Adis, a Wolters Kluwer Business, Auckland, New Zealand.
BioDrugs. 2011 Feb 1;25(1):55-61. doi: 10.2165/11206980-000000000-00000.
Rituximab (MabThera®, Rituxan®) is a chimeric mouse anti-human CD20 monoclonal antibody. This article reviews the use of intravenous rituximab in the treatment of chronic lymphocytic leukemia (CLL), low-grade or follicular lymphoma, and diffuse large B-cell lymphoma. The addition of rituximab to fludarabine plus cyclophosphamide significantly prolonged progression-free survival both in previously untreated patients with CLL and in those with relapsed or refractory CLL, according to the results of two randomized, open-label, multicenter trials. In patients with previously untreated advanced follicular lymphoma, the addition of rituximab to chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP]; cyclophosphamide, vincristine, and prednisone [CVP]; mitoxantrone, chlorambucil, and prednisolone; or cyclophosphamide, doxorubicin, etoposide, and prednisolone) was generally associated with better outcomes than chemotherapy alone in randomized, multicenter trials. In a similarly designed trial, progression-free survival was significantly longer in previously untreated patients with follicular lymphoma, other indolent lymphomas, or mantle-cell lymphoma who received rituximab plus bendamustine than in those receiving rituximab plus CHOP. Monotherapy with rituximab also demonstrated efficacy in patients with relapsed or refractory low-grade or follicular lymphoma, according to the results of noncomparative trials. In terms of maintenance therapy, progression-free survival was significantly prolonged with rituximab maintenance therapy versus observation alone in patients with advanced indolent lymphoma who had not progressed following first-line therapy with CVP and in patients with relapsed or refractory follicular lymphoma who had responded to CHOP (with or without rituximab), according to the results of randomized, open-label, multicenter trials. In four randomized, open-label, multicenter trials in younger or elderly patients with previously untreated diffuse large B-cell lymphoma, event-free survival, failure-free survival, progression-free survival, and overall survival were generally improved to a significant extent by the addition of rituximab to CHOP or CHOP-like chemotherapy. Intravenous rituximab was generally well tolerated in patients with CLL, low-grade or follicular lymphoma, or diffuse large B-cell lymphoma, both as monotherapy and when administered in combination with chemotherapy. Infusion reactions were one of the most commonly occurring adverse events in patients receiving intravenous rituximab. The results of pharmacoeconomic modeling analyses demonstrated that rituximab appears to be cost effective in patients with previously untreated follicular lymphoma, in patients with follicular lymphoma receiving rituximab maintenance therapy following treatment for relapsed or refractory disease, and in patients with previously untreated diffuse large B-cell lymphoma. In conclusion, rituximab remains a valuable therapy in patients with CLL, low-grade or follicular lymphoma, and diffuse large B-cell lymphoma and, in a variety of treatment settings, represents the standard of care.
利妥昔单抗（美罗华®，罗氏）是一种嵌合鼠抗人 CD20 单克隆抗体。本文综述了静脉用利妥昔单抗治疗慢性淋巴细胞白血病（CLL）、低级别或滤泡性淋巴瘤以及弥漫性大 B 细胞淋巴瘤的应用。两项随机、开放标签、多中心试验的结果显示，在初治 CLL 患者和复发/难治性 CLL 患者中，利妥昔单抗联合氟达拉滨和环磷酰胺可显著延长无进展生存期。在初治晚期滤泡性淋巴瘤患者中，与单独化疗（环磷酰胺、多柔比星、长春新碱和泼尼松[CHOP]；环磷酰胺、长春新碱和泼尼松[CVP]；米托蒽醌、苯丁酸氮芥和泼尼松；或环磷酰胺、多柔比星、依托泊苷和泼尼松）相比，利妥昔单抗联合化疗通常在随机、多中心试验中提供更好的结局。在一项设计相似的试验中，初治滤泡性淋巴瘤、其他惰性淋巴瘤或套细胞淋巴瘤患者接受利妥昔单抗联合苯达莫司汀治疗的无进展生存期显著长于接受利妥昔单抗联合 CHOP 治疗的患者。非比较试验表明，利妥昔单抗单药治疗在复发/难治性低级别或滤泡性淋巴瘤患者中也具有疗效。在维持治疗方面，与单独观察相比，在未进展的初治 CVP 后进展期惰性淋巴瘤患者和对 CHOP（有或无利妥昔单抗）有反应的复发/难治性滤泡性淋巴瘤患者中，利妥昔单抗维持治疗可显著延长无进展生存期，根据随机、开放标签、多中心试验的结果。在四项年轻或老年初治弥漫性大 B 细胞淋巴瘤患者的随机、开放标签、多中心试验中，利妥昔单抗联合 CHOP 或 CHOP 样化疗通常可显著提高无事件生存率、无失败生存率、无进展生存率和总生存率。静脉用利妥昔单抗在 CLL、低级别或滤泡性淋巴瘤或弥漫性大 B 细胞淋巴瘤患者中，无论是单药治疗还是联合化疗，通常都具有良好的耐受性。输注反应是接受静脉用利妥昔单抗治疗的患者最常发生的不良事件之一。药物经济学模型分析的结果表明，利妥昔单抗在初治滤泡性淋巴瘤患者、复发/难治性疾病接受利妥昔单抗维持治疗的滤泡性淋巴瘤患者以及初治弥漫性大 B 细胞淋巴瘤患者中具有成本效益。总之，利妥昔单抗仍然是 CLL、低级别或滤泡性淋巴瘤和弥漫性大 B 细胞淋巴瘤患者的一种有价值的治疗方法，在各种治疗环境下，它代表了治疗标准。
