摘要
目的 探讨EBV-DNA、SAA与转移性鼻咽癌经一线化疗获益后使用替吉奥（S1）维持治疗疗效的相关性，为转移性鼻咽癌一线标准治疗后的个体化维持治疗策略提供思路。方法 2015年5月至2019年5月参与《替吉奥维持治疗一线化疗后转移性鼻咽癌多中心临床研究》的患者，1:1随机分为替吉奥维持治疗组（S1-MT）和非维持治疗组（non-MT），分析EBV-DNA及SAA状态与PFS、OS预后的相关性。结果 随访至2021年5月，中位随访时间24.3（6.1-59.8）月，共纳入183例可评价病例（S1-MT组88例，non-MT组95例）。与non-MT组比较，S1-MT显著延长中位PFS和中位OS（16.9月 vs. 9.3月，P<0.001；33.6月 vs. 20.6月，P<0.001），治疗耐受性良好。non-MT组，一线化疗后EBV-DNA阳性患者的PFS显著短于阴性患者(7.5 vs 10.5月，P<0.001)；而接受S1-MT治疗后，EBV-DNA阳性患者PFS改善与阴性患者无差异（P=0.358）。一线化疗后SAA持续下降患者，在non-MT组中，PFS和OS均显著低于SAA稳定患者(4.5 vs. 10.5月，P<0.001；14.8 vs. 23.6月，P<0.001）；S1-MT治疗显著改善SAA持续下降患者生存，PFS和OS与稳定患者比较均无显著差异（P=0. 292；P=0.051）。结论 S1维持治疗可改善一线化疗获益的转移性鼻咽癌患者的PFS和OS，耐受性良好。一线化后EBV-DNA阳性、SAA持续下降的患者可能从S1的维持治疗中获益。
关键词： 转移性鼻咽癌；替吉奥；维持治疗；EBV-DNA；SAA
Abstract
Objective: To explore the correlation between EBV-DNA, SAA and maintenance treatment with S-1 following first-line chemotherapy (CT) for metastatic nasopharyngeal carcinoma, and to provide reference for individualized treatment. Methods: Patients enrolled in A multicenter clinical study of Tiggio maintenance treatment for metastatic nasopharyngeal carcinoma after first-line chemotherapy from May 2015 to May 2019, the patients with metastatic nasopharyngeal carcinoma who had clinically benefited from first-line CT were randomly assigned centrally (1:1) to the maintenance group (S1-MT) or observation group (non-MT) ,and the correlation between plasma Epstein-Barr virus DNA (EBV-DNA), serum amyloid A (SAA) and progression-free survival (PFS) ,overall survival (OS) were analyzed. Results: Follow-up was performed until May 2021, there were 183 evaluable cases with a median follow-up time of 24.3 (6.1-59.8) months, including 88 cases in the S1-MT group and 95 cases in the non-MT group.Compared with the non-MT group, the median PFS and median OS of the S1-MT group were significantly prolonged (16.9 months vs. 9.3 months, P<0.001; 33.6 months vs. 20.6 months, P<0.001) . Ppatients tolerate S1 well.In the non-MT group, EBV-DNA-positive patients had significantly shorter PFS than EBV-DNA-negative patients after first-line chemotherapy (7.5 vs 10.5 months, P<0.001).However, after S1 treatment, the improvement of PFS in EBV-DNA positive patients was no different from that in EBV-DNA negative patients (P= 0.358).In the non-MT group, the mPFS of SAA- declining patients and SAA-stable patients were 4.5 and 10.5 months (P<0.001); mOS was 14.8 and 23.6 months (P<0.001), respectively. In the S1-MT group, there was no significant difference in mPFS and mOS between SAA- declining patients and SAA-stable patients (P=0.292; P=0.051). Conclusion : Maintenance treatment with S-1 following first-line chemotherapy could improve the PFS ad OS of patients with metastatic nasopharyngeal carcinoma, and the patients could tolerate the treatment well.Patients with positive EBV-DNA and continuous decline in SAA after first-line treatment can benefit more from S1 maintenance therapy.
Key words： Metastatic Nasopharyngeal Carcinoma, S-1, Maintenance Treatment, EBV-DNA, SAA
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