Itälä M, Geisler C H, Kimby E, Juvonen E, Tjonnfjord G, Karlsson K, Remes K
Haematological Departments of Turku University Hospital, Finland; Rigshospitalet, Copenhagen, Denmark.
Eur J Haematol. 2002 Sep;69(3):129-34. doi: 10.1034/j.1600-0609.2002.02786.x.
This prospective multicentre study was conducted to assess the efficacy of the monoclonal anti-CD20 antibody rituximab in patients with chronic lymphocytic leukaemia (CLL). Secondary objectives were defined as the tolerability and feasibility of rituximab in patients with CLL.
Twenty-four heavily pretreated patients with CLL were treated with a standard dose of 375 mg m-2 of rituximab given once weekly for four doses.
The overall response rate was 35% and all the responses were partial as defined by the revised NCI criteria. In 17 (85%) of 20 patients with initially measurable peripheral lymph nodes the size of lymph nodes decreased by at least 50%, while an improvement of the bone marrow infiltration was observed only in two (11%) of 18 evaluable patients. The median duration of the overall response was 12.5 wk. Rituximab was relatively well tolerated. Although side-effects were common (75%) they were usually mild or moderate. There was only one grade 3 adverse event and no grade 4 events.
Standard-dose rituximab has activity in heavily pretreated patients with CLL, although the response is mainly limited to the lymph nodes and of short duration. Since rituximab has in vitro synergism with chemotherapeutic agents and is well tolerated by CLL patients, it is reasonable to investigate rituximab in combination with other treatments.
开展这项前瞻性多中心研究以评估单克隆抗CD20抗体利妥昔单抗对慢性淋巴细胞白血病（CLL）患者的疗效。次要目标定义为利妥昔单抗在CLL患者中的耐受性和可行性。
24例接受过大量预处理的CLL患者接受标准剂量375mg/m²的利妥昔单抗治疗，每周给药1次，共4剂。
总缓解率为35%，根据修订的美国国立癌症研究所（NCI）标准，所有缓解均为部分缓解。在20例最初可测量外周淋巴结的患者中，17例（85%）淋巴结大小至少减小50%，而在18例可评估患者中，仅2例（11%）观察到骨髓浸润有所改善。总缓解的中位持续时间为12.5周。利妥昔单抗的耐受性相对良好。虽然副作用常见（75%），但通常为轻度或中度。仅出现1例3级不良事件，无4级事件。
标准剂量的利妥昔单抗对接受过大量预处理的CLL患者有活性，尽管缓解主要局限于淋巴结且持续时间较短。由于利妥昔单抗在体外与化疗药物具有协同作用，且CLL患者对其耐受性良好，因此研究利妥昔单抗与其他治疗方法联合使用是合理的。
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