Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results o the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study
Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results o the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study
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DOI：
10.1200/jco.18.00306
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发表时间：
2019-04-01
影响因子：
45.3
通讯作者：
Soussain, Carole
中科院分区：
文献类型：
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作者：
Houillier, Caroline;Taillandier, Luc;Soussain, Carole
目的确定化学免疫治疗后的全脑放疗（WBRT）或强化化疗和自体干细胞移植（ASCT）作为原发性CNS淋巴瘤（PCNSL）的一线治疗的疗效和毒性。（18至60岁）未经治疗的PCNSL患者在诱导化疗（包括两个周期的R-MBVP）后随机接受WBRT或ASCT作为巩固治疗（利妥昔单抗375 mg/m2，第1天（D），甲氨蝶呤3 g/m2（2）D1; D15，VP 16 100 mg/m2（2）D2，BCNU 100 mg/m2（2）D3，泼尼松60 mg/kg/d D1-D5），随后是两个周期的R-AraC（利妥昔单抗375 mg/m2（2）D1，阿糖胞苷3 g/m2（2）D1至D2）。强化化疗包括塞替派（250 mg/m2/d D9; D8; D 7）、白消安（8 mg/kg D 6至D4）和环磷酰胺（60 mg/kg/d D3; D2）。WBRT输送40戈伊（2戈伊/次）。主要终点是2年无进展生存期。认知结果是主要的次要终点。分析是在非比较II期trial.Results之间的意向治疗2008年10月和2014年2月，140例患者从23个法国中心招募。WBRT和ASCT均符合预定阈值（在每组的前38例患者中，至少24例患者在2年时存活且无疾病）。WBRT和ASCT组的2年无进展生存率分别为63%（95% CI，49%-81%）和87%（95% CI，77%-98%）。WBRT和ASCT后分别有1例和5例患者发生毒性死亡。WBRT后观察到认知功能障碍，而ASCT.CONCLUSION WBRT和ASCT后认知功能得到保留或改善PCNSL患者是有效的巩固治疗60岁及以下。疗效终点倾向于支持ASCT组，应考虑每种手术的具体风险。(C)2019年美国临床肿瘤学会
PURPOSE To determine the efficacy and toxicity of chemoimmunotherapy followed by either whole-brain radiotherapy (WBRT) or intensive chemotherapy and autologous stem-cell transplantation (ASCT) as a first-line treatment of primary CNS lymphoma (PCNSL).PATIENTS AND METHOL Immunocompetent patients (18 to 60 years of age) with untreated PCNSL were randomly assigned to receive WBRT or ASCT as consolidation treatment after induction chemotherapy consisting of two cycles of R-MBVP (rituximab 375 mg/m(2) day (D) 1, methotrexate 3 g/m(2) Dl; D15, VP16 100 mg/m(2) D2, BCNU 100 mg/m(2) D3, prednisone 60 mg/kg/d D1-D5) followed by two cycles of R-AraC (rituximab 375 mg/m(2) D1, cytarabine 3 g/m(2) D1 to D2). Intensive chemotherapy consisted of thiotepa (250 mg/m(2) /d D9; D8; D7), busulfan (8 mg/kg D6 through D4), and cyclophosphamide (60 mg/kg/d D3; D2). WBRT delivered 40 Gy (2 Gy/ fraction). The primary end point was 2-year progression-free survival. Cognitive outcome was the main secondary end point. Analysis was intention to treat in a noncomparative phase II trial.RESULTS Between October 2008 and February 2014, 140 patients were recruited from 23 French centers. Both WBRT and ASCT met the predetermined threshold (among the first 38 patients in each group, at least 24 patients were alive and disease free at 2 years). The 2-year progression-free survival rates were 63% (95% CI, 49% to 81%) and 87% (95% CI, 77% to 98%) in the WBRT and ASCT arms, respectively. Toxicity deaths were recorded in one and five patients after WBRT and ASCT, respectively. Cognitive impairment was observed after WBRT, whereas cognitive functions were preserved or improved after ASCT.CONCLUSION WBRT and ASCT are effective consolidation treatments for patients with PCNSL who are 60 years of age and younger. The efficacy end points tended to favor the ASCT arm. The specific risk of each procedure should be considered. (C) 2019 by American Society of Clinical Oncology