期刊
BRITISH JOURNAL OF HAEMATOLOGY
卷 136, 期 3, 页码 439-447出版社
WILEY
DOI: 10.1111/j.1365-2141.2006.06457.x
关键词
ontak; denileukin diftitox; non-Hodgkin lymphoma; T-cell non-Hodgkin lymphoma; relapsed/refractory T-cell non-Hodgkin lymphoma
类别
This phase II study evaluated the safety and efficacy of denileukin diftitox, an interleukin-2-diphtheria toxin fusion protein, in relapsed/refractory T-cell non-Hodgkin lymphoma (T-NHL), excluding cutaneous T-cell lymphoma. Eligible patients received denileukin diftitox 18 mu g/kg/d x 5 d every 3 weeks for up to eight cycles. Tumour staging was performed every two cycles and the primary endpoint was the objective response rate [complete response (CR) + partial response (PR)]. For 27 patients enrolled, median age: 55 years (range 26-80 years), 70-4% male, and mean prior therapies: 2(.)5 (range 1-6). Objective responses (six CRs, seven PRs) were achieved in 13 patients (48(.)1%), stable disease in eight (29(.)6%) and six (22(.)2%) had progressive disease. An objective response was achieved in eight of 13 patients (61(.)5%) with CD25(+) tumours (four CR/four PR) and five of 11 patients (45(.)5%) with CD25(-) tumours (two CR/three PR). Median progression-free survival was 6 months (range, 1-38+ months). Most adverse reactions were grade 1/2 and transient. No grade 4-5 toxicities were reported. Denileukin diftitox had significant activity and was well tolerated in relapsed/refractory T-NHL, with responses observed in both CD25(+) and CD25(-) tumours. Further studies of denileukin diftitox in combination with other agents are warranted in previously untreated and relapsed/refractory T-NHL.
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