| 转移性鼻咽癌一线化疗后替吉奥维持治疗的多中心随机对照研究 |
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| 引用本文： | 杨慧,陆颖,黄海欣,胡晓桦,黄昌杰,刘美莲,冯献斌.转移性鼻咽癌一线化疗后替吉奥维持治疗的多中心随机对照研究[J].中国肿瘤临床,2021,48(1):25-29. |
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| 作者姓名： | 杨慧 陆颖 黄海欣 胡晓桦 黄昌杰 刘美莲 冯献斌 |
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| 作者单位： | ①.广西医科大学第四附属医院肿瘤科（广西壮族自治区柳州市545000） |
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| 基金项目： | 广西自然科学基金项目(编号:2017GXNSFBA198005);广西壮族自治区卫生健康委员会自筹经费科研项目(编号:Z20200837);广西壮族自治区卫生与计划生育委员会自筹经费科研项目(编号:Z2016167);柳州市科技计划项目(编号:2019AF10601);柳州市科技计划项目(编号:2018BJ10303);柳州市科学研究与技术开发计划(编号:2016G020203)资助。 |
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| 摘 要： | 目的 探讨转移性鼻咽癌一线化疗后替吉奥（S-1）维持治疗的有效性、安全性及获益的分子标志物，为延长转移性鼻咽癌患者无进展生存期（progression-free survival，PFS）提供新选择。 方法 选取2016年1月至2019年5月就诊于广西医科大学第四附属医院、广西医科大学第一附属医院、南宁市第二人民医院、桂林医学院附属医院、柳州市中医医院的一线化疗（CT）临床获益的转移性鼻咽癌患者，依照1 :1分层随机分为替吉奥维持治疗组（CT+S1）和观察组（CT），评价维持治疗的安全性及PFS获益。分析血浆EB病毒DNA（EBV-DNA）及血清淀粉样蛋白A（SAA）治疗后变化与维持治疗获益的相关性。 结果 本研究入组203例患者，中位随访时间19.8（6.1~51.3）个月，经一线化疗临床获益的可评价病例183例，其中CT+S1组88例，CT组95例。与CT组比较，CT+S1组患者的中位PFS（median PFS，mPFS）显著延长（16.2个月vs. 8.7个月，P < 0.001）。CT组中位替吉奥干预14（4~58）个疗程，主要不良反应为1级皮肤色素沉着、口腔黏膜炎、手足综合征、恶心等，经方案调整或短期治疗延迟（< 2周）患者均可耐受。入组患者EBV-DNA、SAA监测提示，一线化疗后EBV-DNA未下降至0或SAA仍有持续下降的患者可以从后续干预治疗中获益，48.5%（32/66）的患者在后续的干预治疗中出现上述指标的持续下降。仍有可评价病灶的51.2%（44/86）患者出现病灶的进一步缓解。 结论 一线化疗后的替吉奥维持治疗可改善转移性鼻咽癌患者的PFS，通过合理的用药方案调整，患者耐受性良好。血浆EBV-DNA、SAA持续下降、影像学残留的患者可能从维持治疗中获得更为显著的临床获益。
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| 关 键 词： | 转移性鼻咽癌 一线化疗 替吉奥 维持治疗 预后因素 |
| 收稿时间： | 2020-09-09 |
S-1 maintenance therapy after first-line chemotherapy for metastatic nasopharyngeal carcinoma:a multicenter,randomized,controlled study |
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| Hui Yang,Ying Lu,Haixin Huang,Xiaohua Hu,Changjie Huang,Meilian Liu,Xianbin Feng.S-1 maintenance therapy after first-line chemotherapy for metastatic nasopharyngeal carcinoma:a multicenter,randomized,controlled study[J].Chinese Journal of Clinical Oncology,2021,48(1):25-29. |
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| Authors: | Hui Yang Ying Lu Haixin Huang Xiaohua Hu Changjie Huang Meilian Liu Xianbin Feng |
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| Affiliation: | ①.Department of Oncology, The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou 545000, China②.Department of Oncology, the First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China③.Department of Oncology, the Second People's Hospital of Nanning, Nanning 530031, China④.Department of Radiotherapy, the Affiliated Hospital of Guilin Medical College, Guilin 541001, China⑤.Department of Oncology, Liuzhou Traditional Chinese Medical Hospital, Liuzhou 545001, China |
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| Abstract: | Objective:To explore the safety efficacy and prognostic factors for maintenance treatment with S-1 following first-line chemotherapy(CT)for metastatic nasopharyngeal carcinoma,and to provide a new option for prolonging progression-free survival(PFS)in patients.Methods:Patients enrolled in The Fourth Affiliated Hospital of Guangxi Medical University,The First Affiliated Hospital of Guangxi Medical University,the Second People's Hospital of Nanning,The Affiliated Hospital of Guilin Medical College,Liuzhou Traditional Chinese Medical Hospital from January 2016 to May 2019 with metastatic nasopharyngeal carcinoma who had clinically benefited from first-line CT were randomized and stratified in a 1:1 ratio to the maintenance group(CT+S1)or observation group(CT)to evaluate the safety of and PFS benefit from the maintenance treatment.The correlations of post-treatment changes in plasma EB virus DNA(EBV-DNA)and serum amyloid A(SAA)with benefit from maintenance treatment were analyzed.Results:In total,203 patients were enrolled,with the median(range)follow-up duration of 19.8(6.1-51.3)months.Among them,183 evaluable patients had clinically benefited from first-line chemotherapy,including 88 in CT+S1 group and 95 in CT group.Compared with that in CT group,the median PFS of patients in CT+S1 group was significantly prolonged(16.2 months vs.8.7 months,P<0.001).In the maintenance group,patients received a median(range)of 14(4-58)cycles of S1 treatment;the primary adverse reactions were Grade 1 skin pigmentation,oral mucositis,hand-foot syndrome,and nausea,and all patients tolerated the treatment well with dose modification or interruption(for<2 weeks).EBV-DNA and SAA monitoring revealed that patients whose EBV-DNA had not decreased to 0 or whose SAA continued to decrease following first-line chemotherapy could benefit from the subsequent intervention,with these indicators continuing to decrease in 48.5%(32/66)of patients.Among patients in whom evaluable lesions remained,51.2%(44/86)experienced further remission of lesions.Conclusions:Maintenance treatment with S-1 following first-line chemotherapy could improve the PFS of patients with metastatic nasopharyngeal carcinoma,and the patients could tolerate the treatment well with reasonable adjustment of the dosing schedule.Patients with continuous decreases in plasma EBV-DNA and SAA and residual lesions in imaging could derive more significant clinical benefits from the maintenance treatment. |
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| Keywords: | metastatic nasopharyngeal carcinoma first-line chemotherapy S-1 maintenance treatment prognostic factor |
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