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

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(...

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

  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, phase Ⅱ clinical 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 grade Ⅲ-Ⅳ neutropenia 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.