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Blood, 15 June 2005, Vol. 105, No. 12, pp. 4576-4582.
Prepublished online as a Blood First Edition Paper on February 24, 2005; DOI 10.1182/blood-2004-12-4690.
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Submitted December 8, 2004
Accepted February 3, 2005
Assessment of treatment-related myelodysplastic syndromes and acute myeloid leukemia in patients with non-Hodgkin's lymphoma treated with Tositumomab and Iodine I 131 Tositumomab (BEXXAR®)
John M Bennett*, Mark S Kaminski, John P Leonard, Julie M Vose, Andrew D Zelenetz, Susan J Knox, Sandra Horning, Oliver W Press, John A Radford, Stewart M Kroll, and Robert L Capizzi
James P. Wilmot Cancer Center, University of Rochester School of Medicine, Rochester, NY, USA
University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA
New York Presbyterian Hospital, Cornell University, New York, NY, USA
University of Nebraska Medical Center, Omaha, NE, USA
Memorial-Sloan Kettering Cancer Center, New York, NY, USA
Stanford University School of Medicine, Palo Alto, CA, USA
Fred Hutchinson Cancer Research Center, Seattle, WA, USA
Christie Hospital N.H.S. Trust, Manchester, England
Corixa Corporation, South San Francisco, CA, USA
Department of Medicine, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA, USA
* Corresponding author; email: john_bennett{at}urmc.rochester.edu.
The incidence of treatment-related myelodysplastic syndromes and acute myeloid leukemia (tMDS/tAML) after Tositumomab and Iodine I 131 Tositumomab administration to previously treated and untreated patients with non-Hodgkin's lymphoma (NHL) was evaluated. Seven studies enrolled 1,071 patients: 995 with relapsed/refractory low-grade NHL, ± transformation (median, 3 prior regimens [range, 1-13]) and 76 patients with previously untreated low-grade follicular NHL. A single dose of Iodine Tositumomab and I 131 Tositumomab was administered. For tMDS/tAML patients, baseline and post-therapy peripheral blood and marrow specimens were reviewed in a blinded fashion. Median follow-up was 6 years from diagnosis and 2 years from radioimmunotherapy for previously treated patients, and 4.6 years from radioimmunotherapy for previously untreated patients. tMDS/tAML was reported in 35/995 (3.5%) patients (annualized incidence, 1.6%/yr [95% confidence interval, 1.0%-2.0%/yr]), and 52% of the tMDS/tAML diagnoses of tMDS/tAML were confirmed in a blinded review (annualized incidence of 1.1%/yr (95% confidence interval, 0.7%-1.6%/yr]). Of the 25 cases ten patients (40%) were diagnosed with tMDS/tAML prior to receiving radioimmunotherapy; two (8%) had no pathologic or clinical evidence to support such a diagnosis and thirteen (52%) were confirmed to have developed tMDS/TAML following RIT. This incidence is consistent with that expected on the basis of patients' prior chemotherapy for NHL. With a median follow-up approaching 5 years, no case of tMDS/tAML has been reported in any of the 76 patients receiving Iodine I 131 Tositumomab as their initial therapy (P =.011 compared with previously treated patients).
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