Originally published as JCO Early Release 10.1200/JCO.2007.11.9248 on November 19 2007

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Phase II Trial of a Transplantation Regimen of Yttrium-90 Ibritumomab Tiuxetan and High-Dose Chemotherapy in Patients With Non-Hodgkin's Lymphoma

Amrita Krishnan, Auayporn Nademanee, Henry C. Fung, Andrew A. Raubitschek, Arturo Molina, Dave Yamauchi, Roberto Rodriguez, Ricardo T. Spielberger, Peter Falk, Joycelynne M. Palmer, Stephen J. Forman

From the Division of Hematology and Hematopoietic Cell Transplantation, City of Hope Comprehensive Cancer Center, Duarte; Oncology Research and Development, Biogen Idec, San Diego, CA; and Section of Hematology and Stem Cell Transplantation, Rush University Medical Center, Chicago, IL

Corresponding author: Amrita Krishnan, MD, Division of Hematology and Hematopoietic Cell Transplantation, City of Hope Comprehensive Cancer Center, 1500 East Duarte Rd, Duarte, CA 91010; e-mail: akrishnan{at}coh.org

Purpose This phase II trial evaluated the safety and efficacy of combining yttrium-90 (⁹⁰Y) ibritumomab tiuxetan with high-dose carmustine, cytarabine, etoposide, and melphalan (BEAM) and autologous stem-cell transplantation in patients with non-Hodgkin's lymphoma who were considered ineligible for total-body irradiation because of older age or prior radiotherapy.

Patients and Methods Between May 2002 and January 2006, 14 days before autologous stem-cell transplantation, 41 patients with non-Hodgkin's lymphoma received standard-dose ⁹⁰Y ibritumomab tiuxetan (14.8 MBq/kg [0.4 mCi/kg]) followed by high-dose BEAM.

Results The median age was 60 years (range, 19 to 78 years), and the median number of previous therapies was two (range, one to six). Disease histologies were diffuse large B-cell (n = 20), mantle cell (n = 13), follicular (n = 4), and transformed lymphoma (n = 4). With a median follow-up of 18.4 months (range, 5.5 to 53.3 months) the estimated 2-year overall and progression-free survival were 88.9% (95% CI, 75.3% to 95.2%) and 69.8% (95% CI, 56.4% to 79.7%). The median time to WBC engraftment was 11 days (range, 9 to 26 days) and time to platelet engraftment was 12 days (range, 3 to 107 days). Adverse events were similar to those seen historically with high-dose BEAM alone, and included grade 3 or 4 pulmonary toxicity in 10 patients.

Conclusion Adding ⁹⁰Y ibritumomab tiuxetan to high-dose BEAM with autologous stem-cell transplantation is feasible and has a toxicity and tolerability profile similar to that observed with BEAM alone. Rates of progression-free survival seen in these patients are promising and warrant additional study.

published online ahead of print at www.jco.org on November 19, 2007.

Supported by Grant No. M01 RR0043 of the General Clinical Research Center, Cancer Center Support Grant No. P30CA3357, and Hematopoietic Cell Transplantation for Hematologic Malignancies Grant No. P01 CA030206.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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