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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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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Assessment of treatment-related myelodysplastic syndromes and acute myeloid leukemia in patients with non-Hodgkin lymphoma treated with tositumomab and iodine I131 tositumomab
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
From the James P. Wilmot Cancer Center, University of Rochester School of Medicine, Rochester, NY; the University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; New York Presbyterian Hospital at Cornell University, New York, NY; the University of Nebraska Medical Center, Omaha, NE; Memorial-Sloan Kettering Cancer Center, New York, NY; Stanford University School of Medicine, Palo Alto, CA; the Fred Hutchinson Cancer Research Center, Seattle, WA; Christie Hospital National Health Service (NHS) Trust, Manchester, England; Corixa, South San Francisco, CA; and the Department of Medicine, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA.
The incidence of treatment-related myelodysplastic syndromes and acute myeloid leukemia (tMDSs/tAML) after tositumomab and iodine I131 tositumomab administration to previously treated and untreated patients with non-Hodgkin lymphoma (NHL) was evaluated. A total of 1071 patients were enrolled in 7 studies: 995 with relapsed/refractory low-grade NHL, ± transformation (median, 3 prior regimens [range, 1-13 regimens]) and 76 patients with previously untreated low-grade follicular NHL. A single dose of iodine tositumomab and I131 tositumomab was administered. For tMDS/tAML patients, baseline and posttherapy peripheral blood and marrow specimens were reviewed in a blinded fashion. Median follow-up was 6 years from diagnosis and 2 years from radioimmunotherapy (RIT) for previously treated patients, and 4.6 years from radioimmunotherapy for previously untreated patients. tMDS/tAML was reported in 35 (3.5%) of 995 patients (annualized incidence, 1.6%/y [95% confidence interval, 1.0%-2.0%/y]), and 52% of the tMDS/tAML diagnoses of tMDS/tAML were confirmed in a blinded review (annualized incidence of 1.1%/y [95% confidence interval, 0.7%-1.6%/y]). Of the 25 cases, 10 patients (40%) were diagnosed with tMDS/tAML prior to receiving radioimmunotherapy; 2 (8%) had no pathologic or clinical evidence to support such a diagnosis; and 13 (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 I131 tositumomab as their initial therapy (P = .011 compared with previously treated patients). (Blood. 2005;105:4576-4582)
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