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Nimotuzumab (N) is a humanized anti‐epidermal growth factor receptor monoclonal antibody. This prospective, single‐armed, open label phase  II  study was conducted to evaluate the efficacy and safety of the combination of paclitaxel (T)/cisplatin (P) with nimotuzumab (N) as first‐line treatment in advanced esophageal squamous cell carcinoma ( ESCC ). Patients with pathologic confirmed unresectable locally advanced or metastatic  ESCC  were treated with the  TPN  regimen: nimotuzumab 200 mg weekly, paclitaxel 175 mg/m 2  on day 1 and cisplatin 30 mg/m 2  on days 1 and 2; repeat cycle every 3 weeks for six cycles. Radiotherapy was allowed to be admitted after four cycles of  TPN  treatment. The primary endpoint was the objective response rate ( ORR ). The secondary endpoint was the overall survival ( OS ), duration of disease control ( DDC ) and toxicities. From March 2011 to April 2013, a total of 59 patients were enrolled and 56 were eligible for the final analysis. Overall  RR  was 51.8% and disease control rate ( DCR ) ( CR  +  PR  +  SD ) was 92.9%. Local treatment (radiotherapy or surgery) followed by chemotherapy improved the duration of disease control for patients with metastatic disease and local‐regional advanced disease to 8.2 months and more than 23 months, respectively. The  OS  for patients with metastatic disease was 14.0 months (95%  CI : 6.8–21.2 months). The most common G3/4 toxicities were neutropenia (46.4%), nausea (48.3%), alopecia (78.6%), anorexia (42.8%), vomiting (55.4%), arthralgia (62.5%) and anorexia (5%). Adding nimotuzumab to the standard  TP  regiment was safe, and well tolerated. The  TPN  regimen is an effective combination as the first‐line chemotherapy for the patients with advanced  ESCC , and appears more active than current standard regimens.

cancer science

Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase  II  trial