R-FPD方案治疗初治原发中枢神经系统淋巴瘤的前瞻性研究  

Prospective study of preliminarily diagnosed primary central nervous system lymphoma treated with an R-FPD regimen

作　　者：高凤华 张旭东[1] 张明智[1] 吴晶晶[1] Fenghua Gao;Xudong Zhang;Mingzhi Zhang;Jingjing Wu(Department of Oncology,The First Affiliated Hospital of Zhengzhou University,Lymphoma Diagnosis and Treatment Center,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院肿瘤科,河南省淋巴瘤诊疗中心,郑州市450052

出　　处：《中国肿瘤临床》2020年第9期454-459,共6页Chinese Journal of Clinical Oncology

基　　金：河南省自然科学基金项目(编号:162300410304)资助。

摘　　要：目的:评估利妥昔单抗联合福莫司汀、培美曲塞、地塞米松方案(R-FPD)治疗原发中枢神经系统淋巴瘤(primary central nervous system lymphoma,PCNSL)的安全性、有效性和可行性,初步探索生物标志物在PCNSL治疗中的意义。方法:本研究为前瞻性、单中心、单臂Ⅱ期临床试验。分析2018年7月至2019年7月郑州大学第一附属医院确诊的初治PCNSL患者。全组患者均接受R-FPD方案一线化疗。主要研究终点为客观缓解率(objective response rate,ORR),疾病控制率(disease control rate,DCR),无进展生存期(progression free survival,PFS),总生存期(overall survival,OS)。次要研究终点为不良反应(adverse reaction,ADR)。结果:共12例患者纳入此研究,4个周期治疗后疗效评估为完全缓解(complete response,CR)6例,部分缓解(partial response,PR)2例,疾病稳定(stable disease,SD)1例,疾病进展(progressive disease,PD)3例。ORR为66.7%,DCR为75%。中位无进展生存期(median progression free survival,mPFS)为7个月(95%CI:4.4~9.6个月),中位总生存期(median OS,mOS)为10.5个月(95%CI:6.1~14.9个月)。R-FPD化疗方案的主要不良反应为血液学毒性,Ⅲ~Ⅳ级粒细胞和血小板减少分别为16.7%和25.0%。c-myc蛋白高表达(>40%)可能与预后无关。结论:R-FPD对于初治的PCNSL患者是安全有效的方案。c-myc高表达与预后无显著相关性。Objectives:To evaluate the safety,efficacy,and feasibility of using rituximab in combination with fotemustine,pemetrexed,and dexamethasone(R-FPD)in primary central nervous system lymphoma(PCNSL).To undertake an initial exploration of the significance of biomarkers in PCNSL.Methods:This was a prospective,single-center,single-arm,phaseⅡclinical trial.Patients newly diagnosed with PCNSL from the First Affiliated Hospital of Zhengzhou University from July 2018 to July 2019 were enrolled.All patients underwent first-line chemotherapy with R-FPD.The primary study endpoints were:objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),and overall survival(OS).The secondary study endpoint was:adverse reactions(ADR).Results:Twelve patients were included in the study.After four cycles of treatment,six patients had complete remission,two had partial remission,one was stable,and three progressed.The ORR was 66.7%,DCR was 75%,and median PFS was 7 months(95%confidence interval:4.4-9.6 months).The median OS was 10.5 months(95%confidence interval:6.1-14.9 months).The main adverse reaction due to RFPD chemotherapy was hematologic toxicity,and gradeⅢ-Ⅳneutropenia and thrombocytopenia were observed(16.7%and 25%,respectively).High expression of c-myc protein(>40%)did not appear to be significantly associated with prognosis.Conclusions:R-FPD is an effective and safe protocol for the treatment of newly diagnosed PCNSL patients.There was no significant relationship between high c-myc expression and prognosis.

关 键 词：利妥昔单抗 原发中枢神经系统淋巴瘤 培美曲塞 福莫司汀 疗效 

分 类 号：R739.4[医药卫生—肿瘤]