A phase 1/2 trial of high-dose yttrium-90-ibritumomab tiuxetan in combination with high-dose etoposide and cyclophosphamide followed by autologous stem cell transplantation in patients with poor-risk or relapsed non-Hodgkin lymphoma
Author:
Nademanee Auayporn1, Forman Stephen1, Molina Arturo1, Fung Henry1, Smith David1, Dagis Andy1, Kwok Cheuk1, Yamauchi Dave1, Anderson Anne-Line1, Falk Peter1, Krishnan Amrita1, Kirschbaum Mark1, Kogut Neil1, Nakamura Ryotaro1, O'Donnell Margaret1, Parker Pablo1, Popplewell Leslie1, Pullarkat Vinod1, Rodriguez Roberto1, Sahebi Firoozeh1, Smith Eileen1, Snyder David1, Stein Anthony1, Spielberger Ricardo1, Zain Jasmine1, White Christine1, Raubitschek Andrew1
Affiliation:
1. From the Division of Hematology and Hematopoietic Cell Transplantation, Division of Information Services, Department of Radioimmunotherapy, and Division of Diagnostic Radiology, City of Hope National Medical Center, Duarte, CA; and Biogen Idec, Cambridge, MA/San Diego, CA.
Abstract
Abstract
We conducted a phase 1/2 trial of high-dose 90Y-ibritumomab tiuxetan in combination with high-dose etoposide (VP-16) 40 to 60 mg/kg (day -4) and cyclophosphamide 100 mg/kg (day -2) followed by autologous stem cell transplantation (ASCT) in 31 patients with CD20+ non-Hodgkin lymphoma (NHL). Patients underwent dosimetry (day -21) with 5 mCi (185 MBq) 111In-ibritumomab tiuxetan following 250 mg/m2 rituximab, followed a week later by 90Y-ibritumomab tiuxetan to deliver a target dose of 1000 cGy to highest normal organ. Bone marrow biopsy was done on day -7 to estimate radiation dose and stem cells were reinfused when the radiation dose was estimated to be less than 5 cGy. The median 90Y-ibritumomab tiuxetan dose was 71.6 mCi (2649.2 MBq; range, 36.6-105 mCi; range, 1354.2-3885 MBq). Histology included follicular lymphoma (n = 12), diffuse large B-cell (n = 14), and mantle cell (n = 5). The median number of prior chemo-therapy treatments was 2. The treatment was well tolerated. The median times to reach an absolute neutrophil count greater than 500/μL and platelet count more than 20 000/μL were 10 days and 12 days, respectively. There were 2 deaths and 5 relapses. At a median follow-up of 22 months, the 2-year estimated overall survival and relapse-free survival rates are 92% and 78%, respectively. We conclude that high-dose 90Y-ibritumomab tiuxetan can be combined safely with high-dose etoposide and cyclophosphamide without an increase in transplant-related toxicity or delayed engraftment. (Blood. 2005;106:2896-2902)
Publisher
American Society of Hematology
Subject
Cell Biology,Hematology,Immunology,Biochemistry
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