One hundred and ninety-nine eligible newly diagnosed, nonimmunocompromised patients with PCNSL aged 18-70 years with WHO performance status 0-3 was randomized between treatment with MBVP chemotherapy with or without rituximab, followed by high-dose cytarabine consolidation in responding patients, and reduced-dose WBRT in patients aged ≤ 60 years. Event-free survival was the primary endpoint. Overall survival rate, neurocognitive functioning (NCF), and health-related quality of life (HRQoL) were additionally assessed, with the IPCG test battery, EORTC QLQ-C30 and QLQ-BN20 questionnaires, respectively.
For event-free survival, the hazard ratio was 0.85, 95% CI 0.61-1.18, P = .33. Overall survival rate at 5 years for MBVP and R-MBVP was 49% (39-59) and 53% (43-63) respectively. In total, 64 patients died in the MBVP arm and 55 in the R-MBVP arm, of which 69% were due to PCNSL. At the group level, all domains of NCF and HRQoL improved to a clinically relevant extent after treatment initiation, and remained stable thereafter up to 60 months of follow-up, except for motor speed which deteriorated between 24 and 60 months. Although fatigue improved initially, high levels persisted in the long term.
Long-term follow-up confirms the lack of added value of rituximab in addition to MBVP and HD-cytarabine for PCNSL.
方法:199名符合条件的新诊断,年龄18-70岁,WHO表现状态0-3的非免疫功能低下的PCNSL患者被随机分为MBVP化疗联合或不联合利妥昔单抗治疗,其次是高剂量阿糖胞苷巩固反应患者,年龄≤60岁患者的WBRT剂量减少。无事件生存期是主要终点。总生存率,神经认知功能(NCF),并对健康相关生活质量(HRQoL)进行了额外评估,使用IPCG测试电池,EORTCQLQ-C30和QLQ-BN20问卷,分别。
结果:对于无事件生存,风险比为0.85,95%置信区间0.61-1.18,p=0.33.MBVP和R-MBVP的5年总生存率分别为49%(39-59)和53%(43-63)。总的来说,MBVP组64例死亡,R-MBVP组55例死亡,其中69%归因于PCNSL。在团体层面,治疗开始后,NCF和HRQoL的所有领域均改善至临床相关程度,此后保持稳定长达60个月的随访,除了电机速度在24到60个月之间恶化。虽然疲劳最初有所改善,高水平长期持续存在。
结论:长期随访证实,除了MBVP和HD-阿糖胞苷用于PCNSL外,利妥昔单抗缺乏附加值。