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| 抗PD-1抑制剂联合尼妥珠单抗及诱导化疗治疗局晚期鼻咽癌的短期疗效及安全性分析 |
| Short-term efficacy and safety of anti–PD-1 inhibitors combined with nimotuzumab and induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma |
| 投稿时间：2026-01-21 修订日期：2026-03-12 |
| DOI： |
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| 中文关键词: 鼻咽癌 局部晚期 抗PD-1抑制剂 尼妥珠单抗 诱导化疗 客观缓解率 |
| 英文关键词:HE Yiyue1,2, XU Jingshu1,2, MAO Yichen2, ZONG Dan2, HE Xia1,2 |
| 基金项目:国家自然科学(82172804)；江苏省卫健委重点项目(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: |
| 目的 探讨抗PD-1抑制剂联合尼妥珠单抗及诱导化疗(ICIT)在局晚期鼻咽癌(LANPC)中的短期疗效及安全性,重点评估其对诱导期客观缓解率(ORR)的影响。方法 回顾性分析2023年1月至2023年12月于江苏省肿瘤医院接受诱导治疗的104例LANPC患者,根据诱导方案分为单纯诱导化疗组(IC组,n=74)和诱导化疗联合PD-1抑制剂及尼妥珠单抗组(ICIT组,n=30)。采用倾向评分匹配方法平衡主要基线特征,构建匹配队列(IC组30例,ICIT组30例)。依据RECIST 1.1评价近期疗效,并比较两组不良反应发生情况。结果 在匹配队列中,诱导治疗结束后ICIT组ORR为100.0%,显著高于IC组的80.0%(p=0.024),其差异主要来源于ICIT组未观察到疾病稳定(SD)。同步放化疗完成后3个月,两组ORR均达到100.0%,但ICIT组完全缓解(CR)比例更高(93.3% vs 70.0%,p=0.042)。安全性方面,两组总体耐受性良好,严重(3–4级)不良反应发生率相近；ICIT组3–4级口腔黏膜炎发生率略有升高,但整体可管理,未见不可控免疫相关严重不良事件。结论 在局晚期鼻咽癌中,抗PD-1抑制剂联合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: |
| Objective: To investigate the short-term efficacy and safety of induction chemotherapy combined with a PD-1 inhibitor and nimotuzumab (ICIT) in patients with locoregionally advanced nasopharyngeal carcinoma (LANPC), with a particular focus on its impact on the objective response rate (ORR) after induction therapy.Methods: This retrospective study included 104 patients with LANPC who received induction treatment at Jiangsu Cancer Hospital between January and December 2023. According to the induction regimen, patients were divided into an induction chemotherapy alone group (IC group, n = 74) and an induction chemotherapy combined with a PD-1 inhibitor and nimotuzumab group (ICIT group, n = 30). Propensity score matching was performed to balance major baseline characteristics, resulting in a matched cohort of 30 patients in each group. Tumor response was evaluated according to RECIST version 1.1, and treatment-related adverse events were compared between the two groups. Results: In the matched cohort, the ORR after induction therapy was 100.0% in the ICIT group, which was significantly higher than that in the IC group (80.0%, p = 0.024). This difference was mainly attributable to the absence of stable disease (SD) in the ICIT group. At 3 months after completion of concurrent chemoradiotherapy, the ORR reached 100.0% in both groups; however, the complete response (CR) rate was significantly higher in the ICIT group (93.3% vs. 70.0%, p = 0.042). Regarding safety, the overall tolerability was comparable between the two groups, with similar incidences of grade 3–4 adverse events. The ICIT group showed a higher incidence of grade 3–4 oral mucositis, which was manageable, and no uncontrollable severe immune-related adverse events were observed. Conclusion: In patients with locoregionally advanced nasopharyngeal carcinoma, induction chemotherapy combined with a PD-1 inhibitor and nimotuzumab can significantly improve the ORR and reduce SD without a substantial increase in severe toxicity, providing a more favorable starting point for subsequent radiotherapy and demonstrating potential clinical value. |
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