Originally published as JCO Early Release 10.1200/JCO.2006.09.1215 on February 20 2007

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High-Dose [¹³¹I]Tositumomab (anti-CD20) Radioimmunotherapy and Autologous Hematopoietic Stem-Cell Transplantation for Adults 60 Years Old With Relapsed or Refractory B-Cell Lymphoma

Ajay K. Gopal, Joseph G. Rajendran, Ted A. Gooley, John M. Pagel, Darrell R. Fisher, Stephen H. Petersdorf, David G. Maloney, Janet F. Eary, Frederick R. Appelbaum, Oliver W. Press

From the Department of Medicine, Division of Medical Oncology; the Department of Radiology, Division of Nuclear Medicine, University of Washington; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; and the Pacific Northwest National Laboratory, Richland, WA

Address reprint requests to Ajay K. Gopal, MD, University of Washington/Seattle Cancer Care Alliance, 825 Eastlake Ave E G6-800, Seattle, WA 98195; e-mail: agopal{at}u.washington.edu

Purpose: The majority of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) are older than 60 years, yet they are often denied potentially curative high-dose therapy and autologous stem-cell transplantations (ASCT) because of the risk of excessive treatment-related morbidity and mortality. Myeloablative anti-CD20 radioimmunotherapy (RIT) can deliver curative radiation doses to tumor sites while limiting exposure to normal organs and may be particularly suited for older adults requiring high-dose therapy.

Patients and Methods: Patients older than 60 years with relapsed B-cell NHL (B-NHL) received infusions of tositumomab anti-CD20 antibody labeled with 185 to 370 Mbq (5 to 10 mCi) [¹³¹I]-tracer for dosimetry purposes followed 10 days later by individualized therapeutic infusions of [¹³¹I]tositumomab (median, 19.4 Gbq [525 mCi]; range, 12.1 to 42.7 Gbq [328 to 1,154 mCi]) to deliver 25 to 27 Gy to the critical normal organ receiving the highest radiation dose. ASCT was performed approximately 2 weeks after therapy.

Results: Twenty-four patients with a median age of 64 years (range, 60 to 76 years), who had received a median of four prior regimens (range, two to 14 regimens), were treated. Thirteen patients (54%) had chemotherapy-resistant disease. The estimated 3-year overall and progression-free survival rates were 59% and 51%, respectively, with a median follow-up of 2.9 years (range, 1 to 6 years). All patients experienced expected myeloablation with engraftment of platelets ( 20 K/µL) and neutrophils ( 500/µL), occurring at a median of 9 and 15 days after ASCT, respectively. There were no treatment-related deaths, and only two patients experienced grade 4 nonhematologic toxicity.

Conclusion: Myeloablative RIT and ASCT is a safe and effective therapeutic option for older adults with relapsed B-NHL.

published online ahead of print at www.jco.org on February 20, 2007.

Supported by Grants No. P01CA44991, K23CA85479, KO8CA95448, from the National Cancer Institute, the Lymphoma Research Foundation Mantle Cell Lymphoma Research Initiative, and a gift from Frank and Betty Vandermeer. J.M.P. is a recipient of Lymphoma Research Foundation Career Development award and a Scholar of the Damon Runyon Cancer Research Foundation.

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

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