文章：

奥法木单抗联合大剂量甲基强的松龙治疗复发或难治性慢性淋巴细胞白血病患者

Ofatumumab and high-dose methylprednisolone for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia

原文发布日期：2014-11-14

DOI: 10.1038/bcj.2014.76

类型: Original Article

开放获取: 是

英文摘要：

Ofatumumab is a humanized anti-CD20 monoclonal antibody that has been approved by the FDA for the treatment of patients with chronic lymphocytic leukemia. We conducted a phase II single-arm study at a single center. Patients received ofatumumab (300 mg then 1000 mg weekly for 12 weeks) and methylprednisolone (1000 mg/m2 for 3 days of each 28-day cycle). Twenty-one patients enrolled, including 29% with unfavorable cytogenetics (del17p or del11q). Ninety percent of patients received the full course without dose reductions or delays. The overall response rate was 81% (17/21) with 5% complete response, 10% nodular partial response, 67% partial response, 14% stable disease and 5% progressive disease. After a median follow-up of 31 months, the median progression-free survival was 9.9 months and the median time to next treatment was 12.1 months. The median overall survival has not yet been reached. The combination of high-dose methylprednisolone and ofatumumab is an effective and tolerable treatment regimen. This regimen may be useful for patients who are unable to tolerate more aggressive therapies, or have not responded to other treatments.

摘要翻译： 

奥法木单抗是一种人源化抗CD20单克隆抗体，已获美国食品药品监督管理局批准用于治疗慢性淋巴细胞白血病患者。我们在单一中心开展了一项II期单臂研究。患者接受奥法木单抗（300毫克，随后1000毫克每周一次，持续12周）和甲泼尼龙（每个28天周期中连续3天每日1000毫克/平方米）治疗。共入组21例患者，其中29%伴有不良细胞遗传学特征（del17p或del11q）。90%的患者完成了全程治疗且无需剂量调整或延迟给药。总缓解率为81%（17/21），其中完全缓解率5%，结节性部分缓解率10%，部分缓解率67%，疾病稳定率14%，疾病进展率5%。中位随访31个月后，中位无进展生存期为9.9个月，中位至下次治疗时间为12.1个月。中位总生存期尚未达到。大剂量甲泼尼龙联合奥法木单抗是一种有效且耐受性良好的治疗方案。该方案可能适用于无法耐受更强效治疗或对其他治疗无应答的患者。

原文链接：

Ofatumumab and high-dose methylprednisolone for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia