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Clinical Trial
. 2005 Oct 15;106(8):2896-902.
doi: 10.1182/blood-2005-03-1310. Epub 2005 Jul 7.

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  1 , 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, Andrew Raubitschek
Affiliations
Clinical Trial

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 et al. Blood. .

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/microL and platelet count more than 20,000/microL 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.

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Figures

Figure 1.
Figure 1.
Treatment plan. NM indicates nuclear medicine; BM Bx, bone marrow biopsy; VP-16, etoposide; CTX, cyclophosphamide.
Figure 2.
Figure 2.
Response in patient with refractory relapsed DLBCL.
Figure 3.
Figure 3.
Kaplan-Meier estimated 2-year DFS and OS of 31 patients who underwent high-dose 90Y-ibritumomab tiuxetan and ASCT in NHL.
Figure 4.
Figure 4.
OS of 31 patients who underwent high-dose 90Y-ibritumomab tiuxetan and ASCT in NHL, based on histology.
Figure 5.
Figure 5.
DFS of 31 patients who underwent high-dose 90Y-ibritumomab tiuxetan and ASCT in NHL, based on histology.
See this image and copyright information in PMC

References

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