含铂新辅助免疫治疗用于三阴性乳腺癌的临床探究OACSTPCD
Clinical efficacy and safety of platinum-containing neoadjuvant immunotherapy for triple-negative breast cancer
目的 探究含铂新辅助免疫治疗三阴性乳腺癌的临床疗效及安全性.方法 收集程序性死亡受体-11(PD-1)阳性的三阴性乳腺癌患者64例,将其随机分为对照组与观察组各32例.对照组在术前给予化学治疗[白蛋白紫杉醇+顺铂(TP)方案],观察组在对照组TP方案基础上联合使用PD-1抑制剂卡瑞丽珠单抗进行术前新辅助免疫治疗.新辅助免疫治疗完成后4周,按照手术适应证选择改良根治术或保乳术,并根据术中前哨淋巴结活组织检查的结果决定是否进行腋窝淋巴结清扫.比较2组患者的客观缓解率、疾病控制率、病理学完全缓解率、保乳率、腋窝淋巴结豁免率、T淋巴细胞亚群水平、乏氧诱导因子-1α水平、血管内皮生长因子水平以及不良反应发生率.结果 经过6个周期的新辅助免疫化学治疗后,观察组的客观缓解率、病理学完全缓解率、CD4+T淋巴细胞水平均高于对照组(P均＜0.05);观察组的乏氧诱导因子-1α和血管内皮生长因子水平均低于对照组(P均＜0.05).虽然观察组的疾病控制率、保乳率和腋窝淋巴结豁免率也相对较高,但与对照组比较差异无统计学意义(P均＞0.05).2组不良反应发生率比较差异无统计学意义(P＞0.05).结论 含铂新辅助免疫治疗用于三阴性乳腺癌的临床疗效较为可观,能降低患者肿瘤负荷,改善患者预后,且较安全.
Objective To evaluate the clinical efficacy and safety of platinum-containing neoadjuvant immunotherapy for triple-negative breast cancer.Methods Sixty-four patients with PD-L1 positive triple-negative breast cancer were enrolled and randomly divided into the control(n=32)and observation groups(n=32).In the control group,preoperative chemotherapy regimen of albumin-bound paclitaxel plus cisplatin(TP)was given,while the observation group received platinum-containing neoadjuvant immunotherapy--combined with programmed death receptor-1(PD-1)inhibitor carrilizumab on the basis of TP chemotherapy regimen of control group.At 4 weeks post-neoadjuvant chemotherapy,whether modified radical surgery or breast-conserving surgery was chosen based on surgical indications,and whether axillary lymph node dissection was performed according to intraoperative sentinel lymph node biopsy results.The objective response rate,disease control rate,pathological complete response rate,breast conservation rate,axillary lymph node exemption rate,T lymphocyte subset levels,hypoxia-inducible factor-1alevels,vascular endothelial growth factor levels,and the incidence of adverse reactions were compared between two groups.Results After 6 cycles of neoadjuvant chemotherapy,the objective remission rate,pathological complete remission rate,and elevated level of CD4+T lymphocytes in the observation group were higher than those in the control group(all P＜0.05).The levels of hypoxia-inducible factor-1a and vascular endothelial growth factor in the observation group were lower than those in the control group(all P＜0.05).Although the disease control rate,breast conservation rate and exemption rate of axillary lymph node dissection were relatively high in the observation group,the difference was not significant when compared with that in the control group(P＞0.05).There was no significant difference in the incidence of adverse reactions between two groups(P＞0.05).Conclusion Platinum-containing neoadjuvant immunotherapy is efficacious and safe for triple-negative breast cancer,which reduces the tumor load and improves clinical prognosis of the patients.
殷雨来;张银旭;任悦;张辉;张晓宇
061000 沧州,河北医科大学附属沧州市中心医院甲状腺乳腺外三科
三阴性乳腺癌程序性死亡受体-1抑制剂新辅助免疫治疗保乳术腋窝淋巴结清扫病理学完全缓解
Triple-negative breast cancerProgrammed death receptor-1 inhibitorNeoadjuvant immunotherapyBreast-conserving surgeryAxillary lymph node dissectionPathologic complete response
《新医学》 2024 (001)
12-18 / 7
河北省医学科学研究课题(20220400)
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