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A phase I study evaluating combined nimotuzumab and neoadjuvant chemoradiotherapy followed by surgery in locally advanced esophageal cancer

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Abstract

Objective

The aim of this study was to evaluate the safety and efficacy of combined nimotuzumab and neoadjuvant chemoradiotherapy followed by surgery in locally advanced esophageal cancer.

Methods

Patients with clinically resectable, locally advanced esophageal cancer treated with neoadjuvant chemoradiotherapy plus nimotuzumab were eligible for study participation. Radiotherapy was administered in 1.8 Gy once daily for 5 days per week up to a total dose of 41.4 Gy. Weekly nimotuzumab (200 mg/week) was administered following paclitaxel and carboplatin on the same day for 5 weeks. The primary end-point was the pathological complete response (pCR) rate and the secondary end-point was the safety, progression-free survival (PFS) and overall survival (OS).

Results

A total of 64 patients with a median age of 58 years were enrolled in this study. pCR was observed in 51.6% patients. Grade 3 acute toxicities were observed in 6 patients (9.4%), shown as bone marrow suppression. 7 patients experienced grade 1 transient skin rash during nimotuzumab treatment. The median PFS time and OS time were 64.6 and 68.2 months.

Conclusions

Combined nimotuzumab and neoadjuvant chemoradiotherapy for clinically resectable, locally advanced esophageal cancer showed a significant anticancer effect with tolerable toxicities.

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Authors and Affiliations

  1. Department of Thoracic Surgery, Yinzhou People’s Hospital, 251 Baizhang East Road, Ningbo, 315040, Zhejiang, People’s Republic of China

    Saichun Qi, Ya Mao & Mingjun Jiang

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  1. Saichun Qi
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  2. Ya Mao
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Correspondence to Ya Mao.

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Qi, S., Mao, Y. & Jiang, M. A phase I study evaluating combined nimotuzumab and neoadjuvant chemoradiotherapy followed by surgery in locally advanced esophageal cancer. Cancer Chemother Pharmacol 84, 1115–1123 (2019). https://doi.org/10.1007/s00280-019-03944-w

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