You Rui, Sun Rui, Hua Yi-Jun, Li Chao-Feng, Li Ji-Bin, Zou Xiong, Yang Qi, Liu You-Ping, Zhang Yi-Nuan, Yu Tao, Cao Jing-Yu, Zhang Meng-Xia, Jiang Rou, Mo Hao-Yuan, Guo Ling, Cao Ka-Jia, Lin Ai-Hua, Qian Chao-Nan, Sun Ying, Ma Jun, Chen Ming-Yuan
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, People's Republic of China.
Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, 510060, People's Republic of China.
Int J Cancer. 2017 Sep 15;141(6):1265-1276. doi: 10.1002/ijc.30819. Epub 2017 Jun 23.
To compare intensity-modulated radiotherapy (IMRT) with cisplatin (CDDP) versus cetuximab (CTX) and nimotuzumab (NTZ) for Stage II-IVb Nasopharyngeal Carcinoma (NPC). A total of 1,837 patients with stage II-IV NPC who received IMRT plus CTX or NTZ, or CDDP between January 2009 and December 2013 were included in the current analysis. Using propensity scores to adjust for potential prognostic factors, a well-balanced cohort of 715 patients was created by matching each patient who underwent IMRT plus concomitant NTZ/CTX with four patients who underwent IMRT plus concomitant CDDP (1:4). Efficacy and safety were compared between the CTX/NTZ and CDDP groups of this well-balanced cohort. Furthermore, we conducted multivariate analysis and subgroup analysis based on all the 1,837 eligible cases. There was no significant difference between CTX/NTZ group and CDDP group in terms of DFS (3-year, 86.7% vs. 86.2%, p > 0.05), LRRFS (96.2% vs. 96.3%, p > 0.05), DMFS (91.1% vs. 92.3%, p > 0.05) and OS (91.7% vs. 91.9%, p > 0.05). Subgroup analysis demonstrated a significant interaction effect between patients with IMRT plus CTX/NTZ and N3 node stage on LRRFS with the highest risk of loco-regional relapse (HR 8.85, p = 0.001). Significantly increased hematologic toxicities, gastrointestinal reactions were observed in the CDDP group (p < 0.05). Patients of 3.4-4.7% experienced severe hematologic toxicities during the treatment with concomitant CTX and NTZ. Increased rate of CTX related-skin reaction and mucositis was observed in the CTX group. CTX/NTZ used concurrently with IMRT may be comparable to those of the standard CDDP-IMRT combination for maximizing survival for patients with stage II-IVb NPC.
比较调强放疗(IMRT)联合顺铂(CDDP)与西妥昔单抗(CTX)及尼妥珠单抗(NTZ)治疗II-IVb期鼻咽癌(NPC)的效果。纳入2009年1月至2013年12月期间接受IMRT联合CTX或NTZ或CDDP治疗的1837例II-IV期NPC患者进行当前分析。采用倾向评分调整潜在预后因素,通过将每名接受IMRT联合NTZ/CTX的患者与四名接受IMRT联合CDDP的患者匹配(1:4),创建了一个平衡良好的715例患者队列。比较该平衡良好队列中CTX/NTZ组和CDDP组的疗效和安全性。此外,我们基于所有1837例符合条件的病例进行了多因素分析和亚组分析。CTX/NTZ组和CDDP组在无病生存期(3年,86.7%对86.2%,p>0.05)、局部区域复发无病生存期(96.2%对96.3%,p>0.05)、远处转移无病生存期(91.1%对92.3%,p>0.05)和总生存期(91.7%对91.9%,p>0.05)方面无显著差异。亚组分析显示,IMRT联合CTX/NTZ的患者与N3淋巴结分期之间在局部区域复发无病生存期方面存在显著交互作用,局部区域复发风险最高(风险比8.85,p=0.001)。CDDP组观察到血液学毒性和胃肠道反应显著增加(p<0.05)。3.4%-4.7%的患者在联合CTX和NTZ治疗期间出现严重血液学毒性。CTX组观察到CTX相关皮肤反应和粘膜炎发生率增加。IMRT联合使用CTX/NTZ对于II-IVb期NPC患者最大化生存期可能与标准CDDP-IMRT联合相当。