Zhou Jian-Xi, Sun Yun-Chuan, Xiao Li, Lu Hong-Ling, Yin Xiao-Ming, Fan Kui, Zhou Ying-Nan
Department of Radiation Oncology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine-Hebei Province, Cangzhou, 061000, Hebei, China.
Department of Radiotherapy and Chemotherapy, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine East Ward, Cangzhou, 061000, Hebei, China.
Sci Rep. 2025 Apr 16;15(1):13063. doi: 10.1038/s41598-025-98018-8.
Extensive-stage small cell lung cancer (ES-SCLC) is a highly aggressive subtype of lung cancer with limited treatment options and poor prognosis. In recent years, immune checkpoint inhibitors (ICIs) combined with chemotherapy have demonstrated significant efficacy in several clinical trials. This study aims to evaluate the efficacy of first-line chemotherapy combined with immunotherapy in patients with ES-SCLC and identify prognostic factors based on real-world data. This retrospective study analyzed the clinical data of 349 patients with ES-SCLC treated at Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine from January 2018 to August 2023. The patients were divided into a combination group (chemotherapy plus immunotherapy, n = 173) and a chemotherapy group (chemotherapy alone, n = 176) based on their treatment regimens. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoint was treatment-related adverse events. Kaplan-Meier survival analysis was performed, and Cox regression models were used to analyze the factors influencing OS and PFS. The median OS in the combination group was 14.9 months, significantly longer than 11.9 months in the chemotherapy group (P < 0.001). After applying Propensity Score Matching (PSM) to minimize selection bias, the survival advantage remained statistically significant. The 1-, 2-, and 3-year OS rates in the combination group were 62.4%, 42.8%, and 19.5%, respectively, compared to 50.2%, 20.8%, and 9.6% in the chemotherapy group. The median PFS in the combination group was 5.4 months, also significantly longer than the 3.8 months observed in the chemotherapy group (P < 0.001). Multivariate analysis identified chemotherapy alone, ECOG performance status, and number of metastatic sites as independent risk factors for poorer OS and PFS (P < 0.001). A separate analysis was conducted to evaluate the association between tumor response (CR/PR/SD/PD) and survival outcomes, which showed that patients with CR/PR had significantly better OS and PFS compared to those with SD/PD (P < 0.001). These findings reinforce the clinical importance of achieving tumor response. There were no significant differences in the incidence of adverse events between the two groups, with most adverse events being grade 1-2, and no grade 5 adverse events were reported. This study demonstrates that chemotherapy combined with immunotherapy significantly prolongs OS and PFS in patients with ES-SCLC without substantially increasing treatment-related adverse events. This combination therapy shows promising clinical value for improving long-term prognosis in ES-SCLC patients. Future studies should explore potential biomarkers to optimize individualized treatment strategies.
广泛期小细胞肺癌(ES-SCLC)是一种侵袭性很强的肺癌亚型,治疗选择有限且预后较差。近年来,免疫检查点抑制剂(ICIs)联合化疗在多项临床试验中已显示出显著疗效。本研究旨在评估一线化疗联合免疫治疗在ES-SCLC患者中的疗效,并基于真实世界数据确定预后因素。这项回顾性研究分析了2018年1月至2023年8月在沧州市中西医结合医院接受治疗的349例ES-SCLC患者的临床资料。根据治疗方案,将患者分为联合组(化疗加免疫治疗,n = 173)和化疗组(单纯化疗,n = 176)。主要终点为总生存期(OS)和无进展生存期(PFS),次要终点为治疗相关不良事件。进行了Kaplan-Meier生存分析,并使用Cox回归模型分析影响OS和PFS的因素。联合组的中位OS为14.9个月,显著长于化疗组的11.9个月(P < 0.001)。应用倾向评分匹配(PSM)以尽量减少选择偏倚后,生存优势在统计学上仍具有显著性。联合组的1年、2年和3年OS率分别为62.4%、42.8%和19.5%,而化疗组分别为50.2%、20.8%和9.6%。联合组的中位PFS为5.4个月,也显著长于化疗组观察到的3.8个月(P < 0.001)。多变量分析确定单纯化疗、东部肿瘤协作组(ECOG)体能状态和转移部位数量是OS和PFS较差的独立危险因素(P < 0.001)。进行了一项单独分析以评估肿瘤反应(完全缓解/部分缓解/疾病稳定/疾病进展)与生存结果之间的关联,结果显示,与疾病稳定/疾病进展的患者相比,完全缓解/部分缓解的患者的OS和PFS显著更好(P < 0.001)。这些发现强化了实现肿瘤反应的临床重要性。两组之间不良事件的发生率没有显著差异,大多数不良事件为1-2级,未报告5级不良事件。本研究表明,化疗联合免疫治疗可显著延长ES-SCLC患者的OS和PFS,且不会大幅增加治疗相关不良事件。这种联合治疗在改善ES-SCLC患者的长期预后方面显示出有前景的临床价值。未来的研究应探索潜在的生物标志物,以优化个体化治疗策略。