Division of Hematology-Oncology, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC 20007, USA.
Clin Lymphoma Myeloma Leuk. 2010 Feb;10(1):21-7. doi: 10.3816/CLML.2010.n.002.
Bendamustine is a novel bifunctional alkylating agent with promising activity in lymphoid malignancies and several solid tumors. Unfortunately, the early development of this agent did not provide sufficient information on which to determine an optimal systematic dose and schedule. As a result, administration of the agent has been inconsistent among studies. The use of this drug has been increasing since it has been approved by the US Food and Drug Administration for chronic lymphocytic leukemia and rituximab-refractory indolent B-cell non-Hodgkin lymphoma, and is expected to increase further following anticipated European regulatory approval. Thus, a consensus meeting was convened to develop recommendations for standardizing the administration of the drug based on the available clinical data. Recommendations were developed including dose and schedule for the various clinical indications, as a single agent and in combination therapy, and to provide guidance for supportive measures. This report, representing the conclusions of that meeting, should provide guidance for the clinician until definitive dose-finding studies have been conducted.
苯达莫司汀是一种新型的双功能烷化剂,在淋巴恶性肿瘤和几种实体肿瘤中有很好的疗效。遗憾的是,该药物在早期开发过程中并没有提供足够的信息来确定最佳的系统剂量和方案。因此,在研究中该药物的使用并不统一。自苯达莫司汀被美国食品药品监督管理局批准用于慢性淋巴细胞白血病和利妥昔单抗难治性惰性 B 细胞非霍奇金淋巴瘤以来,其使用量一直在增加,预计在预期的欧洲监管批准后还会进一步增加。因此,召开了一次共识会议,根据现有临床数据制定了标准化管理该药物的建议。制定的建议包括各种临床适应证的剂量和方案,单药和联合治疗,并为支持措施提供指导。本报告代表了会议的结论,在进行明确的剂量发现研究之前,应指导临床医生。