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Blood, 15 October 2005, Vol. 106, No. 8, pp. 2896-2902.
Prepublished online as a Blood First Edition Paper on July 7, 2005; DOI 10.1182/blood-2005-03-1310.
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TRANSPLANTATION
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
Auayporn Nademanee,
Stephen Forman,
Arturo Molina,
Henry Fung,
David Smith,
Andy Dagis,
Cheuk Kwok,
Dave Yamauchi,
Anne-Line Anderson,
Peter Falk,
Amrita Krishnan,
Mark Kirschbaum,
Neil Kogut,
Ryotaro Nakamura,
Margaret O'Donnell,
Pablo Parker,
Leslie Popplewell,
Vinod Pullarkat,
Roberto Rodriguez,
Firoozeh Sahebi,
Eileen Smith,
David Snyder,
Anthony Stein,
Ricardo Spielberger,
Jasmine Zain,
Christine White, and
Andrew Raubitschek
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.
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)
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