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Blood, 1 November 2000, Vol. 96, No. 9, pp. 2934-2942

PLENARY PAPER

A phase I/II trial of iodine-131-tositumomab (anti-CD20), etoposide, cyclophosphamide, and autologous stem cell transplantation for relapsed B-cell lymphomas

Oliver W. Press, Janet F. Eary, Ted Gooley, Ajay K. Gopal, Stephen Liu, Joseph G. Rajendran, David G. Maloney, Stephen Petersdorf, Sharon A. Bush, Lawrence D. Durack, Paul J. Martin, Darrell R. Fisher, Brent Wood, James W. Borrow, Bruce Porter, Justin P. Smith, Dana C. Matthews, Frederick R. Appelbaum, and Irwin D. Bernstein

From the Departments of Medicine, Pathology, Pediatrics, Radiology, Biological Structure, and Biostatistics, the University of Washington, Seattle, WA; the Fred Hutchinson Cancer Research Center, Seattle, WA; First Hill Diagnostic Imaging, Richland, WA; and Pacific Northwest National Laboratory, Richland, WA.

Relapsed B-cell lymphomas are incurable with conventional chemotherapy and radiation therapy, although a fraction of patients can be cured with high-dose chemoradiotherapy and autologous stem-cell transplantation (ASCT). We conducted a phase I/II trial to estimate the maximum tolerated dose (MTD) of iodine 131 (131I)-tositumomab (anti-CD20 antibody) that could be combined with etoposide and cyclophosphamide followed by ASCT in patients with relapsed B-cell lymphomas. Fifty-two patients received a trace-labeled infusion of 1.7 mg/kg 131I-tositumomab (185-370 MBq) followed by serial quantitative gamma-camera imaging and estimation of absorbed doses of radiation to tumor sites and normal organs. Ten days later, patients received a therapeutic infusion of 1.7 mg/kg tositumomab labeled with an amount of 131I calculated to deliver the target dose of radiation (20-27 Gy) to critical normal organs (liver, kidneys, and lungs). Patients were maintained in radiation isolation until their total-body radioactivity was less than 0.07 mSv/h at 1 m. They were then given etoposide and cyclophosphamide followed by ASCT. The MTD of 131I-tositumomab that could be safely combined with 60 mg/kg etoposide and 100 mg/kg cyclophosphamide delivered 25 Gy to critical normal organs. The estimated overall survival (OS) and progression-free survival (PFS) of all treated patients at 2 years was 83% and 68%, respectively. These findings compare favorably with those in a nonrandomized control group of patients who underwent transplantation, external-beam total-body irradiation, and etoposide and cyclophosphamide therapy during the same period (OS of 53% and PFS of 36% at 2 years), even after adjustment for confounding variables in a multivariable analysis.

© 2000 by The American Society of Hematology.
 

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