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<p>Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) is the standard treatment for locoregionally advanced nasopharyngeal carcinoma (LA-NPC); however, patients with a suboptimal response to IC, defined as detectable Epstein–Barr virus DNA and/or stable or progressive disease after IC, remain at high risk of treatment failure. Here we report an open-label, randomised, phase 2 trial evaluating whether adding nimotuzumab, a humanised anti–epidermal growth factor receptor antibody, to CCRT improves outcomes in this high-risk population. A total of 246 patients with untreated, non-keratinising, stage II–IVA LA-NPC were randomly assigned (1:1) to receive CCRT with or without nimotuzumab. The primary endpoint was 2-year progression-free survival (PFS); secondary endpoints included overall survival, distant metastasis–free survival, locoregional relapse–free survival, short-term response rate, and safety. At a median follow-up of 47 months, the 2-year PFS was 81.0% (90% confidence interval [CI], 74.3–86.1) in the nimotuzumab plus CCRT group and 80.8% (90% CI, 74.2–85.7) in the CCRT-alone group (hazard ratio, 0.93 [90% CI, 0.63–1.37]; p = 0.70). Survival outcomes were similar between groups, while low-grade rash occurred more frequently with nimotuzumab. These findings indicate that adding nimotuzumab to CCRT does not improve survival in patients with LA-NPC with a suboptimal response to IC, underscoring the need for predictive biomarkers and alternative therapeutic strategies. Trial registration: NCT04223024.</p>

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Concurrent chemoradiotherapy plus nimotuzumab versus chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma with a suboptimal response to induction chemotherapy: a randomized phase 2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月31日

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  • Li-Ting Liu,
  • Xue-Song Sun,
  • Ting-Ting Quan,
  • Xiao-Yun Li,
  • Ling Guo,
  • Hao-Yuan Mo,
  • Shan-Shan Guo,
  • Sai-Lan Liu,
  • Ying Huang,
  • Dong-Hua Luo,
  • Rui Sun,
  • Guo-Dong Jia,
  • Ji-Bin Li,
  • Qing Liu,
  • Pan Wang,
  • Yu-Jing Liang,
  • Jie Chen,
  • Yi-Fu Li,
  • Hui Cheng,
  • Wei-Xiong Xia,
  • Fang Qiu,
  • Jin-Hao Yang,
  • Qi Yang,
  • Dong-Xiang Wen,
  • Jin-Jie Yan,
  • Chong Zhao,
  • Qiu-Yan Chen,
  • Lin-Quan Tang,
  • Hai-Qiang Mai

摘要

Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) is the standard treatment for locoregionally advanced nasopharyngeal carcinoma (LA-NPC); however, patients with a suboptimal response to IC, defined as detectable Epstein–Barr virus DNA and/or stable or progressive disease after IC, remain at high risk of treatment failure. Here we report an open-label, randomised, phase 2 trial evaluating whether adding nimotuzumab, a humanised anti–epidermal growth factor receptor antibody, to CCRT improves outcomes in this high-risk population. A total of 246 patients with untreated, non-keratinising, stage II–IVA LA-NPC were randomly assigned (1:1) to receive CCRT with or without nimotuzumab. The primary endpoint was 2-year progression-free survival (PFS); secondary endpoints included overall survival, distant metastasis–free survival, locoregional relapse–free survival, short-term response rate, and safety. At a median follow-up of 47 months, the 2-year PFS was 81.0% (90% confidence interval [CI], 74.3–86.1) in the nimotuzumab plus CCRT group and 80.8% (90% CI, 74.2–85.7) in the CCRT-alone group (hazard ratio, 0.93 [90% CI, 0.63–1.37]; p = 0.70). Survival outcomes were similar between groups, while low-grade rash occurred more frequently with nimotuzumab. These findings indicate that adding nimotuzumab to CCRT does not improve survival in patients with LA-NPC with a suboptimal response to IC, underscoring the need for predictive biomarkers and alternative therapeutic strategies. Trial registration: NCT04223024.