替吉奥维持干预在转移性鼻咽癌治疗中的时机优势研究

目的:通过与转移性鼻咽癌进展后二线治疗模式的生存预后比较,明确转移性鼻咽癌一线治疗后替吉奥(S-1)维持干预治疗的时机优势。方法:一线化疗临床获益的转移性鼻咽癌患者,1∶2分层随机为研究组(维持干预组,S-1维持至疾病进展或不能耐受)和对照组(延迟干预组),评价S-1及时维持干预在改善转移性鼻咽癌整体预后中的时机优势。结果:至2019年5月入组157例患者,中位随访20.2月(8.0~53.1月)。可评价病例143例:维持干预组51例,延迟干预组92例。与延迟干预组比较,S-1维持干预提高转移性鼻咽癌一线化疗后的中位首次无疾病进展生存期(mfPFS)(8.4月vs 16.0月,P<0.001)及全程无疾病进展生存期(mtPFS)(14.8月vs 16.0月,P=0.006);并显著改善患者中位总生存(mOS)(21.1月vs 27.5月,P=0.003);亚组分析,转移性鼻咽癌一线化疗后及时的S-1维持干预与延迟干预比较,S-1维持干预显著延长mtPFS(16.0月vs 14.8月、13.3月,P=0.004)及mOS(27.5月vs 23.4月、19.6月,P<0.001)。维持干预组耐受性良好,不良反应主要表现为1级的皮肤色素沉着、口腔黏膜炎、手足综合征、恶心等,经过方案调整或短期治疗延迟(<2周),患者均可耐受。结论:转移性鼻咽癌一线化疗后及时进行替吉奥维持干预比延迟干预明显改善转移性鼻咽癌患者生存预后,患者耐受性良好。

Study on the timing advantage of S-1 maintenance intervention in the treatment of metastatic nasopharyngeal carcinoma

Objective:Compared with the survival prognosis of the second-line treatment mode after the progression of metastatic nasopharyngeal carcinoma,the timing advantage of S-1 for maintaining intervention after first-line treatment of metastatic nasopharyngeal carcinoma was clarified.Methods:Patients with metastatic nasopharyngeal carcinoma who benefit from first-line chemotherapy were randomly divided into study group (maintenance intervention group,S-1 maintained until disease progression or intolerable) and control group (delayed intervention group) in a 1∶2 stratified manner.The timing advantage of S-1 timely maintenance intervention in improving the overall prognosis of metastatic nasopharyngeal carcinoma was evaluated.Results:Up to may 2019,157 patients were enrolled,with a median follow-up of 20.2 months (8.0~53.1 months).There were 143 evaluable cases:51 in the maintenance intervention group and 92 in the delayed intervention group.Compared with the delayed intervention group,S-1 maintenance intervention improved the median first time progression free survival (mfPFS) (8.4 months vs 16.0 months,P＜0.001) and the whole course progression free survival (mtPFS) (14.8 months vs 16.0 months,P=0.006)for metastatic nasopharyngeal carcinoma.Median overall survival (mOS) was significantly improved (21.1 vs 27.5 months,P=0.003).Subgroup analysis showed that S-1 maintenance intervention significantly prolonged mtPFS (16.0 months vs 14.8 months vs 13.3 months,P=0.004) and mOS (27.5 months vs 23.4 months vs 19.6 months,P＜0.001).Compared with delayed intervention after first-line chemotherapy for metastatic nasopharyngeal carcinoma.The adverse reactions in the maintenance intervention group were mainly grade 1 skin pigmentation,oral mucositis,hand foot syndrome,nausea,etc.which could be tolerated after the adjustment of the regimen or short-term treatment delay (<2 weeks).Conclusion:The survival prognosis of patients with metastatic nasopharyngeal carcinoma is significantly improve by timely S-1 maintenance intervention after first-line chemotherapy compare with delay intervention,and the patients are well tolerate.