肿瘤治疗或单独接受抗肿瘤治疗的 NSCLC 合并并发 IL-6 升高恶病质的患者的数据。主要终点是第 12 周的总生存期 （OS） 和改良的格拉斯哥预后评分 （mGPS） 改善。次要终点包括 12 周内体重、白蛋白、C 反应蛋白 （CRP） 和 mGPS 相对于基线的变化。患者自评食欲和疲劳的定性改善作为探索性分析报告。结果该研究包括 49 例诊断为 NSCLC 和 IL-6 升高恶病质的患者，Eastern Cooperative Oncology Group 体能状态为 2-4。其中，26 例接受托珠单抗联合抗肿瘤治疗，23 例接受单独抗肿瘤治疗。这些患者中大多数为男性 （87.8%）。两组之间的基线特征几乎相同。与对照组相比，托珠单抗组的中位 OS 显著延长 （15.1 vs. 3.2 个月;风险比 0.18,95% 置信区间 0.08-0.38;p < 0.001）。托珠单抗组第 12 周 mGPS 改善患者的存活率显著高于对照组 （风险差 0.88,95% 置信区间 0.75-1.00;p < 0.001）。 在 12 周内，与对照组相比，托珠单抗组的体重、白蛋白、CRP 和 mGPS 观察到显着改善（体重：5.15 ± 0.53 kg vs. -5.69 ± 0.76 kg，p = 0.041;白蛋白：5.89 ± 0.70 g/L vs. -2.97 ± 0.71 g/L，p < 0.001;CRP：-91.50 ± 7.15 mg/L vs. 9.47 ± 13.69 mg/L，p < 0.001;mGPS：-1.61 ± 0.15 对 0.03 ± 0.08，p < 0.001）。托珠单抗组的食欲和疲劳改善率也显着升高 （均 p < 0.001）。托珠单抗组 3 级或更高级别不良事件的发生率为 34.6%，而对照组为 78.3%。在 3 例患者 （11.5%） 中观察到托珠单抗相关不良事件，包括 2 例中性粒细胞减少症和 1 例皮肤和皮下组织感染。结论托珠单抗在生存率和各种临床参数（包括体重、白蛋白、CRP、mGPS 和症状负担）方面显示出显著益处 NSCLC 合并 IL-6 升高恶病质患者。鉴于目前对癌症恶病质有效干预的医疗需求未得到满足，托珠单抗可能被视为一种潜在的治疗选择。