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 Elmer Witzig, Stewart Spies, Nancy L. Bartlett, Russell J. Schilder, James L. Murray, Mansoor Saleh, Roberta S. Allen, Antonio J. Grillo-López, Christine A. White

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Abstract

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 111ln 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.

Original languageEnglish (US)
Pages (from-to)4336-4342
Number of pages7
JournalBlood
Volume99
Issue number12
DOIs
StatePublished - Jun 15 2002

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Radioimmunotherapy
Thrombocytopenia
Refractory materials
Non-Hodgkin's Lymphoma
Multicenter Studies
Dosimetry
Follicular Lymphoma
Chemotherapy
B-Cell Lymphoma
Platelets
Neutropenia
Toxicity
Anemia
Bone
Blood Platelets
Bone Marrow
Cells
ibritumomab tiuxetan
Radiation
Safety

ASJC Scopus subject areas

  • Hematology

Cite this

Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia : A phase II multicenter trial. / Wiseman, Gregory A.; Gordon, Leo I.; Multani, Pratik S.; Witzig, Thomas Elmer; Spies, Stewart; Bartlett, Nancy L.; Schilder, Russell J.; Murray, James L.; Saleh, Mansoor; Allen, Roberta S.; Grillo-López, Antonio J.; White, Christine A.

In: Blood, Vol. 99, No. 12, 15.06.2002, p. 4336-4342.

Research output: Contribution to journalArticle

Wiseman, GA, Gordon, LI, Multani, PS, Witzig, TE, Spies, S, Bartlett, NL, Schilder, RJ, Murray, JL, Saleh, M, Allen, RS, Grillo-López, AJ & White, CA 2002, 'Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia: A phase II multicenter trial', Blood, vol. 99, no. 12, pp. 4336-4342. https://doi.org/10.1182/blood.V99.12.4336
Wiseman, Gregory A. ; Gordon, Leo I. ; Multani, Pratik S. ; Witzig, Thomas Elmer ; Spies, Stewart ; Bartlett, Nancy L. ; Schilder, Russell J. ; Murray, James L. ; Saleh, Mansoor ; Allen, Roberta S. ; Grillo-López, Antonio J. ; White, Christine A. / Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia : A phase II multicenter trial. In: Blood. 2002 ; Vol. 99, No. 12. pp. 4336-4342.
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abstract = "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 111ln 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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AU - Schilder, Russell J.

AU - Murray, James L.

AU - Saleh, Mansoor

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N2 - 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 111ln 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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