Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients: A phase Ⅱ clinical tr

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Objective: To investigate the safety and efficacy of nimotuzumab combined with radiotherapy for elderly patients with non-resectable esophageal carcinoma (EC).Methods: Eligible patients were aged 70 years or older and had treaunent-na(ǐ)ve,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.Results: From 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.Conclusions: Nimotuzumab 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.
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