期刊
CANCER BIOLOGY & THERAPY
卷 13, 期 8, 页码 600-605出版社
LANDES BIOSCIENCE
DOI: 10.4161/cbt.19849
关键词
chemoradiotherapy; esophageal cancer; nimotuzumab; humanized monoclonal
类别
Overexpression of epidermal growth factor receptor in esophageal cancer is associated with poor prognosis. The present study was conducted to evaluate safety and preliminary efficacy of nimotuzumab, a humanized anti-EGFR antibody in combination with radiation and chemotherapy in advanced esophageal tumors. A Phase II clinical trial was conducted, where patients received cisplatin, 5-fluorouracil and radiotherapy, either alone or combined with six weekly infusions of nimotuzumab at the dose of 200 mg. Safety was the primary endpoint. The antitumoral objective response rate was the secondary endpoint. Epidermal growth factor receptor expression, KRAS mutation status and anti-idiotypic response were also evaluated. Sixty-three patients were included in the study. Thirty patients were entered into the control group and 33 patients received the treatment with nimotuzumab. The antibody was very well tolerated. Objective response rate was 47.8% (nimotuzumab group) and 15.4% (control group). Disease control rate was 60.9% (nimotuzumab group) and 26.9% (control group). Response and disease control rate were higher in patients with EGFR overexpressing tumors. Nimotuzumab plus chemoradiotherapy was safe and provided statistically significant objective response. A Phase III in patients with similar characteristics will be launched.
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