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Journal of Clinical Oncology, Vol 19, Issue 19 (October), 2001: 3918-3928
© 2001 American Society for Clinical Oncology

Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-Refractory Low-Grade or Transformed Low-Grade B-Cell Non-Hodgkin’s Lymphomas

By Mark S. Kaminski, Andrew D. Zelenetz, Oliver W. Press, Mansoor Saleh, John Leonard, Louis Fehrenbacher, T. Andrew Lister, Robert J. Stagg, George F. Tidmarsh, Stew Kroll, Richard L. Wahl, Susan J. Knox, Julie M. Vose

From the University of Michigan Medical Center, Ann Arbor, MI; Memorial Sloan-Kettering Cancer Center and Cornell University Medical College, New York, NY; University of Washington Medical Center and Corixa Corporation, Seattle, WA; University of Alabama, Birmingham, AL; Kaiser Northern California, Vallejo; Stanford University Medical Center, Stanford, CA; University of Nebraska Medical Center, Omaha, NE; and St Bartholomew’s Hospital, London, United Kingdom.

Address reprint requests to Mark S. Kaminski, MD, University of Michigan Cancer Center, 1500 E Medical Center Dr, Rm CCGC 4-316, Ann Arbor, MI 48109-0936; email: mkaminsk{at}umich.edu

PURPOSE: To evaluate the efficacy and safety of tositumomab and iodine I 131 tositumomab (Bexxar; Corixa Corp, Seattle, WA, and GlaxoSmithKline, Philadelphia, PA) in patients with chemotherapy-refractory low-grade or transformed low-grade non-Hodgkin’s lymphoma (NHL) and to compare its efficacy to the patients’ last qualifying chemotherapy (LQC) regimens.

PATIENTS AND METHODS: Sixty patients who had been treated with at least two protocol-specified qualifying chemotherapy regimens and had not responded or progressed within 6 months after their LQC were treated with a single course of iodine I 131 tositumomab.

RESULTS: Patients had received a median of four prior chemotherapy regimens. A partial or complete response (CR) was observed in 39 patients (65%) after iodine I 131 tositumomab, compared with 17 patients (28%) after their LQC (P < .001). The median duration of response (MDR) was 6.5 months after iodine I 131 tositumomab, compared with 3.4 months after the LQC (P < .001). Two patients (3%) had a CR after their LQC, compared with 12 (20%) after iodine I 131 tositumomab (P < .001). The MDR for CR was 6.1 months after the LQC and had not been reached with follow-up of more than 47 months after iodine I 131 tositumomab. An independent review panel verified that 32 (74%) of the 43 patients with nonequivalent durations of response (> 30 days difference) had a longer duration of response after iodine I 131 tositumomab (P < .001). Only one patient was hospitalized for neutropenic fever. Five patients (8%) developed human antimurine antibodies, and one (2%) developed an elevated TSH level after treatment. Myelodysplasia was diagnosed in four patients in follow-up.

CONCLUSION: A single course of iodine I 131 tositumomab was significantly more efficacious than the LQC received by extensively pretreated patients with chemotherapy-refractory, low-grade, or transformed low-grade NHL and had an acceptable safety profile.




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