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Abstract：
Studies on the efficacy of rituximab in primary CNS lymphoma (PCNSL) reported conflicting results. Our international randomized phase 3 study showed that the addition of rituximab to high-dose methotrexate, BCNU, teniposide, and prednisolone (MBVP) in PCNSL was not efficacious in the short term. Here we present long-term results after a median follow-up of 82.3 months.
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.
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.
摘要：
背景：关于利妥昔单抗治疗原发性中枢神经系统淋巴瘤（PCNSL）疗效的研究报告了相互矛盾的结果。我们的国际随机III期研究表明，在高剂量甲氨蝶呤中加入利妥昔单抗，BCNU,替尼泊苷和泼尼松龙（MBVP）在PCNSL中的短期疗效不佳。在这里，我们提供了中位随访82.3个月后的长期结果。
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。
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。
