• John P Leonard, Morton Coleman, Jamie C Ketas, Amy Chadburn, Richard Furman, Michael W Schuster, Eric J Feldman, Michelle Ashe, Stephen J Schuster, William A Wegener, Hans J Hansen, Heather Ziccardi, Michael Eschenberg, Urte Gayko, Scott Z Fields, Alessandra Cesano, and David M Goldenberg.
• Division of Hematology and Oncology, Center for Lymphoma and Myeloma, Weill Medical College of Cornell University and New York Presbyterian Hospital, New York, New York 10021, USA. jpleonar@med.cornell.edu
• Clin Cancer Res. 2004 Aug 15; 10 (16): 5327-34.

PurposeWe conducted a single-center, dose-escalation study evaluating the safety, pharmacokinetics, and efficacy of epratuzumab, an anti-CD22 humanized monoclonal antibody, in patients with aggressive non-Hodgkin's lymphoma.Experimental DesignEpratuzumab was administered once weekly for 4 weeks at 120-1000-mg/m2 doses to 56 patients [most (n = 35) with diffuse large B-cell lymphoma].ResultsPatients were heavily pretreated (median, 4 prior therapies), 25% received prior high-dose chemotherapy with stem cell transplant, and 84% had bulky disease (> or =5 cm). Epratuzumab was well tolerated, with no dose-limiting toxicity. Most (95%) infusions were completed within 1 h. The mean serum half-life was 23.9 days. Across all dose levels and histologies, objective responses (ORs) were observed in five patients (10%; 95% confidence interval, 3-21%), including three complete responses. In patients with diffuse large B-cell lymphoma, 15% had ORs. Overall, 11 (20%) patients experienced some tumor mass reduction. Median duration of OR was 26.3 weeks, and median time to progression for responders was 35 weeks. Two responses are ongoing at > or =34 months, including one rituximab-refractory patient.ConclusionsThese data demonstrate that epratuzumab has a good safety profile and exerts antitumor activity in aggressive non-Hodgkin's lymphoma at doses of > or =240 mg/m2, thus warranting further evaluation in this clinical setting.

44 keywords...

hide…