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免疫检查点抑制剂联合化疗在台湾广泛期小细胞肺癌患者中的真实世界有效性和安全性

Real-World Effectiveness and Safety of Immune Checkpoint Inhibitors Combined with Chemotherapy in Taiwanese Patients with Extensive-Stage Small Cell Lung Cancer.

作者信息

Chang Cheng-Yu, Wei Yu-Feng, Chang Shih-Chieh, Chen Chung-Yu

机构信息

Division of Chest Medicine, Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City 220216, Taiwan.

Department of Electrical Engineering, Yuan Ze University, Taoyuan City 32003, Taiwan.

出版信息

Curr Oncol. 2025 Aug 19;32(8):472. doi: 10.3390/curroncol32080472.

Abstract

PURPOSE

Extensive-stage small cell lung cancer (ES-SCLC) has poor prognosis. While immune checkpoint inhibitors (ICIs) with chemotherapy show survival benefits in trials, real-world data from Asia are scarce. This study evaluates real-world efficacy and safety of chemotherapy with or without ICIs in Taiwanese patients with ES-SCLC and identifies survival predictors.

MATERIALS AND METHODS

A retrospective cohort study analyzed 114 patients with ES-SCLC treated between 2017 and 2023 at four Taiwanese medical centers. Patients received first-line chemotherapy alone ( = 68) or with ICIs (atezolizumab, durvalumab, pembrolizumab; = 46). Primary endpoints were overall survival (OS) and progression-free survival (PFS), assessed via Kaplan-Meier methods and Cox regression.

RESULTS

Baseline characteristics were comparable, except poorer ECOG performance (≥2) in the chemotherapy group (27% vs. 9%; = 0.021). IO-chemotherapy significantly improved OS (16.1 vs. 9.4 months; HR = 0.32, 95% CI: 0.20-0.52; < 0.001) and PFS (7.8 vs. 5.5 months; HR = 0.40, 95% CI: 0.26-0.63; < 0.001). Multivariate analysis confirmed IO-chemotherapy as an independent positive predictor (OS adjusted HR = 0.25, 95% CI: 0.14-0.44; PFS adjusted HR = 0.37, 95% CI: 0.22-0.61; both < 0.001). Skin rash was more common with IO-chemotherapy (24% vs. 3%; < 0.001). Immune-related adverse events (AEs) correlated with improved survival (median OS: 21.4 months with 1-2 AEs, 16.6 months with 3-4 AEs, 12.5 months without AEs).

CONCLUSION

Immunochemotherapy significantly improves survival in Taiwanese patients with ES-SCLC, with manageable toxicity, supporting ICIs' incorporation into standard treatment.

摘要

目的

广泛期小细胞肺癌(ES-SCLC)预后较差。虽然免疫检查点抑制剂(ICI)联合化疗在试验中显示出生存获益,但来自亚洲的真实世界数据却很匮乏。本研究评估了台湾ES-SCLC患者接受含或不含ICI化疗的真实世界疗效和安全性,并确定生存预测因素。

材料与方法

一项回顾性队列研究分析了2017年至2023年期间在台湾四家医疗中心接受治疗的114例ES-SCLC患者。患者单独接受一线化疗(n = 68)或联合ICI(阿特珠单抗、度伐利尤单抗、帕博利珠单抗;n = 46)。主要终点为总生存期(OS)和无进展生存期(PFS),通过Kaplan-Meier方法和Cox回归进行评估。

结果

除化疗组中较差的东部肿瘤协作组(ECOG)体能状态(≥2)比例更高外(27% 对9%;P = 0.021),基线特征具有可比性。免疫肿瘤学化疗显著改善了总生存期(16.1个月对9.4个月;风险比[HR] = 0.32,95%置信区间[CI]:0.20 - 0.52;P < 0.001)和无进展生存期(7.8个月对5.5个月;HR = 0.40,95% CI:0.26 - 0.63;P < 0.001)。多因素分析证实免疫肿瘤学化疗是独立的阳性预测因素(总生存期调整后HR = 0.25,95% CI:0.14 - 0.44;无进展生存期调整后HR = 0.37,95% CI:0.22 - 0.61;均P < 0.001)。皮疹在免疫肿瘤学化疗组中更常见(24% 对3%;P < 0.001)。免疫相关不良事件(AE)与生存改善相关(1 - 2次不良事件的患者中位总生存期为21.4个月,3 - 4次不良事件的患者为16.6个月,无不良事件的患者为12.5个月)。

结论

免疫化疗显著改善了台湾ES-SCLC患者的生存,毒性可控,支持将ICI纳入标准治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccba/12384557/e1bf872ad176/curroncol-32-00472-g001.jpg

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