| 何依月,徐婧姝,毛一辰,等.诱导化疗联合PD-1抑制剂和尼妥珠单抗治疗局部晚期鼻咽癌的短期疗效和安全性[J].肿瘤学杂志,2026,32(6):503-510. |
| 诱导化疗联合PD-1抑制剂和尼妥珠单抗治疗局部晚期鼻咽癌的短期疗效和安全性 |
| Short-Term Efficacy and Safety of Induction Chemotherapy Plus PD-1 Inhibitors and Nimotuzumab for Locoregionally Advanced Nasopharyngeal Carcinoma |
| 投稿时间：2026-01-21 |
| DOI：10.11735/j.issn.1671-170X.2026.06.B008 |
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| 中文关键词: 鼻咽肿瘤 局部晚期 PD-1抑制剂 尼妥珠单抗 诱导化疗 客观缓解率 不良事件 |
| 英文关键词:nasopharyngeal neoplasms locoregionally advanced PD-1 inhibitor nimotuzumab induction chemotherapy objective response rate adverse event |
| 基金项目:国家自然科学基金（82172804）；江苏省卫生健康委重点项目（K2019028）；南京市科技计划项目（2022SX00001663）；南京医科大学鼻咽癌专病队列研究（NMUC2021011A） |
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| 中文摘要: |
| 摘 要：［目的］ 探讨诱导化疗联合程序性死亡受体1（programmed death protein-1，PD-1）抑制剂和尼妥珠单抗治疗局部晚期鼻咽癌的短期疗效及安全性。［方法］ 回顾性分析2023年1月至2023年12月江苏省肿瘤医院收治的104例局部晚期鼻咽癌患者的临床资料。根据诱导治疗方案分为单纯诱导化疗（induction chemotherapy）组（IC组，74例）和诱导化疗联合PD-1抑制剂和尼妥珠单抗（induction chemotherapy+ PD-1 inhibitors and nimotuzumab）组（ICIT组，30例）。采用倾向评分匹配（propensity score matching，PSM）平衡两组基线特征后，纳入匹配队列60例，其中IC组30例，ICIT组30例。依据实体瘤疗效评价标准1.1版评估近期疗效，并比较两组治疗相关不良事件发生情况。采用多因素Logistic回归分析诱导治疗后客观缓解率（objective response rate，ORR）的影响因素。［结果］ PSM队列中，诱导治疗结束后，ICIT组ORR显著高于IC组（100.0% vs 80.0%，P=0.024），IC组完全缓解（complete response，CR）2例，部分缓解（partial response，PR）22例，疾病稳定（stable disease，SD）6例，ICIT组分别为5、25、0例。同步放化疗结束后3个月，两组ORR均为100.0%，但ICIT组CR率高于IC组（93.3% vs 70.0%，P=0.042）。多因素Logistic回归分析显示，年龄≥60岁与诱导治疗后ORR降低相关［比值比（odds ratio，OR）=0.26，95%置信区间（confidence interval，CI）：0.07～0.91，P=0.042］。安全性方面，两组3～4级不良事件总体发生率相近；ICIT组3～4级口腔黏膜炎发生率高于IC组（40.0% vs 16.7%），但差异无统计学意义（P=0.084）。［结论］ 在局部晚期鼻咽癌中，诱导化疗联合PD-1抑制剂和尼妥珠单抗的三联诱导治疗可在不显著增加严重毒性的前提下，提高诱导期ORR并减少SD，为后续放疗提供更有利的起点，具有一定的临床应用价值。 |
| 英文摘要: |
| Abstract：［Objective］ To investigate the short-term efficacy and safety of induction chemotherapy plus programmed death protein-1(PD-1) inhibitors and nimotuzumab in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). ［Methods］ Clinical data of 104 patients with locoregionally advanced NPC treated at Jiangsu Cancer Hospital from January 2023 to December 2023 were retrospectively analyzed. According to the induction regimen， patients were divided into an induction chemotherapy alone group(IC group， n=74) and an induction chemotherapy plus PD-1 inhibitors and nimotuzumab group(ICIT group， n=30). After propensity score matching (PSM) to balance baseline characteristics， a matched cohort of 60 patients (30 in each group) was obtained. Short-term response was evaluated according to RECIST version 1.1， and treatment-related adverse events were compared between the two groups. Multivariate Logistic regression analysis was performed to identify factors associated with objective response rate(ORR) after induction therapy. ［Results］ In the PSM cohort， after induction therapy， the ORR in the ICIT group was significantly higher than that in the IC group (100.0% vs 80.0%， P=0.024). In the IC group， 2 patients achieved complete response (CR)， 22 partial response(PR)， and 6 stable disease (SD)； the corresponding numbers in the ICIT group were 5， 25， and 0， respectively. At 3 months after concurrent chemoradiotherapy， the ORR was 100.0% in both groups， whereas the CR rate in the ICIT group was higher than that in the IC group(93.3% vs 70.0%， P=0.042). Multivariate Logistic regression analysis showed that age ≥ 60 years old was associated with a lower ORR after induction therapy［odds ratio(OR)=0.26，95% confidence interval(CI)：0.07～0.91，P=0.042］. Regarding safety， the overall incidence of grade 3~4 adverse events was similar between the two groups. The incidence of grade 3~4 oral mucositis was higher in the ICIT group than that in the IC group (40.0% vs 16.7%)， but the difference was not statistically significant (P=0.084). ［Conclusion］ In patients with locoregionally advanced NPC， induction chemotherapy combined with PD-1 inhibitors and nimotuzumab significantly improves ORR and reduces SD after induction therapy without a substantial increase in severe toxicity， thereby providing a more favorable starting point for subsequent radiotherapy and demonstrating potential clinical value. |
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