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

Abstract

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 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. 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.

Effectiveness and Safety of Targeted Agents Combined With Chemoradiotherapy for the Treatment of Esophageal Cancer: A Network Meta-Analysis

“…Furthermore, when combined with chemotherapy, nivolumab can significantly improve OS and PFS (36), but hyperprogressive disease in elderly people and immune-related pneumonia still need to be considered (37). EGFR is widely overexpressed in EC patients and is associated with poor prognosis (38,39). Erlotinib increases the radiosensitivity of tumor cells, showed potential advantages in the OS results and borderline statistically significant in PFS results in our study.…”

“…EGFR is widely overexpressed in EC patients and is associated with poor prognosis ( 38 , 39 ). Erlotinib increases the radiosensitivity of tumor cells, showed potential advantages in the OS results and borderline statistically significant in PFS results in our study.…”

Development of a prognostic nomogram and risk stratification system for upper thoracic esophageal squamous cell carcinoma

“…For the high-risk group with upper ESCC, the present radical treatment seems inadequate, and more aggressive treatment strategies are urgently required to improve prognosis. Recently, the administration of an additional targeting agent during radiotherapy for older patients or neoadjuvant chemoradiotherapy for locally advanced EC, such as nimotuzumab, were initially reported as a feasible anticancer strategy [29]. Therefore, further studies are warranted to con rm such targeting and neoadjuvant therapeutic effects on upper thoracic ESCC.…”

Development of a Prognostic Nomogram and Risk Stratification System for Upper Thoracic Esophageal Squamous Cell Carcinoma

“…For the high-risk group with upper ESCC, the present radical treatment seems inadequate, and more aggressive treatment strategies are urgently required to improve prognosis. Recently, the administration of an additional targeting agent during radiotherapy for older patients or neoadjuvant chemoradiotherapy for locally advanced EC, such as nimotuzumab, were initially reported as a feasible anticancer strategy [27,28]. Therefore, further studies are warranted to con rm such targeting and neoadjuvant therapeutic effects on upper thoracic ESCC.…”