基于第九版TNM分期系统定义鼻咽癌的最佳治疗策略：来自流行区多中心队列研究的见解

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中文摘要

背景： 第九版AJCC/UICC分期系统（TNM-9）于2025年发布，促使需要重新定义循证治疗方案。本研究旨在确定新标准下的最佳治疗。
方法： 在这项多中心队列中，我们纳入了来自中国流行区（2016-2017年）的非转移性（M0）或初诊转移性（M1）鼻咽癌患者。倾向性评分匹配（1:1或1:M）和逆概率治疗加权最小化了选择偏倚。通过Kaplan-Meier和Cox模型比较生存。
结果： 该队列包括6049例按TNM-9标准重新分期的非转移性患者，分为以下风险组：低危（IA期）、中危（IB期和T3N0）、中高危（T3N1）和高危（T1-3N2和III期）。此外，纳入了127例初诊转移性患者。在IA期组中，同步放化疗（CCRT）与单纯调强放疗（IMRT）之间的生存无显著差异（风险比[HR]：0.50；95% CI：0.05-5.50；P = 0.562）。然而，在中危组中，CCRT显示出显著改善的5年OS（97.9% vs. 91.0%；P = 0.001）。在高危患者中，诱导化疗（IC）后接CCRT联合或不联合辅助化疗导致更优的5年OS（83.9% vs. 78.6%；P = 0.003）。尽管TNM-9下的重新分类仅影响有限数量的患者（n = 301），但该亚组从添加IC中表现出显著的生存获益（5年OS：83.2% vs. 66.4%；P = 0.001）。结合全身治疗、局部区域放疗（LRRT）和维持治疗（MT）的综合治疗策略与显著延长的生存相关（HR：0.36；95% CI：0.23-0.55；和HR：0.45，95% CI：0.25-0.79）。此外，M1a中转移灶的局部巩固治疗（LCT）与中位OS延长的非显著趋势相关（89.0 vs. 62.4个月；P = 0.122）。
结论： 在TNM-9下，管理建议如下：IA期采用根治性单纯IMRT；IB期和T3N0采用CCRT；高危疾病包括重新分类的亚组采用高强度治疗。对于转移性疾病，在全身治疗中添加LRRT和MT与M1a和M1b患者的生存改善相关，而仅在M1a亚组中观察到LCT潜在获益的趋势。

英文摘要

BACKGROUND: The ninth edition AJCC/UICC staging system (TNM-9) for nasopharyngeal carcinoma (NPC) was released in 2025, prompting a need to redefine evidence-based treatment regimens. This study aimed to identify optimal therapies under the new criteria.
METHODS: In this multicenter cohort, we enrolled patients from endemic Chinese regions (2016‑2017) with non‑metastatic (M0) or de novo metastatic (M1) NPC. Propensity score matching (1:1 or 1:M) and inverse probability of treatment weighting minimized selection bias. Survival was compared via Kaplan‑Meier and Cox models.
RESULTS: The cohort comprised 6049 non-metastatic patients restaged by TNM-9 criteria, categorized into the following risk groups: low-risk (stage IA), intermediate-risk (stage IB and T3N0), high-intermediate-risk (T3N1), and high-risk (T1-3N2 and stage III). Additionally, 127 de novo metastatic patients were enrolled. Survival between concurrent chemoradiotherapy (CCRT) and intensity-modulated radiotherapy (IMRT) alone in the stage IA group was not significantly different (hazard ratio [HR]: 0.50; 95% CI: 0.05-5.50; P = 0.562). However, within the intermediate-risk group, CCRT demonstrated significantly improved 5-year OS (97.9% vs. 91.0%; P = 0.001). Among high-risk patients, induction chemotherapy (IC) followed by CCRT with or without adjuvant chemotherapy resulted in superior 5-year OS (83.9% vs. 78.6%; P = 0.003). Although reclassification under TNM-9 affected only a limited number of patients (n = 301), this subgroup exhibited a substantial survival benefit from the addition of IC (5-year OS: 83.2% vs. 66.4%; P = 0.001). A comprehensive treatment strategy combining systemic therapy, locoregional radiotherapy (LRRT), and maintenance therapy (MT) was associated with significantly prolonged survival (HR: 0.36; 95% CI: 0.23-0.55; and HR: 0.45, 95% CI: 0.25-0.79). Furthermore, local consolidation therapy of metastases (LCT) in M1a was associated with a non-significant trend longer median OS (89.0 vs. 62.4 months; P = 0.122).
CONCLUSIONS: Under the TNM-9, management recommendations were as follows: radical IMRT alone for stage IA; CCRT for stage IB and T3N0; and high-intensity therapy for high-risk disease, including reclassified subsets. For metastatic disease, the addition of LRRT and MT to systemic therapy was associated with improved survival in both M1a and M1b patients, whereas a trend toward potential benefit from LCT was observed only in M1a subgroup.