食管鳞状细胞癌TP与FP方案同步放化疗疗效分析

Efficacy analysis of concurrent chemoradiotherapy with TP and FP regimens for esophageal squamous cell carcinoma

目的 比较紫杉醇与氟尿嘧啶联合顺铂在食管鳞状细胞癌(ESCC)同期放化疗中的疗效。方法 回顾分析2005-01-01-2015-12-31河北医科大学第四医院接受同期放化疗的348例ESCC患者临床资料,其中氟尿嘧啶+顺铂方案(FP组)295例,紫杉醇+顺铂方案(TP组)53例,采用Kaplan-Merier法分析生存率,Log-rank法进行显著性检验,比较2组患者的局部控制(LC)、长期生存情况,组间不良反应差异采用χ^(2)检验。结果 随访截至2021-03-31,中位随访时间109个月,TP组1、3、5、7和9年LC率分别为76.3%、70.0%、66.6%、61.1%和61.1%,FP组分别为83.2%、62.3%、58.6%、54.8%和50.8%,χ^(2)=0.320,P=0.572。TP组1、3、5、7和9年总生存(OS)率分别为77.4%、52.8%、43.0%、35.0%和28.0%,FP组分别为79.0%、44.7%、36.6%、29.4%和25.0%,χ^(2)=0.432,P=0.511。TP组和FP组中位OS分别为41和28个月。不良反应方面,TP组急性放射性食管炎以2级为主,无≥3级发生,而FP组有19例发生≥3级重度急性放射性食管炎,χ^(2)=15.880,P=0.004。TP组(1.9%)3级上消化道不良反应发生率低于FP组(6.8%)。TP组≥3级白细胞减少发生率较高(28.3%vs 6.4%,P<0.001),2组腹泻便秘、急性放射性肺炎、血红蛋白减低、血小板减低发生率及严重程度相当。Cox多因素分析显示,同步放化疗模式下,肿瘤部位、临床N分期及巩固化疗为影响患者预后的独立因素,肿瘤位于胸部中段和下段(HR=1.315,95%CI:1.016~1.701,P=0.037)、临床N期为危险因素(HR=1.520,95%CI:1.166~1.981,P=0.002),接受巩固化疗为生存获益因素,HR=0.716,95%CI:0.557~0.919,P=0.009。结论 放疗同时联合TP化疗作为不可切除ESCC的一线治疗方案,疗效与FP相当,且不易引起重度急性放射性食管炎及上消化道不良反应。

Objective To evaluate the efficacy and toxicity of concurrent chemoradiotherapy with paclitaxel/cisplatinum versus 5-fluorouracil/cisplatinum in patients with esophageal squamous cell carcinoma.Methods The medical records of 348 patients with esophageal squamous cell carcinoma who received concurrent chemoradiotherapy in the Fourth Hospital of Hebei Medical University from January 1,2005 to December 31,2015 were retrospectively analyzed.Of the patients enrolled, 295 received 5-fluorouracil/cisplatinum regimen(FP group)and 53 received paclitaxel/cisplatinum regimen(TP group).Survival was analyzed by Kaplan-Merier and significance tested by Log-rank method to compare local control and long-term survival in two groups, and differences in adverse effects between groups were tested by Chi-square test.Results The follow-up period ended on 31 March 2021,with a median follow-up time of 109 months.The 1-year, 3-year, 5-year and 9-year local control rates were 76.3%,70.0%,66.6%,61.1% and 61.1% for patients in TP group, respectively, and 83.2%,62.3%,58.6%,54.8% and 50.8%for patients in FP group,respectively,χ^(2)=0.320,P=0.572.The 1-year,3-year,5-year and 9-year overall survival rates were 77.4%,52.8%,43.0%,35.0% and 28.0%for patients in the TP group,respectively,and 79.0%,44.7%,36.6%,29.4% and 25%for patients in the FP group,respectively,χ^(2)=0.432,P=0.511.The median survival time in the TP group was 41months,longer than 28months in the FP group.Acute radioesophagitis in TP group was mainly grade 2,with no grade 3or above esophagitis,whereas 19patients in the FP group developed grade 3acute radioesophagitis(χ^(2)=15.880,P=0.004).The incidence of grade 3upper gastrointestinal adverse reactions was lower in the TP group than that in the FP group(1.9%vs 6.8%).The incidence of leukopenia at grade 3and above was higher in the TP group,(28.3% vs6.4%,P<0.001).Similar rates of acute radiation pneumonitis,lower gastrointestinal toxicities,hemoglobin reduction and thrombocytopenia were observed between patients in TP group versus FP group.Multivariate analysis of Cox regression model showed that tumor site,clinical N stage and consolidate chemotherapy were independent prognostic factors.The tumor located in the middle/lower thoracic(HR=1.315,95%CI=1.016-1.701,P=0.037)and the clinical stage of N3(HR=1.520,95%CI=1.166-1.981,P=0.002)were the risk factors for prognosis,while receiving consolidation chemotherapy is a survival benefit factor,HR=0.716,95%CI=0.557-0.919,P=0.009.Conclusion Patients with unresectable esophageal squamous cell carcinoma have comparable survival benefit between TP and FP regimens during concurrent chemoradiation,and present with less adverse severe acute radioesophagitis and upper gastrointestinal adverse reactions.