韩 尚,纪雅玲,王 浩,等.免疫跨线联合白蛋白结合型紫杉醇对比安罗替尼联合白蛋白结合型紫杉醇二线治疗晚期肺腺癌的疗效及预后分析[J].肿瘤学杂志,2024,30(4):314-320.
免疫跨线联合白蛋白结合型紫杉醇对比安罗替尼联合白蛋白结合型紫杉醇二线治疗晚期肺腺癌的疗效及预后分析
Efficacy of Albumin-Conjugated Paclitaxel Combined with Immunotherapy Beyond Progression Versus Anlotinib for Advanced Lung Adenocarcinoma as Second-Line Treatment
投稿时间:2023-11-06  
DOI:10.11735/j.issn.1671-170X.2024.04.B008
中文关键词:  肺肿瘤  腺癌  二线治疗  免疫疗法  免疫检查点抑制剂  安罗替尼  紫杉醇
英文关键词:lung neoplasms  adenocarcinoma  second-line treatment  immunotherapy  immune checkpoint inhibitor  Anlotinib  Paclitaxel
基金项目:
作者单位
韩 尚 徐州医科大学附属医院 
纪雅玲 徐州医科大学附属医院 
王 浩 徐州医科大学附属医院 
汪海岩 徐州医科大学附属医院 
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中文摘要:
      摘 要:[目的]评估一线治疗中免疫检查点抑制剂(immune checkpoint inhibitor,ICI)联合化疗后出现进展的晚期肺腺癌患者,在二线治疗中应用免疫跨线联合化疗对比多靶点血管生成抑制剂(安罗替尼)联合化疗(白蛋白结合型紫杉醇)的临床疗效和预后。[方法] 回顾性分析徐州医科大学附属医院2020年1月至2023年5月收治的一线治疗中ICI联合化疗进展的80例驱动基因阴性的晚期肺腺癌患者资料,分为免疫跨线联合化疗组(A组,n=42)和安罗替尼联合化疗组(B组,n=38)。分析两组的疗效差异,Cox比例风险回归模型和 Kaplan-Meier曲线评估治疗方案与无进展生存期 (progression-free survival,PFS) 和总生存期 (overall survival,OS)的关系,并通过亚组分析评估不同治疗方案的获益患者。[结果] A组和B组的客观缓解率(objective response rate,ORR)分别为23.81%和39.47%(P=0.131),疾病控制率(disease control rate,DCR)分别为59.52%和84.21%(P=0.015);中位PFS分别为6.3个月和7.7个月(P=0.048),中位OS分别为11.5个月和14.5个月(P=0.049)。两组常见毒副反应为食欲减退、皮疹、腹泻、甲状腺功能异常等,经对症处理均可耐受,未发生致死性事件。[结论] 一线免疫联合化疗进展后驱动基因阴性的晚期肺腺癌患者的二线治疗中,整体人群的临床疗效中安罗替尼联合化疗优于免疫跨线联合化疗,在亚组分析中免疫跨线联合化疗组及安罗替尼联合化疗组有各自的优势人群,疗效确切且毒副反应可耐受。
英文摘要:
      Abstract: [Objective] To evaluate the clinical efficacy of albumin-conjugated paclitaxel combined with immunotherapy beyond progression versus multi-targeted angiogenesis inhibitor (Anlotinib) in second-line treatment for advanced lung adenocarcinoma patients who have progressed after (ICI) combination chemotherapy in first-line treatment. [Methods] Eighty driver gene-negative advanced lung adenocarcinoma patients with progression after immune checkpoint inhibitor (ICI) therapy with chemotherapy were admitted in the Affiliated Hospital of Xuzhou Medical University from January 2020 to May 2023. Patients were received albumin-conjugated Paclitaxel with immunotherapy beyond progression (Group A, n=42) or albumin-conjugated Paclitaxel combined with Anlotinib (Group B, n=38). The efficacy was compared between the two groups. The progression-free survival (PFS) and overall survival (OS) in two groups were assessed by Cox proportional risk regression model and Kaplan-Meier curve; and the beneficial patients of different treatment regimens were evaluated by subgroup analysis. [Results] There was no significant difference in objective response rate (ORR) between group A and group B (23.81% vs 39.47%, P=0.131), while the disease control rate (DCR) , the median PFS and OS of group A was lower than those of group B (59.52% vs 84.21%, P=0.015; 6.3 months vs 7.7 months, P=0.048; 11.5 months vs 14.5 months, P=0.049, respectively). The common toxicity in both groups were loss of appetite, rash, diarrhea, and thyroid function abnormality, etc., which was tolerated with symptomatic treatment and no lethal events occurred. [Conclusion] For advanced lung adenocarcinoma patients with driver-negative genes after progression of first-line immune-combination chemotherapy, Anlotinib combined chemotherapy as second-line treatment is generally superior to immunotherapy beyond progression combined with chemotherapy, however, the subgroup analysis shows that each regime has their own beneficial patient population.
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