J Cancer 2019; 10(6):1409-1416. doi:10.7150/jca.28659

Research Paper

Nimotuzumab Plus Paclitaxel and Cisplatin as a 1st-Line Treatment for Esophageal Cancer: Long Term Follow-up of a Phase II Study

Xiaodong Zhang1*✉, Jun Jia1*, Ming Lu2*, Xicheng Wang2, Jifang Gong2, Jie Li2, Jian Li2, Yan Li2, Xiaotian Zhang2, Zhihao Lu2, Jun Zhou2, Jing Yu1, Zhiwei Sun1, Ying Yang1, Chuanling Liu1, Yanjie Xiao1, Lin Shen2✉

1. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The VIP-II Gastrointestinal Cancer Division of Medical Department, Peking University Cancer Hospital & Institute, Beijing 100142, China.
2. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of GI Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
* These authors contributed equally.

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Citation:
Zhang X, Jia J, Lu M, Wang X, Gong J, Li J, Li J, Li Y, Zhang X, Lu Z, Zhou J, Yu J, Sun Z, Yang Y, Liu C, Xiao Y, Shen L. Nimotuzumab Plus Paclitaxel and Cisplatin as a 1st-Line Treatment for Esophageal Cancer: Long Term Follow-up of a Phase II Study. J Cancer 2019; 10(6):1409-1416. doi:10.7150/jca.28659. Available from http://www.jcancer.org/v10p1409.htm

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Abstract

The effect of anti-epidermal growth factor receptor targeted treatment in esophageal squamous cell carcinoma (ESCC) is still unclear. We conducted a prospective phase II study of paclitaxel, cisplatin, and nimotuzumab (TPN) as a first-line treatment for unresectable or metastatic ESCC and the objective response rate was 51.8%. Here, we report the long-term follow-up results of the initial trial. Fifty-nine patients were enrolled from Mar 2011 to Apr 2013 and were treated with the TPN regimen. Palliative sequential radiotherapy was given if all tumor lesions were confined to 1-2 radiation fields. Fifty-six patients were eligible for evaluation. After a median follow-up of 32.2months, the median progression-free survival (PFS) and the overall survival (OS) time were 18.1±4.2 months (95% CI: 9.8-26.4) and 26.2±10.0 months (95% CI: 6.6-45.8), respectively, in 29 patients with unresectable local-regional disease, while they were 6.6±0.4 months (95% CI: 5.8-7.5) and 11.5±3.7 months (95% CI: 4.2-18.8), respectively, in 27 patients with metastatic disease. Patients who were male, those with multiple station lymph node metastases, those with visceral metastasis, those who did not response to TPN treatment, and those who did not receive radiotherapy, had a worse OS. In 6 patients with multiple station lymph node metastasis and in 3 patients with recurrent disease and oligo-metastasis (local lymph nodes), TPN with sequential radiation resulted in a mean OS of 17.67±9.50 months and a mean OS of over 40 months, respectively. In conclusion, TPN is effective as a first-line treatment for patients with unresectable and metastatic ESCC. In addition, TPN treatment with sequential radiation might improve survival in patients with limited or oligo lymph node metastases.

Keywords: cisplatin, epidermal growth factor receptor, esophageal squamous cell carcinoma, nimotuzumab, paclitaxel