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Blood, 15 June 2002, Vol. 99, No. 12, pp. 4336-4342
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Ibritumomab tiuxetan radioimmunotherapy for patients with
relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia:
a phase II multicenter trial
Gregory A. Wiseman,
Leo I. Gordon,
Pratik S. Multani,
Thomas E. Witzig,
Stewart Spies,
Nancy L. Bartlett,
Russell J. Schilder,
James L. Murray,
Mansoor Saleh,
Roberta S. Allen,
Antonio J. Grillo-López, and
Christine A. White
From the Mayo Clinic, Rochester, MN; the Division of
Hematology/Oncology and Robert H. Lurie Comprehensive Cancer Center of
Northwestern University, Chicago, IL; IDEC Pharmaceuticals Corporation,
San Diego, CA; the Washington University, St Louis, MO; Fox Chase
Cancer, Philadelphia, PA; MD Anderson Cancer Center, Houston, TX; and
the University of Alabama, Birmingham, AL.
Mildly thrombocytopenic patients with relapsed or refractory
low-grade non-Hodgkin lymphoma (NHL) have an increased risk of chemotherapy-induced myelosuppression following treatment. The safety
and efficacy of radioimmunotherapy with a reduced dose of
90Y ibritumomab tiuxetan (0.3 mCi/kg [11 MBq/kg]; maximum
32 mCi [1.2 GBq]) was evaluated in 30 patients with mild
thrombocytopenia (100-149 × 109 platelets/L) who had
advanced, relapsed or refractory, low-grade, follicular, or transformed
B-cell NHL. The ibritumomab tiuxetan regimen included an infusion of
rituximab (250 mg/m2) and injection of 111In
ibritumomab tiuxetan (5 mCi [185 MBq]) for dosimetry evaluation, followed 1 week later with rituximab (250 mg/m2) and
90Y ibritumomab tiuxetan (0.3 mCi/kg [11 MBq/kg]).
Patients (median age, 61 years; 90% stage III/IV at study entry; 83%
follicular lymphoma; and 67% with bone marrow involvement) had a
median of 2 prior therapy regimens (range, 1-9). Estimated
radiation-absorbed doses were well below the study-defined maximum
allowable for all 30 patients. With the use of the International
Workshop criteria for NHL response assessment, the overall response
rate was 83% (37% complete response, 6.7% complete response
unconfirmed, and 40% partial response). Kaplan-Meier estimated median
time to progression (TTP) was 9.4 months (range, 1.7-24.6). In
responders, Kaplan-Meier estimated median TTP was 12.6 months (range,
4.9-24.6), with 35% of data censored. Toxicity was primarily
hematologic, transient, and reversible. The incidence of grade 4 neutropenia, thrombocytopenia, and anemia was 33%, 13%, and 3%,
respectively. Reduced-dose ibritumomab tiuxetan is safe and well
tolerated and has significant clinical activity in this patient population.
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