利妥昔单抗-环磷酰胺、长春新碱、阿霉素、泼尼松、依托泊苷方案，一种用于复发、难治或转化型B细胞淋巴瘤的有效挽救疗法：一项II期研究结果

Rituximab-EPOCH, an effective salvage therapy for relapsed, refractory or transformed B-cell lymphomas: results of a phase II study.

作者信息

Jermann M, Jost L M, Taverna Ch, Jacky E, Honegger H P, Betticher D C, Egli F, Kroner Th, Stahel R A

机构信息

University Hospital of Zurich, Switzerland.

出版信息

Ann Oncol. 2004 Mar;15(3):511-6. doi: 10.1093/annonc/mdh093.

DOI:10.1093/annonc/mdh093

PMID:14998858

Abstract

BACKGROUND

Relapsed or refractory diffuse large B-cell and mantle-cell lymphoma have a poor prognosis. The EPOCH regimen and rituximab monotherapy have demonstrated activity as salvage therapies. Because of their non-overlapping toxicity, we evaluated their combination as salvage therapy in a phase II study.

PATIENTS AND METHODS

Patients with relapsed or refractory CD20-positive large B-cell and mantle-cell lymphoma were offered treatment with rituximab 375 mg/m2 intravenously (i.v.) on day 1, doxorubicin 15 mg/m2 as a continuous i.v. infusion on days 2-4, etoposide 65 mg/m2 as a continuous i.v. infusion on days 2-4, vincristine 0.5 mg as a continuous i.v. infusion on days 2-4, cyclophosphamide 750 mg/m2 i.v. on day 5 and prednisone 60 mg/m2 orally on days 1-14.

RESULTS

Fifty patients, with a median age of 56 years (range 23-72), entered the study. Twenty-five had primary diffuse large B-cell lymphoma, 18 transformed large B-cell lymphoma and seven mantle-cell lymphoma. The median number of prior chemotherapy regimens was 1.7 (range one to four). The median number of treatment cycles was four (range one to six). Possible treatment-related death occurred in two patients. Objective responses were obtained in 68% of patients (28% complete responses, 40% partial responses). Nineteen patients received consolidating high-dose chemotherapy with autologous stem-cell transplantation. The median follow-up was 33 months. Three patients developed a secondary myelodysplastic syndrome. The median overall survival was 17.9 months; the projected overall survival at 1, 2 and 3 years was 66, 42 and 35%, respectively. The median event-free survival was 11.8 months; the projected event-free survival at 1, 2 and 3 years was 50, 30 and 26%, respectively.

CONCLUSION

The rituximab-EPOCH regimen is effective and well tolerated, even in extensively pretreated patients with relapsed or refractory large B-cell lymphoma and mantle-cell lymphoma.

摘要

背景

复发或难治性弥漫性大B细胞淋巴瘤和套细胞淋巴瘤预后较差。EPOCH方案和利妥昔单抗单药治疗已显示出作为挽救疗法的活性。由于它们的毒性不重叠，我们在一项II期研究中评估了它们联合作为挽救疗法的效果。

患者与方法

复发或难治性CD20阳性大B细胞淋巴瘤和套细胞淋巴瘤患者在第1天接受375mg/m²利妥昔单抗静脉注射，第2 - 4天阿霉素15mg/m²持续静脉输注，第2 - 4天依托泊苷65mg/m²持续静脉输注，第2 - 4天长春新碱0.5mg持续静脉输注，第5天环磷酰胺750mg/m²静脉注射，第1 - 14天泼尼松60mg/m²口服。

结果

50例患者进入研究，中位年龄56岁（范围23 - 72岁）。25例为原发性弥漫性大B细胞淋巴瘤，18例为转化型大B细胞淋巴瘤，7例为套细胞淋巴瘤。既往化疗方案的中位次数为1.7次（范围1至4次）。治疗周期的中位次数为4次（范围1至6次）。2例患者发生可能与治疗相关的死亡。68%的患者获得客观缓解（28%完全缓解，40%部分缓解）。19例患者接受了自体干细胞移植巩固性大剂量化疗。中位随访时间为33个月。3例患者发生继发性骨髓增生异常综合征。中位总生存期为17.9个月；1年、2年和3年的预计总生存率分别为66%、42%和35%。中位无事件生存期为11.8个月；1年、2年和3年的预计无事件生存率分别为50%、30%和26%。