He S-Q, Lv S-H, Wen S-Q, Wang L, Zhao Z-Y, Bei W-X, Huang Y, Xiang Y-Q, Liu G-Y
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
ESMO Open. 2025 Jun;10(6):105295. doi: 10.1016/j.esmoop.2025.105295. Epub 2025 Jun 3.
Chemoimmunotherapy followed by immunotherapy maintenance is recommended as the standard treatment for metastatic nasopharyngeal carcinoma (NPC) patients. While capecitabine maintenance therapy has been shown to improve outcomes in these patients, data on the efficacy of combining capecitabine with immunotherapy maintenance remain limited. This study compared the efficacy of immunotherapy combined with capecitabine maintenance therapy (Immu/Cape) versus immunotherapy maintenance alone (Immu) in patients with de novo metastatic NPC (dmNPC) who received first-line chemoimmunotherapy.
Patients with dmNPC receiving platinum-based chemoimmunotherapy were included in this study. Propensity score matching (PSM) analysis was employed to balance the baseline characteristics between the two treatment groups.
A total of 287 dmNPC patients were included in the study (100 in the Immu/Cape group and 187 in the Immu group). Patients in the Immu/Cape group demonstrated significantly prolonged progression-free survival (PFS; median PFS 41.5 versus 23.1 months, P < 0.001). After PSM, 83 patients remained in each group. Multivariable analysis indicated that the maintenance regimen was an independent prognostic factor for prolonged PFS (Immu/Cape versus Immu: hazard ratio 0.44, 95% confidence interval 0.26-0.73, P = 0.001). Subgroup analysis revealed that patients with polymetastatic disease (PMD) receiving Immu/Cape had significantly longer PFS compared with those receiving immunotherapy alone (3-year PFS rate: 49.2% versus 26.7%, P = 0.0087). In contrast, no significant benefit was observed in patients with oligometastatic disease (3-year PFS rate: 57.9% versus 54.2%, P = 0.27). Furthermore, in patients with detectable Epstein-Barr virus (EBV) DNA, the Immu/Cape group exhibited significantly higher 3-year PFS rates compared with the Immu group (34.0% versus 19.8%, P = 0.032), whereas no PFS advantage was noted in patients with undetectable EBV DNA (65.1% versus 52.6%, P = 0.13).
Immu/Cape maintenance therapy appears to be superior to immunotherapy alone in prolonging PFS in patients with dmNPC, particularly in those with PMD and detectable EBV DNA after two to six cycles of treatment.
化疗免疫疗法后序贯免疫疗法维持治疗被推荐为转移性鼻咽癌（NPC）患者的标准治疗方案。虽然卡培他滨维持治疗已被证明可改善这些患者的预后，但关于卡培他滨与免疫疗法维持联合应用疗效的数据仍然有限。本研究比较了免疫疗法联合卡培他滨维持治疗（免疫/卡培他滨组）与单纯免疫疗法维持治疗（免疫组）在接受一线化疗免疫疗法的初治转移性NPC（dmNPC）患者中的疗效。
本研究纳入接受铂类化疗免疫疗法的dmNPC患者。采用倾向评分匹配（PSM）分析来平衡两个治疗组之间的基线特征。
本研究共纳入287例dmNPC患者（免疫/卡培他滨组100例，免疫组187例）。免疫/卡培他滨组患者的无进展生存期（PFS）显著延长（中位PFS：41.5个月对23.1个月，P<0.001）。PSM后，每组各有83例患者。多变量分析表明，维持治疗方案是PFS延长的独立预后因素（免疫/卡培他滨组与免疫组：风险比0.44，95%置信区间0.26 - 0.73，P = 0.001）。亚组分析显示，与单纯接受免疫疗法的患者相比，接受免疫/卡培他滨治疗的多转移疾病（PMD）患者的PFS显著更长（3年PFS率：49.2%对26.7%，P = 0.0087）。相比之下，寡转移疾病患者未观察到显著获益（3年PFS率：57.9%对54.2%，P = 0.27）。此外，在可检测到爱泼斯坦 - 巴尔病毒（EBV）DNA的患者中，免疫/卡培他滨组的3年PFS率显著高于免疫组（34.0%对19.8%，P = 0.032），而在未检测到EBV DNA的患者中未观察到PFS优势（65.1%对52.6%，P = 0.13）。
免疫/卡培他滨维持治疗在延长dmNPC患者的PFS方面似乎优于单纯免疫疗法，尤其是在经过两至六个周期治疗后有PMD且可检测到EBV DNA的患者中。
