托西珠单抗治疗伴有恶病质的晚期非小细胞肺癌:观察性研究

IF 8.9 1区 医学 Journal of Cachexia, Sarcopenia and Muscle Pub Date : 2024-11-11 DOI:10.1002/jcsm.13638
Yang Du, Xiao‐Yan Liu, Rui‐Li Pan, Xiao‐Tong Zhang, Xiao‐Yan Si, Min‐Jiang Chen, Meng‐Zhao Wang, Li Zhang
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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; <jats:italic>p</jats:italic> &lt; 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; <jats:italic>p</jats:italic> &lt; 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, <jats:italic>p</jats:italic> = 0.041; albumin: 5.89 ± 0.70 g/L vs. −2.97 ± 0.71 g/L, <jats:italic>p</jats:italic> &lt; 0.001; CRP: −91.50 ± 7.15 mg/L vs. 9.47 ± 13.69 mg/L, <jats:italic>p</jats:italic> &lt; 0.001; mGPS: −1.61 ± 0.15 vs. 0.03 ± 0.08, <jats:italic>p</jats:italic> &lt; 0.001). The tocilizumab group also displayed significantly higher rates of improvement in appetite and fatigue (both <jats:italic>p</jats:italic> &lt; 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. 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引用次数: 0

摘要

背景癌症恶病质严重影响了非小细胞肺癌(NSCLC)患者的发病率和死亡率。由白细胞介素-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治疗合并IL-6升高恶病质的NSCLC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抗肿瘤治疗的合并IL-6升高恶病质的NSCLC患者的数据。主要终点是总生存期(OS)和第12周时改良格拉斯哥预后评分(mGPS)的改善。次要终点包括12周内体重、白蛋白、C反应蛋白(CRP)和mGPS与基线相比的变化。作为探索性分析,报告了患者自评的食欲和疲劳的定性改善情况。 结果该研究纳入了49名确诊为NSCLC和IL-6升高恶病质、东部合作肿瘤学组表现状态为2-4的患者。其中,26 名患者接受了托珠单抗与抗肿瘤疗法的联合治疗,23 名患者单独接受了抗肿瘤疗法。大部分患者为男性(87.8%)。两组患者的基线特征几乎相同。与对照组相比,托西珠单抗组的中位生存期明显更长(15.1 个月对 3.2 个月;危险比 0.18,95% 置信区间 0.08-0.38;p <0.001)。托西珠单抗组患者在第12周时mGPS改善的存活率明显高于对照组(风险差异为0.88,95%置信区间为0.75-1.00;p <0.001)。与对照组相比,在 12 周内,托西珠单抗组的体重、白蛋白、CRP 和 mGPS 均有显著改善(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:-0.03±0.08,p <0.001)。托西珠单抗组的食欲和疲劳改善率也明显更高(均为 p <0.001)。托西珠单抗组的3级或以上不良反应发生率为34.6%,而对照组为78.3%。3例患者(11.5%)出现了与托珠单抗相关的不良事件,包括2例中性粒细胞减少症和1例皮肤及皮下组织感染。结论托珠单抗对NSCLC和并发IL-6升高恶病质患者的生存期和各种临床指标,包括体重、白蛋白、CRP、mGPS和症状负担有显著疗效。鉴于目前对癌症恶病质有效干预的医疗需求尚未得到满足,托珠单抗可被视为一种潜在的治疗选择。
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Tocilizumab for Advanced Non‐Small‐Cell Lung Cancer With Concomitant Cachexia: An Observational Study
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.
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来源期刊
Journal of Cachexia, Sarcopenia and Muscle
Journal of Cachexia, Sarcopenia and Muscle Medicine-Orthopedics and Sports Medicine
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期刊介绍: The Journal of Cachexia, Sarcopenia, and Muscle is a prestigious, peer-reviewed international publication committed to disseminating research and clinical insights pertaining to cachexia, sarcopenia, body composition, and the physiological and pathophysiological alterations occurring throughout the lifespan and in various illnesses across the spectrum of life sciences. This journal serves as a valuable resource for physicians, biochemists, biologists, dieticians, pharmacologists, and students alike.
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