Ma Ning-Yi, Cai Xu-Wei, Fu Xiao-Long, Li Yuan, Zhou Xiao-Yan, Wu Xiang-Hua, Hu Xi-Chun, Fan Min, Xiang Jia-Qing, Zhang Ya-Wei, Chen Hai-Quan, Lai Song-Tao, Jiang Guo-Liang, Zhao Kuai-Le
Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 270 Dongan Road, Shanghai, 200032, China.
Int J Clin Oncol. 2014 Apr;19(2):297-302. doi: 10.1007/s10147-013-0564-3. Epub 2013 May 21.
We investigated nimotuzumab (h-R3), a humanized monoclonal antibody against epidermal growth factor receptor, when combined with irradiation or chemoradiation for squamous cell carcinoma (SCC) of the esophagus. The aim of this study was to evaluate its safety and efficacy.
We retrospectively analyzed 66 patients with esophageal SCC treated with a combination of h-R3 and radiation or chemoradiation between December 2008 and September 2011 at Fudan University Shanghai Cancer Center. Fifty-two of the 66 patients received h-R3 combined with chemoradiation and 14 received h-R3 plus radiation. The median total irradiation dose was 61 Gy given by conventional fractionation. The h-R3 weekly dosage was 100 mg (6/66), 200 mg (54/66), or 400 mg (6/66) given concurrently during the irradiation period.
Patients tolerated the treatment well. Grade 3-4 adverse events and toxicities occurred in 50 % of the patients. h-R3-related toxicities manifested as Grade 1 skin rash in 1 case and Grade 2 infusion-related reaction in 2 cases. The median overall survival (OS) and progression-free survival (PFS) were 26.0 months and 16.7 months, respectively. OS, PFS and locoregional control (LC) at 2 years were 54, 37 and 80 %, respectively.
h-R3 in combination with irradiation or chemoradiation was safe and tolerable, and yielded encouraging OS, PFS and LC.
我们研究了尼妥珠单抗（h-R3），一种抗表皮生长因子受体的人源化单克隆抗体，与放疗或放化疗联合用于食管鳞状细胞癌（SCC）的疗效。本研究的目的是评估其安全性和有效性。
我们回顾性分析了2008年12月至2011年9月在复旦大学附属肿瘤医院接受h-R3联合放疗或放化疗的66例食管SCC患者。66例患者中，52例接受h-R3联合放化疗，14例接受h-R3联合放疗。中位总照射剂量为61 Gy，采用常规分割。h-R3的每周剂量为100 mg（6/66）、200 mg（54/66）或400 mg（6/66），在放疗期间同时给药。
患者对治疗耐受性良好。50%的患者发生3-4级不良事件和毒性反应。h-R3相关毒性反应表现为1例1级皮疹和2例2级输液相关反应。中位总生存期（OS）和无进展生存期（PFS）分别为26.0个月和16.7个月。2年时的OS、PFS和局部区域控制率（LC）分别为54%、37%和80%。
h-R3联合放疗或放化疗是安全且可耐受的，并产生了令人鼓舞的OS、PFS和LC。
