乔明旭, 胡伟. 派安普利联合化疗治疗晚期非鳞非小细胞肺癌的疗效分析. 2025. biomedRxiv.202508.00045
派安普利联合化疗治疗晚期非鳞非小细胞肺癌的疗效分析
通讯作者: 胡伟, 13938592975@139.cpm
DOI:10.12201/bmr.202508.00045
Clinical Efficacy of Penpulimab Combined Chemotherapy in Non-Squamous NSCLC
Corresponding author: HU Wei,, 13938592975@139.cpm
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摘要:目的 探讨国产新型PD-1抑制剂派安普利单抗联合化疗治疗晚期非鳞非小细胞肺癌(Non-Small Cell Lung Cancer, NSCLC)治疗中的临床疗效。方法 回顾性选取2021年10月至2022年12月在本院确诊为转移性或局部晚期非鳞NSCLC的患者,分为对照组(接受标准含铂双药化疗)和观察组(接受派安普利单抗联合化疗)。比较两组患者的客观缓解率(Objective response rate, ORR)、无进展生存期(Progression-free survival, PFS)、肺癌相关肿瘤标志物(CYFRA21-1, CEA)水平及免疫功能相关指标(CD3+, CD4+, CD8+细胞阳性率及CD4+/CD8+比值)的变化并评估不良反应的发生情况。结果 经过六个周期治疗,观察组的ORR明显高于对照组(55.6%和34.4%,P=0.029),PFS亦显著延长(17.0个月和11.0个月,P<0.05);治疗后,观察组的CYFRA21-1、CEA表达水平显著低于对照组(P<0.05);免疫功能分析显示,观察组CD3+, CD4+细胞阳性率、CD4+/CD8+比值较对照组显著升高,而CD8+细胞阳性率显著下降(P<0.05)。安全性分析显示,两组患者在恶心呕吐、贫血、肝肾毒性、皮疹方面差异无统计学意义(P>0.05),但观察组中性粒细胞减少症发生率高于对照组(P<0.05)。结论 在转移性或局部晚期非鳞NSCLC治疗过程中,采用含铂双药联合化疗基础上应用PD-1抑制剂派安普利单抗能够显著提高疗效、优化肿瘤标志物水平、改善机体免疫功能、并延长无进展生存期。
Abstract: Objective To evaluate the clinical efficacy of Penpulimab, a novel domestic PD-1 inhibitor, combined with chemotherapy in the treatment of advanced non-squamous non-small cell lung cancer (Non-Small Cell Lung Cancer, NSCLC). Methods Patients diagnosed with metastatic or locally advanced non-squamous NSCLC in our hospital from October 2021 to December 2022 were retrospectively selected and divided into a control group (receiving standard platinum-containing dual drug chemotherapy) and an observation group (receiving piamprimab combined chemotherapy). The objective response rate (Objective response rate,ORR), progression-free survival (PFS), tumor markers (CYFRA21-1 and CEA), immune function indicators (CD3+, CD4+, CD8+ cell positivity, and CD4+/CD8+ ratio), and adverse events were compared between the two groups. Results After six cycles of treatment, the ORR in the observation group was significantly higher than that in the control group (55.6% vs. 34.4%, P=0.029), and the PFS was also significantly longer (17.0 months vs. 11.0 months, P<0.05). Post-treatment, CYFRA21-1 and CEA levels were significantly lower in the observation group compared to the control group (P<0.05). Additionally, immune function analysis showed that CD3+ and CD4+ cell positivity and the CD4+/CD8+ ratio significantly increased, while CD8+ cell positivity decreased, with a greater improvement observed in the observation group (P<0.05). Both groups experienced varying degrees of adverse effects; however, symptoms were effectively managed. No statistically significant differences were found between the two groups regarding nausea, vomiting, anemia, hepatotoxicity, nephrotoxicity, or rash (P>0.05), but the incidence of neutropenia was higher in the observation group (P<0.05). Conclusion The combination of Penpulimab with platinum-based chemotherapy significantly improves treatment efficacy, reduces tumor marker levels, enhances immune function, and prolongs progression-free survival in patients with advanced non-squamous NSCLC.
Key words: Non-squamous NSCLC; Penpulimab; Chemotherapy; Immunotherapy; Survival提交时间:2025-08-22
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序号 提交日期 编号 操作 1 2025-04-14 bmr.202508.00045V1
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