Immunotherapy with PD-1/PD-L1 inhibitors has significantly improved the survival rates of patients with metastatic non-small-cell lung cancer (NSCLC). Results of a real-world data study investigating add-on VA (Viscum albumL.) to chemotherapy have shown an association with the improved overall survival of patients with NSCLC. We sought to investigate whether the addition of VA to PD-1/PD-L1 inhibitors in patients with advanced or metastasised NSCLC would have an additional survival benefit. In the present real-world data study, we enrolled patients from the accredited national registry, Network Oncology, with advanced or metastasised NSCLC. The reporting of data was performed in accordance with the ESMO-GROW criteria for the optimal reporting of oncological real-world evidence (RWE) studies. Overall survival was compared between patients receiving PD-1/PD-L1 inhibitor therapy (control, CTRL group) versus the combination of anti-PD-1/PD-L1 therapy and VA (combination, COMB group). An adjusted multivariate Cox proportional hazard analysis was performed to investigate variables associated with survival. From 31 July 2015 to 9 May 2023, 415 patients with a median age of 68 years and a male/female ratio of 1.2 were treated with anti-PD-1/PD-L1 therapy with or without add-on VA. Survival analyses included 222 (53.5%) patients within the CRTL group and 193 (46.5%) in the COMB group. Patients in the COMB group revealed a median survival of 13.8 months and patients in the CRTL group a median survival of 6.8 months (adjusted hazard ratio, aHR: 0.60, 95% CI: 0.43–0.85,p= 0.004) after adjustment for age, gender, tumour stage, BMI, ECOG status, oncological treatment, and PD-L1 tumour proportion score. A reduction in the adjusted hazard of death by 56% was seen with the addition of VA (aHR 0.44, 95% CI: 0.26–0.74,p= 0.002) in patients with PD-L1-positive tumours (tumour proportion score > 1%) treated with first-line anti-PD-1/PD-L1 therapy. Our findings suggest that add-on VA correlates with improved survival in patients with advanced or metastasised NSCLC who were treated with PD-1/PD-L1 inhibitors irrespective of age, gender, tumour stage, or oncological treatment. The underlying mechanisms may include the synergistic modulation of the immune response. A limitation of this study is the observational non-randomised study design, which only allows limited conclusions to be drawn and prospective randomised trials are warranted.
PD-1/PD-L1抑制剂免疫疗法显著提高了转移性非小细胞肺癌（NSCLC）患者的生存率。一项真实世界数据研究显示，在化疗基础上加用白槲寄生（Viscum album L., VA）与NSCLC患者总生存期的改善相关。本研究旨在探讨在晚期或转移性NSCLC患者中，在PD-1/PD-L1抑制剂治疗基础上加用VA是否能带来额外的生存获益。本项真实世界数据研究从国家认证的肿瘤网络登记系统（Network Oncology）中纳入晚期或转移性NSCLC患者。数据报告遵循ESMO-GROW标准，以实现肿瘤学真实世界证据研究的最佳报告。研究比较了接受PD-1/PD-L1抑制剂单药治疗（对照组，CTRL组）与接受抗PD-1/PD-L1治疗联合VA（联合组，COMB组）患者的总生存期。采用调整后的多变量Cox比例风险模型分析与生存相关的变量。 自2015年7月31日至2023年5月9日，共有415例中位年龄68岁、男女比例为1.2的患者接受了抗PD-1/PD-L1治疗，其中部分患者联合使用了VA。生存分析包括CTRL组222例（53.5%）患者和COMB组193例（46.5%）患者。在对年龄、性别、肿瘤分期、体重指数（BMI）、ECOG体能状态、肿瘤治疗方案及PD-L1肿瘤比例评分进行调整后，COMB组患者的中位生存期为13.8个月，CTRL组为6.8个月（调整后风险比，aHR：0.60，95% CI：0.43–0.85，p=0.004）。在接受一线抗PD-1/PD-L1治疗的PD-L1阳性肿瘤（肿瘤比例评分>1%）患者中，加用VA可使调整后的死亡风险降低56%（aHR 0.44，95% CI：0.26–0.74，p=0.002）。 我们的研究结果表明，在接受PD-1/PD-L1抑制剂治疗的晚期或转移性NSCLC患者中，无论年龄、性别、肿瘤分期或肿瘤治疗方案如何，加用VA与生存期改善相关。其潜在机制可能包括对免疫反应的协同调节作用。本研究的局限性在于其为观察性非随机研究设计，仅能得出有限结论，仍需开展前瞻性随机试验加以验证。
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