Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, PR China; Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center; Guangzhou 510060, PR China.
Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center; Guangzhou 510060, PR China; Department of Information Technology, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, PR China.
Oral Oncol. 2018 May;80:1-8. doi: 10.1016/j.oraloncology.2018.03.002. Epub 2018 Mar 13.
This study aimed to evaluate the efficacy and safety in locoregionally advanced nasopharyngeal carcinoma (NPC) patients receiving concurrent chemoradiotherapy (CCRT) plus Cetuximab (CTX) or Nimotuzumab (NTZ) compared to those receiving induction chemotherapy (IC) plus CCRT.
From January 2008 to December 2013, 715 eligible patients were enrolled in the study. Using propensity scores to adjust for gender, age, Karnofsky performance status (KPS), tumor stage, node stage, and clinical stage, a well-balanced cohort was created by matching each patient who received CTX/NTZ plus CCRT (137 patients) with two patients who underwent IC plus CCRT (274 patients). The primary endpoint was overall survival (OS), and other outcome variables included disease-free survival (DFS), distant metastasis-free survival (DMFS) and loco-regional relapse-free survival (LRRFS).
The median follow-up was 57.0 months and 55.0 months for the CTX/NTZ plus CCRT group and IC plus CCRT group, respectively. No significant differences were found between the CTX/NTZ plus CCRT group and the IC plus CCRT group in 3-year OS (95.5% vs. 94.7%, P = 0.083), 3-year DFS (93.3% vs. 86.1%, P = 0.104), 3-year DMFS (96.2% vs. 92.5%, P = 0.243) and 3-year LRRFS (97.0% vs. 95.1%, P = 0.297). Patients undergoing IC plus CCRT suffered from severe hematologic toxicity and diarrhea compared with those treated with CTX/NTZ plus CCRT. The combination of CTX/NTZ with CCRT is comparable to IC plus CCRT treatment in survival outcomes for locoregionally advanced NPC patients but has a better safety profile than IC plus CCRT treatment.
本研究旨在评估局部晚期鼻咽癌（NPC）患者接受同步放化疗（CCRT）加西妥昔单抗（CTX）或尼妥珠单抗（NTZ）与接受诱导化疗（IC）加 CCRT 的疗效和安全性。
2008 年 1 月至 2013 年 12 月，共纳入 715 例符合条件的患者。采用倾向评分法调整性别、年龄、卡氏功能状态评分（KPS）、肿瘤分期、淋巴结分期和临床分期，对接受 CTX/NTZ 加 CCRT 的 137 例患者和接受 IC 加 CCRT 的 274 例患者进行匹配，建立一个匹配良好的队列。主要终点是总生存期（OS），其他结局变量包括无病生存期（DFS）、无远处转移生存期（DMFS）和无局部区域复发生存期（LRRFS）。
CTX/NTZ 加 CCRT 组和 IC 加 CCRT 组的中位随访时间分别为 57.0 和 55.0 个月。CTX/NTZ 加 CCRT 组与 IC 加 CCRT 组在 3 年 OS（95.5%比 94.7%，P=0.083）、3 年 DFS（93.3%比 86.1%，P=0.104）、3 年 DMFS（96.2%比 92.5%，P=0.243）和 3 年 LRRFS（97.0%比 95.1%，P=0.297）方面无显著差异。与接受 CTX/NTZ 加 CCRT 治疗的患者相比，接受 IC 加 CCRT 治疗的患者出现严重血液学毒性和腹泻的比例更高。CTX/NTZ 联合 CCRT 与 IC 加 CCRT 治疗局部晚期 NPC 患者的生存结局相当，但安全性优于 IC 加 CCRT 治疗。
