Anti-PD-1 antibody with or without capecitabine as maintenance therapy after first-line therapy of recurrent or metastatic nasopharyngeal carcinoma

Yi-Fu Li; Yu Chen; Hui Cheng; Jia-Yi Shen; Bo-Wen Shen; Hao-Xiang Long; Xue-Song Sun; Jie Chen; Jing-Yun Peng; Pan Wang; Shan-Shan Guo; Qiu-Yan Chen; Lin-Quan Tang; Hai-Qiang Mai; Li-Ting Liu

doi:10.1093/oncolo/oyaf188

Anti-PD-1 antibody with or without capecitabine as maintenance therapy after first-line therapy of recurrent or metastatic nasopharyngeal carcinoma

Oncologist. 2025 Jun 27:oyaf188. doi: 10.1093/oncolo/oyaf188. Online ahead of print.

Authors

Yi-Fu Li^{1

2}, Yu Chen^{1

2}, Hui Cheng^{1

2}, Jia-Yi Shen^{1

3}, Bo-Wen Shen^{1

2}, Hao-Xiang Long^{1

2}, Xue-Song Sun^{1

2}, Jie Chen^{1

2}, Jing-Yun Peng^{1

2}, Pan Wang^{1

2}, Shan-Shan Guo^{1

2}, Qiu-Yan Chen^{1

2}, Lin-Quan Tang^{1

2}, Hai-Qiang Mai^{1

2}, Li-Ting Liu^{1

2}

Affiliations

¹ 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.
² Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, P. R. China.
³ Department of Anesthesiology, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

PMID: 40577355
DOI: 10.1093/oncolo/oyaf188

Abstract

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 = 0.0063). Subgroup analysis showed that patients with pre-treatment Epstein-Barr virus (EBV) DNA >12,400 copies/mL and undetectable post-treatment levels had significant improved PFS with combined maintenance therapy (hazard ratio [HR] = 0.44, 95% confidence interval [CI] = 0.20-0.96, P = 0.033). 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 = 0.17), or those with detectable post-treatment EBV DNA levels regardless of pre-treatment levels (HR = 0.73, 95% = CI 0.31-1.70, P = 0.46). Combined maintenance therapy was associated with higher rates of grade 3-4 hand-foot syndrome (P < 0.001) and leukopenia (P = 0.0487).

Conclusion: 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.

Keywords: Capecitabine; Nasopharyngeal Carcinoma; PD-1 Inhibitor; Palliative Care.