Department of Hematology.
Biostatistics Unit, Centre Léon Bérard, Université de Lyon, Lyon.
Ann Oncol. 2010 Apr;21(4):842-850. doi: 10.1093/annonc/mdp529. Epub 2009 Nov 13.
This prospective multicentric phase II study aimed to confirm the results of the C5R protocol of high-dose methotrexate (MTX)-based chemotherapy (CT) for immunocompetent primary central nervous system lymphoma.
A total of 99 patients received age-adapted CT (C5R protocol) followed by radiotherapy. Patients younger than 61 years (group 1, n = 45) received the full C5R with MTX, doxorubicin, vincristine, cyclophosphamide, and cytarabine. Patients aged 61-70 years (group 2, n = 36) received reduced doses. Patients older than 70 years (group 3, n = 18) received four courses of MTX, cyclophosphamide, and etoposide.
Median age was 63 years and 51% of patients had performance status of more than one. Seventeen patients died of toxicity during CT. Complete response was achieved in 56%, 53%, and 28% of patients in groups 1, 2, and 3, respectively. With a median follow-up of 83 months, the 5-year progression-free survival was 31%, 28%, and 11% and the 5-year overall survival 42%, 31%, and 17% for groups 1, 2, and 3, respectively. Leukoencephalopathy occurred in 32% of assessable patients, in both group 1 and groups 2-3.
The C5R protocol was feasible in the multicentric setting with favorable long-term survival in patients younger than 60 years. Despite dose adaptation, results in older patients were disappointing.
本前瞻性多中心 II 期研究旨在确认 C5R 方案高剂量甲氨蝶呤(MTX)为基础的化疗(CT)在免疫功能正常的原发性中枢神经系统淋巴瘤中的疗效。
共 99 例患者接受年龄调整的 CT(C5R 方案)后行放疗。年龄<61 岁的患者(组 1,n=45)接受包含 MTX、阿霉素、长春新碱、环磷酰胺和阿糖胞苷的完整 C5R 方案。61-70 岁的患者(组 2,n=36)接受剂量减少的方案。年龄>70 岁的患者(组 3,n=18)接受 4 个疗程的 MTX、环磷酰胺和依托泊苷。
中位年龄为 63 岁,51%的患者 PS>1。17 例患者在 CT 期间因毒性而死亡。组 1、2 和 3 患者的完全缓解率分别为 56%、53%和 28%。中位随访 83 个月,组 1、2 和 3 的 5 年无进展生存率分别为 31%、28%和 11%,5 年总生存率分别为 42%、31%和 17%。可评估患者中有 32%发生了脑白质病,组 1 和组 2-3 均有发生。
C5R 方案在多中心环境中是可行的,<60 岁患者的长期生存良好。尽管进行了剂量调整,但老年患者的结果仍令人失望。