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Blood, 15 August 2000, Vol. 96, No. 4, pp. 1259-1266

CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Radioimmunotherapy with iodine 131I tositumomab for relapsed or refractory B-cell non-Hodgkin lymphoma: updated results and long-term follow-up of the University of Michigan experience

Mark S. Kaminski, Judith Estes, Kenneth R. Zasadny, Isaac R. Francis, Charles W. Ross, Melissa Tuck, Denise Regan, Susan Fisher, Jeanne Gutierrez, Stewart Kroll, Robert Stagg, George Tidmarsh, and Richard L. Wahl

From the Divisions of Hematology/Oncology and Nuclear Medicine, Departments of Internal Medicine, Radiology and Pathology, University of Michigan, Ann Arbor, MI; and Coulter Pharmaceutical, Inc, South San Francisco, CA.

CD20-targeted radioimmunotherapy is a promising new treatment for B-cell non-Hodgkin lymphoma (NHL). We now provide updated and long-term data on 59 chemotherapy-relapsed/refractory patients treated with iodine 131I tositumomab in a phase I/II single-center study. Fifty-three patients received individualized therapeutic doses, delivering a specified total-body radiation dose (TBD) based on the clearance rate of a preceding dosimetric dose. Six patients received dosimetric doses only. Dose-escalations of TBD were conducted separately in patients who had or had not undergone a prior autologous stem cell transplant (ASCT) until a nonmyeloablative maximally tolerated TBD was established (non-ASCT = 75 cGy, post-ASCT = 45 cGy). Fourteen additional non-ASCT patients were treated with 75 cGy. Unlabeled antibody was given prior to labeled dosimetric and therapeutic doses to improve biodistribution. Forty-two (71%) of 59 patients responded; 20 (34%) had complete responses (CR). Thirty-five (83%) of 42 with low-grade or transformed NHL responded versus 7 (41%) of 17 with de novo intermediate-grade NHL (P = .005). For all 42 responders, the median progression-free survival was 12 months, 20.3 for those with CR. Seven patients remain in CR 3 to 5.7 years. Sixteen patients were re-treated after progression; 9 responded and 5 had a CR. Reversible hematologic toxicity was dose limiting. Only 10 patients (17%) had human anti-mouse antibodies detected. Long-term, 5 patients developed elevated thyroid-stimulating hormone levels, 5 were diagnosed with myelodysplasia and 3 with solid tumors. A single, well-tolerated treatment with iodine 131I tositumomab can, therefore, produce frequent and durable responses in NHL, especially low-grade or transformed NHL.

© 2000 by The American Society of Hematology.
 

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J. O. Armitage, P. P. Carbone, J. M. Connors, A. Levine, J. M. Bennett, and S. Kroll
Treatment-Related Myelodysplasia and Acute Leukemia in Non-Hodgkin's Lymphoma Patients
J. Clin. Oncol., March 1, 2003; 21(5): 897 - 906.
[Abstract] [Full Text] [PDF]


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G. Sgouros, S. Squeri, A. M. Ballangrud, K. S. Kolbert, J. B. Teitcher, K. S. Panageas, R. D. Finn, C. R. Divgi, S. M. Larson, and A. D. Zelenetz
Patient-Specific, 3-Dimensional Dosimetry in Non-Hodgkin's Lymphoma Patients Treated with 131I-anti-B1 Antibody: Assessment of Tumor Dose-Response
J. Nucl. Med., February 1, 2003; 44(2): 260 - 268.
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BloodHome page
M. S. Cragg, S. M. Morgan, H. T. C. Chan, B. P. Morgan, A. V. Filatov, P. W. M. Johnson, R. R. French, and M. J. Glennie
Complement-mediated lysis by anti-CD20 mAb correlates with segregation into lipid rafts
Blood, February 1, 2003; 101(3): 1045 - 1052.
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B. D. Cheson
Radioimmunotherapy of non-Hodgkin lymphomas
Blood, January 15, 2003; 101(2): 391 - 398.
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JNMHome page
G. L. Griffiths, S. V. Govindan, R. M. Sharkey, D. R. Fisher, and D. M. Goldenberg
90Y-DOTA-hLL2: An Agent for Radioimmunotherapy of Non-Hodgkin's Lymphoma
J. Nucl. Med., January 1, 2003; 44(1): 77 - 84.
[Abstract] [Full Text] [PDF]


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JNMHome page
M. E. Juweid
Radioimmunotherapy of B-Cell Non-Hodgkin's Lymphoma: From Clinical Trials to Clinical Practice
J. Nucl. Med., November 1, 2002; 43(11): 1507 - 1529.
[Abstract] [Full Text] [PDF]


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Clin. Cancer Res.Home page
D. R. Colnot, G. J. Ossenkoppele, J. C. Roos, J. J. Quak, R. de Bree, P. K. Borjesson, P. C. Huijgens, G. B. Snow, and G. A. M. S. van Dongen
Reinfusion of Unprocessed, Granulocyte Colony-stimulating Factor-stimulated Whole Blood Allows Dose Escalation of 186Relabeled Chimeric Monoclonal Antibody U36 Radioimmunotherapy in a Phase I Dose Escalation Study
Clin. Cancer Res., November 1, 2002; 8(11): 3401 - 3406.
[Abstract] [Full Text] [PDF]


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J. Nucl. Med. Technol.Home page
D. W. Seldin
Techniques for Using Bexxar for the Treatment of Non-Hodgkin's Lymphoma*
J. Nucl. Med. Technol., September 1, 2002; 30(3): 109 - 114.
[Abstract] [Full Text] [PDF]


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R. O. Dillman
Radiolabeled Anti-CD20 Monoclonal Antibodies for the Treatment of B-Cell Lymphoma
J. Clin. Oncol., August 15, 2002; 20(16): 3545 - 3557.
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M. Hunault-Berger, N. Ifrah, and P. Solal-Celigny
Intensive therapies in follicular non-Hodgkin lymphomas
Blood, July 30, 2002; 100(4): 1141 - 1152.
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J. G. Jurcic, S. M. Larson, G. Sgouros, M. R. McDevitt, R. D. Finn, C. R. Divgi, A. M. Ballangrud, K. A. Hamacher, D. Ma, J. L. Humm, et al.
Targeted alpha particle immunotherapy for myeloid leukemia
Blood, July 30, 2002; 100(4): 1233 - 1239.
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The OncologistHome page
P. McLaughlin
Progress and Promise in the Treatment of Indolent Lymphomas
Oncologist, June 1, 2002; 7(3): 217 - 225.
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G. A. Wiseman, L. I. Gordon, P. S. Multani, T. E. Witzig, S. Spies, N. L. Bartlett, R. J. Schilder, J. L. Murray, M. Saleh, R. S. Allen, et al.
Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia: a phase II multicenter trial
Blood, May 29, 2002; 99(12): 4336 - 4342.
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T. E. Witzig, L. I. Gordon, F. Cabanillas, M. S. Czuczman, C. Emmanouilides, R. Joyce, B. L. Pohlman, N. L. Bartlett, G. A. Wiseman, N. Padre, et al.
Randomized Controlled Trial of Yttrium-90-Labeled Ibritumomab Tiuxetan Radioimmunotherapy Versus Rituximab Immunotherapy for Patients With Relapsed or Refractory Low-Grade, Follicular, or Transformed B-Cell Non-Hodgkin's Lymphoma
J. Clin. Oncol., May 15, 2002; 20(10): 2453 - 2463.
[Abstract] [Full Text] [PDF]


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D. M. Goldenberg
Targeted Therapy of Cancer with Radiolabeled Antibodies
J. Nucl. Med., May 1, 2002; 43(5): 693 - 713.
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J. A. Siegel, S. Kroll, D. Regan, M. S. Kaminski, and R. L. Wahl
A Practical Methodology for Patient Release After Tositumomab and 131I-Tositumomab Therapy
J. Nucl. Med., March 1, 2002; 43(3): 354 - 363.
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Cancer Res.Home page
H. Kobayashi, K. Shirakawa, S. Kawamoto, T. Saga, N. Sato, A. Hiraga, I. Watanabe, Y. Heike, K. Togashi, J. Konishi, et al.
Rapid Accumulation and Internalization of Radiolabeled Herceptin in an Inflammatory Breast Cancer Xenograft with Vasculogenic Mimicry Predicted by the Contrast-enhanced Dynamic MRI with the Macromolecular Contrast Agent G6-(1B4M-Gd)256
Cancer Res., February 1, 2002; 62(3): 860 - 866.
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J. M. Vose, B. C.-H. Chiu, B. D. Cheson, J. Dancey, and J. Wright
Update on Epidemiology and Therapeutics for Non-Hodgkin's Lymphoma
Hematology, January 1, 2002; 2002(1): 241 - 262.
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O. W. Press, M. Corcoran, K. Subbiah, D. K. Hamlin, D. S. Wilbur, T. Johnson, L. Theodore, E. Yau, R. Mallett, D. L. Meyer, et al.
A comparative evaluation of conventional and pretargeted radioimmunotherapy of CD20-expressing lymphoma xenografts
Blood, October 15, 2001; 98(8): 2535 - 2543.
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B. D. Cheson
Some Like It Hot!
J. Clin. Oncol., October 1, 2001; 19(19): 3908 - 3911.
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M. S. Kaminski, A. D. Zelenetz, O. W. Press, M. Saleh, J. Leonard, L. Fehrenbacher, T. A. Lister, R. J. Stagg, G. F. Tidmarsh, S. Kroll, et al.
Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-Refractory Low-Grade or Transformed Low-Grade B-Cell Non-Hodgkin's Lymphomas
J. Clin. Oncol., October 1, 2001; 19(19): 3918 - 3928.
[Abstract] [Full Text]


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S. L. McCune, J. P. Gockerman, and D. A. Rizzieri
Monoclonal Antibody Therapy in the Treatment of Non-Hodgkin Lymphoma
JAMA, September 12, 2001; 286(10): 1149 - 1152.
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O. W. Press, J. P. Leonard, B. Coiffier, R. Levy, and J. Timmerman
Immunotherapy of Non-Hodgkin's Lymphomas
Hematology, January 1, 2001; 2001(1): 221 - 240.
[Abstract] [Full Text] [PDF]



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