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一项关于阿仑单抗、氟达拉滨、环磷酰胺和多柔比星(Campath-FCD)在周围 T 细胞淋巴瘤中的 II 期研究。

A phase II study of alemtuzumab, fludarabine, cyclophosphamide, and doxorubicin (Campath-FCD) in peripheral T-cell lymphomas.

机构信息

Klinik für Onkologie und Hämatologie, Krankenhaus Nordwest, Frankfurt am Main, Germany.

出版信息

Leuk Lymphoma. 2010 Mar;51(3):447-55. doi: 10.3109/10428190903580402.

DOI:10.3109/10428190903580402
PMID:20141439
Abstract

The clinical course of peripheral T-cell lymphoma (PTCL) is usually aggressive and the prognosis unfavorable. Therefore, there is a need for improvement of treatment options. Patients with newly diagnosed (n = 27) or refractory/relapsed (n = 11) PTCL received a combination of alemtuzumab, fludarabine, cyclophosphamide, and doxorubicin. The overall response rate (ORR) was 61%, with a complete response rate of 39%. In newly diagnosed patients the ORR was 63%, the median overall survival 25.9 months, and progression-free survival 11.8 months. In relapsed/refractory patients the median OS was 6.1 months. The most frequent grade 3/4 toxicities were leukopenia (95% of patients) and thrombocytopenia (58%). Cytomegalovirus (CMV) reactivation occurred in 12 patients, but only two had CMV disease. Treatment-related deaths occurred in six newly diagnosed patients and one with relapsed/refractory disease. In conclusion, Campath-FCD is active in PTCL but is associated with significant toxicity and is, therefore, not recommended for use or further study. Further studies are warranted to investigate other approaches to combining alemtuzumab with chemotherapy for the treatment of PTCL.

摘要

外周 T 细胞淋巴瘤(PTCL)的临床病程通常具有侵袭性,预后不佳。因此,需要改进治疗方案。27 例初诊(n = 27)和 11 例难治/复发(n = 11)PTCL 患者接受了阿仑单抗、氟达拉滨、环磷酰胺和多柔比星的联合治疗。总体缓解率(ORR)为 61%,完全缓解率为 39%。在初诊患者中,ORR 为 63%,总生存期中位数为 25.9 个月,无进展生存期中位数为 11.8 个月。在复发/难治患者中,中位总生存期为 6.1 个月。最常见的 3/4 级毒性为白细胞减少(95%的患者)和血小板减少(58%)。12 例患者发生巨细胞病毒(CMV)再激活,但仅有 2 例发生 CMV 疾病。6 例初诊患者和 1 例复发/难治患者发生治疗相关死亡。总之,Campath-FCD 在 PTCL 中具有活性,但与显著的毒性相关,因此不推荐使用或进一步研究。需要进一步研究以探讨其他方法将阿仑单抗与化疗联合用于治疗 PTCL。

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