Thronicke Anja, Grabowski Patricia, Roos Juliane, Wüstefeld Hannah, Grah Christian, Johnson Sophia, Schad Friedemann
Network Oncology Registry, Research Institute Havelhöhe, Kladower Damm 221, 14089 Berlin, Germany.
Interdisciplinary Oncological Centre, Hospital Havelhöhe, Kladower Damm 221, 14089 Berlin, Germany.
Int J Mol Sci. 2025 Apr 12;26(8):3669. doi: 10.3390/ijms26083669.
Real-world data (RWD) play a crucial role in identifying key subgroups and assessing multimodal oncology therapies, including integrative and palliative care. Immune checkpoint blockade (ICB) has improved survival, and its combination with complementary therapies like L. extracts (VA) may enhance outcomes. This RWD study, based on the Network Oncology registry and ESMO-GROW guidelines, analyzed oncological patients receiving PD-1/PD-L1 inhibitors alone or with Helixor VA (HVA) extracts. Primary and secondary objectives were tolerability and overall survival. Statistical analyses included Kaplan-Meier survival curves and Cox regression. Among 405 cancer patients, 344 received ICB alone (CTRL) and 61 received ICB + HVA (COMB). Lung cancer was predominant (78.6%). Adverse event-related discontinuation was lower in COMB (4.9% vs. 6.4%, = 0.25). In non-small cell lung cancer (NSCLC) patients, the 3-year survival rate was significantly higher in COMB (34.3% vs. 17.2%, = 0.02). In female NSCLC patients, COMB was significantly associated with a reduced death risk of 91.2% (aHR: 0.088; 95% CI: 0.009-0.783). Our RWD findings show the favorable tolerability of combinatorial ICB + HVA in several tumor entities and underscore its potential to improve survival in NSCLC particularly in female NSCLC patients, warranting further investigation.
真实世界数据（RWD）在识别关键亚组和评估多模式肿瘤治疗（包括综合治疗和姑息治疗）中起着至关重要的作用。免疫检查点阻断（ICB）已提高了生存率，其与诸如L.提取物（VA）等补充疗法联合使用可能会改善治疗效果。这项基于网络肿瘤登记处和ESMO-GROW指南的真实世界数据研究分析了单独接受PD-1/PD-L1抑制剂或联合Helixor VA（HVA）提取物治疗的肿瘤患者。主要和次要目标是耐受性和总生存期。统计分析包括Kaplan-Meier生存曲线和Cox回归。在405例癌症患者中，344例单独接受ICB（对照组），61例接受ICB + HVA（联合组）。肺癌占主导（78.6%）。联合组中与不良事件相关的停药率较低（4.9%对6.4%，P = 0.25）。在非小细胞肺癌（NSCLC）患者中，联合组的3年生存率显著更高（34.3%对17.2%，P = 0.02）。在女性NSCLC患者中，联合组与死亡风险降低91.2%显著相关（调整后风险比：0.088；95%置信区间：0.009 - 0.783）。我们的真实世界数据研究结果表明，联合ICB + HVA在多个肿瘤实体中具有良好的耐受性，并强调了其改善NSCLC尤其是女性NSCLC患者生存率的潜力，值得进一步研究。
