近日，中山大学癌症防治中心毛燕萍团队研究了鼻咽癌咽后内侧淋巴结区规避放疗的疗效与安全性。2026年3月31日，《英国医学杂志》发表了这一成果。

为了评估避开内侧咽后淋巴结区放疗对于非转移性鼻咽癌的预设长期疗效（生存率与吞咽功能）及安全性，2017年11月20日至2018年12月3日期间，研究组在中国三家医学中心进行了一项开放标签、非劣效性、多中心、随机III期试验的预设五年分析。参与者为未经治疗、非角化型、非转移性且无内侧咽后淋巴结受累的鼻咽癌成人患者（18-65岁）。

研究组将符合条件的患者按1:1随机分组（区组大小为4），分别接受内侧咽后淋巴结区规避放疗或标准放疗。随机化按研究中心和治疗模式（单纯放疗、同步放化疗、或诱导化疗联合放疗/同步放化疗）进行分层。主要结局为局部无复发生存期。此前已报道用于评估内侧咽后淋巴结区规避放疗对比标准放疗非劣效性（非劣效界值为8%）的三年局部无复发生存期。此次更新报告重点关注五年生存率、毒性和生活质量。此外，采用电视荧光吞咽检查和咽缩肌的磁共振成像测量值作为吞咽困难的客观指标。

该试验共纳入内侧咽后淋巴结区规避组285例患者，标准组283例患者。中位随访70个月时，规避组与标准组的五年局部无复发生存率相似（89.2%（95%置信区间 85%～92%） vs. 90.6%（87%～94%）；分层风险比1.03（95%置信区间0.61～1.74）；P=0.90），总生存率亦相似（89.2%（85%～93%） vs. 90.3%（87%～94%）；分层风险比1.06（0.68～1.68）；P=0.79）。规避组的更新安全性数据显示，其≥1级吞咽困难发生率（45/206（22%） vs. 70/216（32%）；P=0.01）和≥2级口干发生率（33/206（16%） vs. 55/216（25%）；P=0.02）更低，吞咽相关生活质量更优（均值差 –11.9；P<0.001）。电视荧光吞咽检查显示，规避组在会厌谷残留（49/66（74%） vs. 62/62（100%）；P<0.001）、梨状窝残留（32/66（48%） vs. 45/62（73%）；P=0.01）、咽壁涂布（7/66（11%） vs. 17/62（27%）；P=0.01）、咽传输时间>1.0秒（1/66（2%） vs. 7/62（11%）；P=0.03）以及误吸（8/66（12%） vs. 18/62（29%）；P=0.03）方面的发生率均较低。此外，磁共振成像可检测到的晚期咽上缩肌（平均厚度：1.80 vs. 1.65 mm；P=0.005）和咽中缩肌（2.34 vs. 2.15 mm；P=0.01）萎缩在内侧咽后淋巴结区规避放疗后较轻。

研究结果表明，内侧咽后淋巴结区规避放疗通过减少对咽缩肌的放射性损伤，在保持疗效不受影响的同时，改善了远期吞咽功能，支持其作为非转移性鼻咽癌的标准治疗方案。

附：英文原文

Title: Medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial

Author: Shun-Xin Wang, Ya-Lan Tao, Tian-Sheng Gao, Ning Zhang, Guan-Qun Zhou, Fang-Yun Xie, Yuan Zhang, Rui Guo, Yi Yang, Yong-Jie Li, Shao-Qiang Liang, Yue-Can Zeng, Li Lin, Wen-Fei Li, Xu Liu, Cheng Xu, Yu-Pei Chen, Jia-Wei Lv, Li-Zhi Liu, Hao-Jiang Li, Ji-Bin Li, Hong-Mei Wen, Ying Sun, Ling-Long Tang, Xiao-Yu Liang, Jun Ma, Yan-Ping Mao

Issue&Volume: 2026/03/31

Abstract:

Objective To determine the pre-specified long term efficacy (survival and swallowing function) and safety of medial retropharyngeal lymph node (MRLN) region sparing radiotherapy for non-metastatic nasopharyngeal carcinoma.

Design Pre-specified five year analysis of an open label, non-inferiority, multicentre, randomised phase 3 trial.

Setting Three Chinese medical centres between 20 November 2017 and 3 December 2018.

Participants Adults (18-65 years) with untreated, non-keratinising, non-metastatic nasopharyngeal carcinoma without MRLN involvement.

Interventions Eligible patients were randomised (1:1; block size of four) to MRLN sparing radiotherapy or standard radiotherapy. Randomisation was stratified by institution and treatment modality (radiotherapy alone, concurrent chemoradiotherapy, or induction chemotherapy plus radiotherapy or concurrent chemoradiotherapy).

Main outcome measures The primary outcome was local relapse-free survival. The three year local relapse-free survival to assess the non-inferiority, with a margin of 8%, of MRLN sparing radiotherapy compared with standard radiotherapy has been reported previously. This updated report focuses on five year survival, toxicity, and quality of life. Additionally, a videofluoroscopic swallowing study and magnetic resonance imaging (MRI) measurements of pharyngeal contractors were used as objective measures of dysphagia

Results This trial enrolled 285 patients in the MRLN sparing group and 283 patients in the standard group. At a median follow-up of 70 months, the MRLN sparing and standard groups had similar five year local relapse-free survival (89.2% (95% confidence interval (CI) 85% to 92%) versus 90.6% (87% to 94%); stratified hazard ratio 1.03 (95% CI 0.61 to 1.74); P=0.90) and overall survival (89.2% (85% to 93%) versus 90.3% (87% to 94%); stratified hazard ratio 1.06 (0.68 to 1.68); P=0.79). Updated safety profiles of the MRLN sparing group showed a lower rate of grade ≥1 dysphagia (45/206 (22%) v 70/216 (32%); P=0.01) and grade ≥2 dry mouth (33/206 (16%) v 55/216 (25%); P=0.02) and enhanced swallowing related quality of life (mean difference –11.9; P<0.001). Videofluoroscopy showed a lower prevalence of vallecular residue (49/66 (74%) v 62/62 (100%); P<0.001), pyriform sinus residue (32/66 (48%) v 45/62 (73%); P=0.01), coating of pharyngeal wall (7/66 (11%) v 17/62 (27%); P=0.01), pharyngeal transit time >1.0 s (1/66 (2%) v 7/62 (11%); P=0.03), and aspiration (8/66 (12%) v 18/62 (29%); P=0.03) in the MRLN sparing group. Additionally, MRI detectable late atrophy in the superior pharyngeal constrictor (mean thickness: 1.80 v 1.65 mm; P=0.005) and middle pharyngeal constrictor (2.34 v 2.15 mm; P=0.01) was less severe after MRLN sparing radiotherapy.

Conclusions MRLN sparing radiotherapy maintained uncompromised efficacy and better long term swallowing function by reducing radiation damage to pharyngeal contractors, supporting its use as a standard of care for non-metastatic nasopharyngeal carcinoma.

DOI: 10.1136/bmj-2025-086050

Source: https://www.bmj.com/content/392/bmj-2025-086050