Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia.

Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia.
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DOI:
10.1038/leu.2009.133
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发表时间:
2009-10
期刊:
影响因子:
11.4
通讯作者:
--
中科院分区:
医学1区
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--
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我们观察到,大剂量甲基强的松龙(HSP 70)和利妥昔单抗(R)联合治疗氟达拉滨难治性慢性淋巴细胞白血病(CLL)患者耐受性良好,并具有良好的活性。这促使我们评估这些药物在一线治疗中的使用。28例患者入组本研究,中位年龄为65岁。患者在三个四周周期中的每个周期中接受每天1 g/m2的Hastin,持续三天,同时接受利妥昔单抗和预防性抗微生物治疗。治疗耐受性良好,很少有III级或更高级别的不良事件。总有效率为96%(N=27)。9例患者(32%)达到完全缓解(CR),其中2例未检出微小残留病(MRD)。6例MRD患者接受了Alemtuzumab巩固治疗;其中5例患者达到了MRD阴性CR。随访3年以上,中位无进展生存期为30.3个月,仅39%的患者需要额外治疗,总生存率为96%。这项研究表明,HALLY和利妥昔单抗是一种有效的非骨髓抑制治疗组合,用于CLL患者,值得考虑,特别是对于可能无法耐受标准治疗方案的骨髓储备有限的患者。
We observed that high-dose methylprednisolone (HDMP) and rituximab (R) was well tolerated and had promising activity when used in combination to treat patients with fludarabine-refractory chronic lymphocytic leukemia (CLL). This prompted us to evaluate the use of these agents in frontline therapy. Twenty-eight patients with a median age of 65 enrolled in this study. Patients received HDMP at 1 g/m2 each day for three days during each of the three four-week cycles together with rituximab and prophylactic anti-microbial therapy. The treatment was well tolerated with few adverse events of grade III or higher. The overall response rate was 96% (N=27). Nine patients (32%) achieved a complete remission (CR), two of which were without detectable minimal residual disease (MRD). Six patients with MRD received consolidation with alemtuzumab; five of these patients achieved an MRD-negative CR. With over three years of follow-up median progression free survival was 30.3 months with only 39% of patients requiring additional therapy, and an overall survival was 96%. This study demonstrates that HDMP and rituximab is an effective non-myelosuppressive treatment combination for patients with CLL that warrants consideration particularly for patients with limited myeloid reserve that might not tolerate standard treatment regimens.
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