Wang Chunyu, Fu Xiaolong, Cai Xuwei, Wu Xianghua, Hu Xichun, Fan Min, Xiang Jiaqing, Zhang Yawei, Chen Haiquan, Jiang Guoliang, Zhao Kuaile
Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Onco Targets Ther. 2015 Dec 30;9:117-22. doi: 10.2147/OTT.S89592. eCollection 2016.
Nimotuzumab (h-R3) is a humanized monoclonal antibody that is safe to use against epidermal growth factor receptor (EGFR). However, the available information is insufficient about the dose effect of monoclonal antibody against epidermal growth factor receptor for the treatment of esophageal squamous cell carcinoma (ESCC). We retrospectively recruited 66 patients with ESCC who were treated with h-R3 and chemoradiotherapy/radiotherapy. Patients who received more than 1,200 mg of h-R3 were classified as the high-dose group, and the remaining patients were classified as the low-dose group. The endpoint for efficacy was the overall survival. Differences in survival between the groups were analyzed using the log-rank test. The Cox proportional hazards model was used in multivariate analysis to identify independent prognostic factors. The low-dose and high-dose groups comprised 55 and eleven patients, respectively. The median follow-up time in the final analysis was 46 months. The high-dose group showed no increased incidence of toxicities compared to the low-dose group. The 1-, 2-, and 5-year overall survival rates in the low-dose and high-dose groups were 66.9%, 50.0%, 31.5% and 90.0%, 80.0%, 66.7%, respectively (P=0.04). Multivariate analyses showed that the high-dose group had better survival than the low-dose group (hazard ratio 0.28, 95% confidence interval 0.09-0.94, P=0.039). Taken together, high-dose h-R3 showed limited toxicity and improved survival in patients with ESCC.
尼妥珠单抗（h-R3）是一种人源化单克隆抗体，用于对抗表皮生长因子受体（EGFR）时使用安全。然而，关于抗表皮生长因子受体单克隆抗体治疗食管鳞状细胞癌（ESCC）的剂量效应，现有信息不足。我们回顾性招募了66例接受h-R3联合放化疗/放疗的ESCC患者。接受超过1200mg h-R3的患者被归为高剂量组，其余患者归为低剂量组。疗效终点为总生存期。使用对数秩检验分析两组之间的生存差异。多因素分析采用Cox比例风险模型来确定独立的预后因素。低剂量组和高剂量组分别包含55例和11例患者。最终分析中的中位随访时间为46个月。与低剂量组相比，高剂量组的毒性发生率没有增加。低剂量组和高剂量组的1年、2年和5年总生存率分别为66.9%、50.0%、31.5%和90.0%、80.0%、66.7%（P=0.04）。多因素分析显示，高剂量组的生存率优于低剂量组（风险比0.28，95%置信区间0.09-0.94，P=0.039）。综上所述，高剂量h-R3在ESCC患者中显示出有限的毒性并改善了生存情况。
