Allen S L, Schacter L P, Lichtman S M, Bukowski R, Fusco D, Hensley M, O'Dwyer P, Mittelman A, Rosenbloom B, Huybensz S
North Shore University Hospital, Cornell University Medical College, Manhasset, NY, USA.
Invest New Drugs. 1996;14(2):213-7. doi: 10.1007/BF00210793.
To determine the response rate of patients with refractory/relapsed non-Hodgkin's lymphoma to treatment with elsamitrucin and to further characterize the toxic effects of elsamitrucin in this group of patients.
Eligibility required pathologically verified relapsed or refractory non-Hodgkin's lymphoma with no more than two prior chemotherapy regimens for patients with tumors classified by the International Working Formulation (IWF) as A-C and no more than one prior chemotherapy for those with IWF grades D-G. Patients were entered with either normal or impaired bone marrow function, but normal liver function tests were required unless clearly related to lymphomatous involvement of the liver. Elsamitrucin 25 mg/m2 was administered intravenously over 5-10 minutes weekly.
Thirty-one patients entered the study and were treated for a median of six weeks (range 1-42). All patients were evaluable for toxicity and 30 for response. Mild nausea and/or vomiting and asthenia were the most frequently reported adverse events. Four (13%, 95% Cl 4.4-31.6%) partial responses were seen along with two (7%) minor responses while 9 (30%) patients had stable disease.
Elsamitrucin showed modest activity in patients with relapsed or refractory non-Hodgkin's lymphoma. Toxicity was relatively mild, consisted mainly of asthenia, nausea and vomiting and did not include myelosuppression. The activity of elsamitrucin in this group of patients and its lack of myelosuppression suggest utility in this disease especially when combined with other proven agents.
确定难治性/复发性非霍奇金淋巴瘤患者接受埃沙米曲星治疗的缓解率，并进一步明确埃沙米曲星在该组患者中的毒性作用特征。
入选标准要求经病理证实为复发性或难治性非霍奇金淋巴瘤，按照国际工作分类法（IWF）分类为A - C级肿瘤的患者既往化疗方案不超过两种，IWF分级为D - G级的患者既往化疗不超过一种。患者骨髓功能正常或受损均可入组，但肝功能检查需正常，除非与肝脏淋巴瘤浸润明确相关。埃沙米曲星25 mg/m²每周静脉滴注5 - 10分钟。
31例患者进入研究，中位治疗时间为6周（范围1 - 42周）。所有患者均可评估毒性，30例可评估疗效。最常报告的不良事件为轻度恶心和/或呕吐以及乏力。观察到4例（13%，95%CI 4.4 - 31.6%）部分缓解，2例（7%）轻微缓解，9例（30%）患者病情稳定。
埃沙米曲星在复发性或难治性非霍奇金淋巴瘤患者中显示出一定活性。毒性相对较轻，主要包括乏力、恶心和呕吐，不包括骨髓抑制。埃沙米曲星在该组患者中的活性及其缺乏骨髓抑制表明其在该疾病中具有应用价值，尤其是与其他已证实的药物联合使用时。
