抗程序性死亡蛋白1（PD-1）抗体联合或不联合卡培他滨作为复发性或转移性鼻咽癌一线治疗后的维持治疗。
Anti-PD-1 antibody with or without capecitabine as maintenance therapy after first-line therapy of recurrent or metastatic nasopharyngeal carcinoma.
作者信息
Li Yi-Fu, Chen Yu, Cheng Hui, Shen Jia-Yi, Shen Bo-Wen, Long Hao-Xiang, Sun Xue-Song, Chen Jie, Peng Jing-Yun, Wang Pan, Guo Shan-Shan, Chen Qiu-Yan, Tang Lin-Quan, Mai Hai-Qiang, Liu Li-Ting
机构信息
State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P. R. China.
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou 510060, P. R. China.
出版信息
Oncologist. 2025 Jul 4;30(7). doi: 10.1093/oncolo/oyaf188.
BACKGROUND
The use of maintenance therapy for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) following first-line treatment with gemcitabine, cisplatin, and anti-PD-1 antibody remains controversial. Therefore, an effective and low-toxicity maintenance treatment option is urgently needed.
METHODS
This retrospective study included 301 patients who received either combined maintenance therapy (anti-PD-1 antibody plus capecitabine) or anti-PD-1 antibody alone. Patients were matched in a 1:3 ratio using propensity score matching (PSM). Progression-free survival (PFS) was the primary outcome, and its association with maintenance therapy was assessed using the log-rank test and Cox proportional hazards model.
RESULTS
Fifty-eight patients were included in the combined maintenance therapy group. After PSM, 174 patients were included in the anti-PD-1 antibody maintenance therapy group. In the matched cohort, the 2-year PFS rate was significantly higher in the combined maintenance therapy group than in the anti-PD-1 antibody monotherapy group (66.8% vs. 51.3%, P = .0063). Subgroup analysis showed that patients with pre-treatment Epstein-Barr virus (EBV) DNA > 12 400 copies/mL and undetectable post-treatment levels had significantly improved PFS with combined maintenance therapy (hazard ratio [HR] = 0.44, 95% confidence interval [CI] = 0.20-0.96, P = .033). In contrast, no statistically significant PFS improvement from the combined maintenance therapy was observed among patients with low pre-treatment EBV DNA (≤12 400 copies/mL) and undetectable post-treatment levels (HR = 0.59, 95% CI = 0.27-1.27, P = .17), or those with detectable post-treatment EBV DNA levels regardless of pre-treatment levels (HR = 0.73, 95% CI = 0.31-1.70, P = .46). Combined maintenance therapy was associated with higher rates of grade 3-4 hand-foot syndrome (P < .001) and leukopenia (P = .0487).
CONCLUSIONS
Anti-PD-1 antibody plus capecitabine maintenance therapy improved PFS with manageable toxicities in patients with RM-MPC following first-line immunochemotherapy, particularly in those with pre-treatment EBV DNA >12 400 copies/mL and undetectable post-treatment levels.
背景
对于接受吉西他滨、顺铂和抗程序性死亡蛋白1（PD-1）抗体一线治疗后的复发或转移性鼻咽癌（RM-NPC）患者，维持治疗的应用仍存在争议。因此，迫切需要一种有效且低毒的维持治疗方案。
方法
这项回顾性研究纳入了301例接受联合维持治疗（抗PD-1抗体加卡培他滨）或单纯抗PD-1抗体治疗的患者。采用倾向评分匹配（PSM）以1:3的比例对患者进行匹配。无进展生存期（PFS）是主要观察指标，使用对数秩检验和Cox比例风险模型评估其与维持治疗的相关性。
结果
联合维持治疗组纳入58例患者。PSM后，抗PD-1抗体维持治疗组纳入174例患者。在匹配队列中，联合维持治疗组的2年PFS率显著高于抗PD-1抗体单药治疗组（66.8%对51.3%，P = 0.0063）。亚组分析显示，治疗前爱泼斯坦-巴尔病毒（EBV）DNA>12400拷贝/mL且治疗后检测不到的患者，联合维持治疗可显著改善PFS（风险比[HR]=0.44，95%置信区间[CI]=0.20-0.96，P = 0.033）。相比之下，治疗前EBV DNA较低（≤12400拷贝/mL）且治疗后检测不到的患者，或无论治疗前水平如何治疗后EBV DNA可检测到的患者，联合维持治疗未观察到PFS有统计学意义的改善（HR = 0.59，95% CI = 0.27-1.27，P = 0.
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