请关注微信公众平台

Effectiveness and safety of combined nimotuzumab and S-1 chemotherapy with concurrent radiotherapy for locally advanced esophageal cancer in malnourished and elderly patients: A prospective phase II study
doi: 10.21147/j.issn.1000-9604.2024.03.04
ObjectiveDefinitive chemoradiotherapy (dCRT) is the standard treatment for unresectable locally advanced esophageal cancer. However, this treatment is associated with substantial toxicity, and most malnourished or elderly patients are unable to complete this therapy. Therefore, there is a need for a more suitable radiotherapy combination regimen for this population. This study was aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients with fragile locally advanced esophageal cancer with a high Nutritional Risk Screening 2002 (NRS-2002) score.MethodsEligible patients with unresectable esophageal carcinoma who had an NRS-2002 score of 2 or higher were enrolled. They were treated with S-1 and nimotuzumab with concurrent radiotherapy, followed by surgery or definitive radiotherapy. The primary endpoint was the locoregional control (LRC) rate.ResultsA total of 55 patients who met the study criteria were enrolled. After completion of treatment, surgery was performed in 15 patients and radiotherapy was continued in 40 patients. The median follow-up period was 33.3 [95% confidence interval (95% CI), 31.4−35.1)] months. The LRC rate was 77.2% (95% CI, 66.6%−89.4%) at 1 year in the entire population. The overall survival (OS) rate and event-free survival (EFS) rate were 57.5% and 51.5% at 3 years, respectively. Surgery was associated with better LRC [hazard ratio (HR)=0.16; 95% CI, 0.04−0.70; P=0.015], OS (HR=0.19; 95% CI, 0.04−0.80; P=0.024), and EFS (HR=0.25; 95% CI, 0.08−0.75; P=0.013). Most adverse events were of grade 1 or 2, and no severe adverse events occurred.ConclusionsFor malnourished or elderly patients with locally advanced esophageal cancer, radiotherapy combined with nimotuzumab and S-1 is effective and has a good safety profile.
关键词: Esophageal carcinoma, squamous cell carcinoma, nutritional risk score, nimotuzumab, S-1, definitive chemoradiotherapy
Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients: A phase II clinical trial
doi: 10.21147/j.issn.1000-9604.2021.01.06
ObjectiveTo investigate the safety and efficacy of nimotuzumab combined with radiotherapy for elderly patients with non-resectable esophageal carcinoma (EC).MethodsEligible patients were aged 70 years or older and had treatment-naïve, histologically proven inoperable locally advanced EC. Enrolled patients received radiotherapy with a total dose of 50−60 Gy in 25−30 fractions, concurrent with weekly infusion of nimotuzumab. The primary end point was the rate of more than grade 3 toxicities.ResultsFrom June 2011 to July 2016, 46 patients with stage II−IV EC with a median age of 76.5 years were enrolled. There were 10, 28 and 8 patients with stage II, III and IV disease, respectively. The common acute toxicities included esophagitis (grade 1−2, 75.4%; grade 3, 8.7%), pneumonitis (grade 1, 4.3%; grade 2, 6.5%; grade 3, 2.2%), leukopenia (grade 1−2, 60.9%; grade 3−4, 4.4%), gastrointestinal reaction (grade 1−2, 17.3%; grade 3, 2.2%), thrombocytopenia (grade 1−2, 21.7%; grade 3, 2.2%), and radiothermitis (grade 1−2, 39.2%). The incidence of grade 3−4 adverse effects was 17.4%. No grade 5 toxicities were observed. Clinical complete response, partial response, stable disease, and progressive disease were observed in 1 (2.2%), 31 (67.4%), 12 (26.1%), and 2 (4.3%) patients, respectively. The median overall survival (OS) and progression-free survival (PFS) were 17 and 10 months, respectively. The 2-, 3-, and 5-year OS and PFS rates were 30.4%, 21.7%, 19.6%, and 26.1%, 19.6%, 19.6%, respectively.ConclusionsNimotuzumab combined with radiotherapy is a safe and effective therapy for elderly patients who are not surgical candidates. Further studies are warranted to confirm its therapeutic effects in elderly EC patients.
关键词: Nimotuzumab, esophageal neoplasm, elderly, radiotherapy, treatment outcome
主管单位: 中国科学院
主办单位: 中国电子学会

京ICP备05032737 号-2

版权所有:
通讯地址:
工作邮箱:
办公电话: 020-37627489

本系统由 北京仁和汇智信息技术有限公司 开发 技术支持: info@rhhz.net京ICP备15040398号-1   百度统计