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BAI/BACE联合铂类双药化疗及PD-1抑制剂治疗IV期驱动基因阴性非小细胞肺癌的临床疗效和安全性

Clinical efficacy and safety of BAI/BACE combined with platinum⁃based dual⁃drug chemo⁃therapy and PD⁃1 inhibitor in stageⅣdriver gene⁃negative non⁃small cell lung cancer
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摘要 目的探讨支气管动脉灌注术(bronchial arterial infusion,BAI)和支气管动脉化疗栓塞术(bronchial arterial chemoembolization,BACE)联合铂类双药化疗及PD-1抑制剂作为IV期驱动基因阴性非小细胞肺癌(non-small cell lung cancer,NSCLC)一线治疗方案的临床疗效。方法分析成都市第六人民医院2020年4月至2024年10月收治的91例IV期驱动基因阴性NSCLC患者的临床资料。根据治疗方式将患者分为两组,BAI组(n=47)接受BAI/BACE联合铂类双药化疗及PD-1抑制剂治疗,非BAI组(n=44)仅接受铂类双药化疗及PD-1抑制剂治疗。比较两组的近期疗效、无进展生存期(progression-free survival,PFS)、总生存期(overall survival,OS)、治疗结束后90 d内≥1级不良事件发生率。结果BAI组的客观缓解率高于非BAI组(68.1%vs 47.7%,P=0.049),PFS(P=0.021)与OS(P=0.012)均较非BAI组延长,中位PFS为12个月vs 8个月,中位OS为18个月vs 11个月。Two-stage分析结果显示,在早期阶段(≤12个月),BAI组的PFS和OS均显著优于非BAI组(均P=0.003)。对BAI组进行亚组分析发现,中央型患者的PFS和OS有优于周围型患者的趋势(中位PFS:15个月vs 11个月;中位OS:21个月vs 16个月),且晚期阶段(>12个月)中央型患者的PFS(P=0.022)和OS(P=0.037)显著优于周围型患者(中位PFS:7个月vs 2个月;中位OS:14个月vs 6个月)。多因素Cox比例风险回归分析结果显示,BAI/BACE联合铂类双药化疗及PD-1抑制剂治疗是PFS和OS的独立保护因素(均P<0.05)。两组不良反应均以I~II级为主,发生率无显著差异。结论BAI/BACE联合铂类双药化疗及PD-1抑制剂在IV期驱动基因阴性NSCLC患者的一线治疗中展现出良好的疗效和可控的安全性,为患者带来了明显的生存获益。 Objective To investigate the clinical efficacy of bronchial arterial infusion(BAI)/bronchial arterial chemoembolization(BACE)combined with platinum⁃based dual⁃drug chemotherapy and PD⁃1 inhibitor as first⁃line treatment for stageⅣdriver gene⁃negative non⁃small cell lung cancer(NSCLC).Methods Clinical data of 91 patients with stageⅣdriver gene⁃negative NSCLC treated at the Chengdu Sixth People′s Hospital between April 2020 and October 2024 were analyzed.Patients were categorized into two cohorts based on their treatment regimen:the BAI group(n=47)received BAI/BACE combined with platinum⁃based dual⁃drug chemotherapy and PD⁃1 inhibitor,and the non⁃BAI group(n=44)received platinum⁃based dual⁃drug chemotherapy and PD⁃1 inhibitor alone.Short⁃term efficacy,progression⁃free survival(PFS),overall survival(OS),and the incidence of adverse events(≥grade 1)within 90 days post⁃treatment were compared between the two groups.Results The objective response rate was significantly higher in the BAI group than in the non⁃BAI group(68.1%vs 47.7%,P=0.049).Additionally,the BAI group showed significantly better PFS(P=0.021)and OS(P=0.012),with median PFS of 12 months vs 8 months and median OS of 18 months vs 11 months.Two⁃stage analysis revealed that during the early stage(≤12 months),the BAI group demonstrated significantly superior PFS and OS compared to the non⁃BAI group(all P=0.003).Subgroup analysis of the BAI group showed a trend toward better PFS and OS in patients with central⁃type tumors com⁃pared to those with peripheral⁃type tumors(median PFS:15 months vs 11 months;median OS:21 months vs 16 months).Furthermore,in the advanced stage(>12 months),patients with central⁃type tumors demonstrated significantly better PFS(P=0.022)and OS(P=0.037)than those with peripheral⁃type tumors(median PFS:7 months vs 2 months;median OS:14 months vs 6 months).Multivariate Cox proportional hazards regression analysis confirmed that treatment with BAI/BACE combined with platinum⁃based dual⁃drug chemo⁃therapy and PD⁃1 inhibitor was an independent protective factor for both PFS and OS(all P<0.05).Adverse reactions in both groups were predominantly gradeⅠ-Ⅱ,with no significant difference in incidence rates.Conclusions BAI/BACE combined with platinum⁃based dual⁃drug chemotherapy and PD⁃1 inhibitor demonstrated favorable efficacy and manageable safety in first⁃line treatment for stageⅣdriver gene⁃negative NSCLC patients,delivering significant survival benefits.
作者 权小英 陈小艳 雷蕾 贾晓利 吴春芝 叶斌 黄琪越 罗敏 王宁 余家洋 冯礼夫 QUAN Xiaoying;CHEN Xiaoyan;LEI Lei;JIA Xiaoli;WU;Chunzhi;YE Bin;HUANG Qiyue;LUO Min;WANG Ning;YU Jiayang;FENG Lifu(Department of Oncology,Chengdu Sixth People′s Hospital,Chengdu 610051,China)
出处 《中国癌症防治杂志》 2025年第6期697-704,共8页 CHINESE JOURNAL OF ONCOLOGY PREVENTION AND TREATMENT
基金 成都市医学科研课题(2022177)。
关键词 非小细胞肺癌 支气管动脉灌注术 支气管动脉化疗栓塞术 免疫治疗 化疗 Non⁃small cell lung cancer Bronchial arterial infusion Bronchial arterial chemoembolization Immunotherapy Che⁃motherapy
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