A Phase II Trial of Denileukin Diftitox in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

• DOI: 10.1097/coc.0b013e318187dd40
• Publication Date: 2009-05-21T09:48:55Z
• Authors: Margie Gerena-Lewis; Jeffrey Crawford; Philip Bonomi; Ann Marie Maddox; John Hainsworth; David E. McCune; Rakesh Shukla; Haoyue Zeigler; Paul Hurtubise; Tracy R. Chowdhury; Brandon Fletcher; Karyn Dyehouse; Richard Ghalie; Abdul R. Jazieh
• Keywords: Regimen; Diphtheria Toxin; Chemotherapy regimen

Denileukin diftitox, a chimeric protein, uses the cytocidal properties of diphtheria toxin to cells expressing interleukin-2 receptors. The aim this study was evaluate efficacy and safety denileukin diftitox in treatment advanced relapsed nonsmall cell lung cancer (NSCLC).Multicenter phase II trial patients with NSCLC Eastern Cooperative Oncology Group PS 0-2, stage IIIB/IV at diagnosis, who had failed least 1 previous chemotherapy regimen. infused 18 microg/kg/d x 5 days, every 21 days for 6 cycles.For 41 enrolled, median age 56 years (range, 21-80), 25 were men, number regimens 2 1-5). cycles 1-6). By RECIST criteria, (44%) stable disease, 10 (24%) progressive 13 (32%) not evaluable response as they received less than cycles. time disease progression 1.8 months [range, 0.3-11.3; 95% confidence interval (CI) 1.3-2.6]. Median survival 5.8 0.3-33.6; CI 3.4-11.4). follow-up 16.1 month. One death from myocarditis verified autopsy attributed treatment. grade 4 toxicity (vascular leak syndrome) encountered, 3 toxicities, primarily gastro-intestinal, vascular syndrome, constitutional symptoms.Denileukin current dose schedule has limited activity previously treated NSCLC, manifested by control without impact on survival.