首页|帕博利珠单抗联合化疗治疗晚期不可切除食管鳞状细胞癌的效果

帕博利珠单抗联合化疗治疗晚期不可切除食管鳞状细胞癌的效果

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目的 探究帕博利珠单抗联合化疗对晚期不可切除食管鳞状细胞癌患者的疗效.方法 遴选2019年12月至2022年9月郑州大学第一附属医院收治的晚期食管鳞状细胞癌患者纳入研究,依据治疗方法的不同进行分组,将采用化疗方案(紫杉类+顺铂)治疗的患者纳入化疗组,将采用帕博利珠单抗联合化疗方案的患者纳入免疫联合组,经倾向性评分匹配排除年龄、性别混杂因素,经1:1匹配法两组各纳入34例.比较两组近期实体瘤疗效和生存情况,治疗前后肿瘤标志物[鳞状细胞癌抗原(SCCA)、糖抗原242(CA242)和细胞角蛋白19片段(CYFRA21-1)]、血清可溶性程序性死亡蛋白1/可溶性程序性死亡蛋白配体1(sPD-1/sPD-L1)及人转化生长因子-β1(TGF-β1)水平变化,记录两组药品不良反应.结果 免疫联合组疾病客观缓解率(67.65%)高于化疗组(41.18%)(P<0.05),两组疾病控制率(88.24%vs 85.29%)比较差异无统计学意义(P>0.05);免疫联合组总生存期(OS)(11.47±0.33)个月,无病生存期(DFS)(11.03±0.47)个月,1年生存率及无病生存率91.18%、76.47%,化疗组对应为(11.01±0.48)个月、(8.85±1.13)个月、85.29%、61.76%,两组OS比较差异无统计学意义(log rank χ2=0.598,P>0.05),DFS比较差异有统计学意义(log rank χ2=4.216,P<0.05);治疗4个周期后,免疫联合组血清SCCA、CA242和CYFRA21-1水平[分别为(3.14±0.61)ng·mL-1,(50.12±6.88)U·mL-1,(3.57±0.71)μg·L-1]低于化疗组[分别为(3.81±0.74)ng·mL-1,(57.53±7.14)U·mL-1,(4.43±0.83)μg·L-1](t=4.074、4.358、4.591,均P<0.05);治疗4个周期后,免疫联合组血清sPD-1/sPD-L1、TGF-β1水平[分别为(0.69±0.07)ng·mL-1,(33.47±6.47)ng·mL-1]低于化疗组[分别为(0.75±0.05)ng·mL-1,(40.65±7.12)ng·mL-1](t=4.067、4.067,均P<0.05);免疫联合组药品不良反应(胃肠道反应、过敏性皮疹、贫血和肝肾损伤)与化疗组比较,差异无统计学意义(P>0.05).结论 帕博利珠单抗联合化疗治疗食管鳞状细胞癌可明显改善肿瘤标志物水平及血清免疫状态.
Efficacy of pembrolizumab combined with chemotherapy in treatment of advanced unresectable esophageal squamous cell carcinoma
Objective To explore the efficacy of pembrolizumab combined with chemotherapy in treatment of advanced unresectable esophageal squamous cell carcinoma(ESCC).Methods A total of 68 patients with advanced ESCC treated in the First Affiliated Hospital of Zhengzhou University from December 2019 to September 2022 were enrolled in this study.According to different treatment methods,patients treated with chemotherapy(taxane+cisplatin)were included in the chemotherapy group and those who adopted pembrolizumab combined with chemotherapy were included in the immune combination group.After propensity score matching,confounding factors such as age and gender were excluded,34 cases were included in each group with 1:1 matching.The short-term solid tumor efficacy and survival status and changes of tumor markers(squamous cell carcinoma antigen(SCCA),carbohydrate antigen 242(CA242),cytokeratin 19 fragment(CYFRA21-1)),serum soluble programmed death protein 1/soluble programmed death protein ligand 1(sPD-1/sPD-L1)and human transforming growth factor-β1(TGF-β1)levels before and after treatment were compared.The adverse reaction of drugs were recorded.Results The objective remission rate of disease was significantly higher in the immune combination group than in the control(67.65%vs 41.18%,P<0.05),but there was no statistical significance in disease control rate between the two groups(88.24%vs 85.29%,P>0.05).The overall survival(OS),disease-free survival(DFS),1-year survival rate and disease-free survival rate were(11.47±0.33)months,(11.03±0.47)months,91.18%and 76.47%in the immune combination group and(11.01±0.48)months,(8.85±1.13)months,85.29%and 61.76%in the chemotherapy group.There was no statistical significance in OS between the two groups(χ2=0.598,P>0.05),but there was a statistical difference in DFS between the two groups(χ2=4.216,P<0.05).After 4 cycles of treatment,the serum levels of SCCA,CA242 and CYFRA21-1 in the immunization combination group((3.14±0.61)ng·mL-1,(50.12±6.88)U·mL-1,(3.57±0.71)μg·L-1)was lower than that in the chemotherapy group((3.81±0.74)ng·mL-1,(57.53±7.14)U·mL-1,(4.43±0.83)μg·L-1)(t=4.074,4.358,4.591,all P<0.05).After 4 cycles of treatment,the serum levels of sPD-1/sPD-L1 and TGF-β1 in the immunization group((0.69±0.07)μg·L-1 and(33.47±6.47)ng·mL-1,respectively)were lower than those in the chemotherapy group((0.75±0.05)μg·L-1,(40.65±7.12)ng·mL-1)(t=4.067,4.067,both P<0.05).The adverse reaction of drugs(gastrointestinal reaction,allergic skin rash,anemia and liver and kidney injury)showed no statistical differences between the two groups(P>0.05).Conclusion Pembrolizumab combined with chemotherapy in the treatment of ESCC can significantly improve tumor marker levels and serum immune status.

Esophageal squamous cell carcinomaPembrolizumabChemotherapySurvival timeTumor markerSerum immune status

赵佳、李向楠、张国庆、慕腾

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郑州大学第一附属医院胸外科,郑州 450000

食管鳞状细胞癌 帕博利珠单抗 化疗 生存期 肿瘤标志物 血清免疫状态

国家自然科学基金资助项目

32070623

2024

中国药物应用与监测
中国人民解放军总医院

中国药物应用与监测

CSTPCD
影响因子:1.983
ISSN:1672-8157
年,卷(期):2024.21(3)
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