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. 2021 Feb 28;33(1):53-60.
doi: 10.21147/j.issn.1000-9604.2021.01.06.

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

Xu Yang  1 , Yirui Zhai  1 , Nan Bi  1 , Tao Zhang  1 , Lei Deng  1 , Wenqing Wang  1 , Xin Wang  1 , Dongfu Chen  1 , Zongmei Zhou  1 , Luhua Wang  1 , Jun Liang  1
Affiliations

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

Xu Yang et al. Chin J Cancer Res. .

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.

Keywords: Nimotuzumab; elderly; esophageal neoplasm; radiotherapy; treatment outcome.

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Figures

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OS and PFS curves of the entire study cohort. OS, overall survival; PFS, progression-free survival.
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OS curves of the high and medium EGFR expression group. OS, overall survival; EGFR, epidermal growth factor receptor.
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OS curves of group A (Charlson score =0) and group B (Charlson score ≥1). OS, overall survival.
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