Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial
Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial
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新辅助化疗后同步放化疗与单独同步放化疗治疗局部晚期鼻咽癌：一项 III 期多中心随机对照试验。
DOI：
10.1016/j.ejca.2016.12.039
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发表时间：
2017-04-01
影响因子：
8.4
通讯作者：
Hong, Ming-Huang
中科院分区：
文献类型：
--
作者：
Cao, Su-Mei;Yang, Qi;Hong, Ming-Huang
背景：新辅助化疗(NACT)对局部晚期鼻咽癌(NPC)的作用尚不清楚。我们的目的是评价NACT联合同期放化疗(CCRT)与单纯CCRT治疗局部晚期鼻咽癌的可行性和疗效。方法：将III-IVB期(不包括T3N0-1)鼻咽癌患者随机分为NACT+CCRT(研究组)和单纯CCRT(对照组)。两组均在放疗的同时给予顺铂80 mg/m(2)，每3周一次。研究组在CCRT前接受顺铂(80 mg/m(2)dl)和氟尿嘧啶(800 mg/m(2)civ dl-5)，每3周1次，共2个周期。主要终点为无瘤生存期(DFS)和无远处转移生存期(DMFS)。次要终点为总生存期(OS)。用Kaplan-Meier方法分析事件发生时间终点的生存曲线，并用对数列检验进行比较。结果：476例患者随机分为研究组和对照组各238例。研究组3年无病生存率(82.0%，95%CI=0.77~0.87)高于对照组(74.1%，95%CI=0.68~0.80，P=0.028)。研究组3年DMFS率为86.0%，对照组为82.0%，差异有统计学意义(P=0.056)。然而，两组的OS或局部无复发生存率差异无统计学意义(OS：88.2%比88.5%，P=0.815；局部无复发生存率：94.3%比90.8%，P=0.430)。NACT期间最常见的3-4级毒性为中性粒细胞减少症(16.0%)。在联合放射治疗期间，研究组发生了显著更多的3-4级毒性反应(P<；0.001)。结论：与单纯联合放射治疗相比，NACT改善了局部区域晚期鼻咽癌的肿瘤控制，特别是在较远的部位。然而，在操作系统方面没有早期的收益。需要更长时间的随访才能确定最终的治疗效果。(C)2017爱思唯尔有限公司。保留所有权利。
Background: The role of neoadjuvant chemotherapy (NACT) for locoregionally advanced nasopharyngeal carcinoma (NPC) is unclear. We aimed to evaluate the feasibility and efficacy of NACT followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced NPC.Methods: Patients with stage III-IVB (excluding T3N0-1) NPC were randomly assigned to receive NACT followed by CCRT (investigational arm) or CCRT alone (control arm). Both arms were treated with 80 mg/m(2) cisplatin every 3 weeks concurrently with radiotherapy. The investigational arm received cisplatin (80 mg/m(2) dl) and fluorouracil (800 mg/m(2) civ dl-5) every 3 weeks for two cycles before CCRT. The primary end-point was disease-free survival (DFS) and distant metastasis-free survival (DMFS). Secondary end-point was overall survival (OS). Survival curves for the time-to-event endpoints were analyzed by the Kaplan-Meier method and compared using the log-rank test. The P value was calculated using the 5-year endpoints.Results: Four hundred seventy six patients were randomly assigned to the investigational (n = 238) and control arms (n = 238). The investigational arm achieved higher 3-year DFS rate (82.0%, 95% CI = 0.77-0.87) than the control arm (74.1%, 95% CI = 0.68 0.80, P = 0.028). The 3-year DMFS rate was 86.0% for the investigational arm versus 82.0% for the control arm, with marginal statistical significance (P = 0.056). However, there were no statistically significant differences in OS or locoregional relapse-free survival (LRRFS) rates between two arms (OS: 88.2% versus 88.5%, P = 0.815; LRRFS: 94.3% versus 90.8%, P = 0.430). The most common grade 3-4 toxicity during NACT was neutropenia (16.0%). During CCRT, the investigational arm experienced statistically significantly more grade 3-4 toxicities (P < 0.001).Conclusion: NACT improved tumour control compared with CCRT alone in locoregionally advanced NPC, particularly at distant sites. However, there was no early gain in OS. Longer follow-up is needed to determine the eventual therapeutic efficacy. (C) 2017 Elsevier Ltd. All rights reserved.