Yttrium 90-labeled ibritumomab tiuxetan radioimmunotherapy produces high response rates and durable remissions in patients with previously treated B-cell lymphoma

Leo I. Gordon, Thomas Elmer Witzig, Arturo Molina, Myron Czuczman, Christos Emmanouilides, Robin Joyce, Katie Vo, Charles Theuer, Brad Pohlman, Nancy Bartlett, Greg Wiseman, Mohamed Darif, Christine White

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Abstract

We report updated time-to-event variables of a phase III randomized study comparing yttrium 90-labeled ibritumomab with rituximab standard therapy in 143 rituximab-naive patients with relapsed or refractory low-grade, follicular, or transformed CD20+ non-Hodgkin's lymphoma (NHL). Most patients (79%) had follicular lymphoma. Patients were randomized to receive a single intravenous (I.V. dose of 90Y ibritumomab tiuxetan 0.4 mCi/kg (n = 73) or rituximab 375 mg/m2 I.V. weekly for 4 doses (n = 70). The radioimmunotherapy group was pretreated with 2 rituximab doses (250 mg/m2) to improve biodistribution and one dose of Indium 111-labeled ibritumomab tiuxetan for imaging. The overall response rate was 80% versus 56% (P = 0.002) and complete response (CR)/CR unconfirmed (CRu) rates were 34% for 90Y ibritumomab tiuxetan versus 20% for rituximab. With a median follow-up of 44 months, the data are mature as all ongoing patients in both groups exceeded the median Kaplan-Meier estimated time to progression (TTP), duration of response (DR), and time to next therapy. Although this study was not powered to detect differences in time-to-event variables, the results from this randomized trial demonstrate trends toward longer median TTP (15 vs. 10.2 months; P = 0.07), DR (16.7 vs. 11.2 months; P = 0.44) and time to next therapy (21.1 vs. 13.8 months; P = 0.27) in follicular NHL patients treated with 90Y ibritumomab tiuxetan compared with the rituximab control arm. In patients achieving a CR/CRu, the median TTP was 24.7 months for patients treated with 90Y ibritumomab tiuxetan compared with 13.2 months for rituximab-treated patients (P = 0.41), and ongoing responses of >5 years have been observed. These results confirm that 90Y ibritumomab tiuxetan produces high response rates and durable remissions in patients with previously treated low-grade, follicular, and transformed NHL.

Original languageEnglish (US)
Pages (from-to)98-101
Number of pages4
JournalClinical Lymphoma
Volume5
Issue number2
StatePublished - Sep 2004

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Radioimmunotherapy
B-Cell Lymphoma
Non-Hodgkin's Lymphoma
Follicular Lymphoma
Yttrium
ibritumomab tiuxetan
Indium
Rituximab
Reaction Time
Therapeutics

Keywords

  • Biodistribution
  • Follicular lymphoma
  • Non-Hodgkin's lymphoma
  • Rituximab

ASJC Scopus subject areas

  • Cancer Research

Cite this

Yttrium 90-labeled ibritumomab tiuxetan radioimmunotherapy produces high response rates and durable remissions in patients with previously treated B-cell lymphoma. / Gordon, Leo I.; Witzig, Thomas Elmer; Molina, Arturo; Czuczman, Myron; Emmanouilides, Christos; Joyce, Robin; Vo, Katie; Theuer, Charles; Pohlman, Brad; Bartlett, Nancy; Wiseman, Greg; Darif, Mohamed; White, Christine.

In: Clinical Lymphoma, Vol. 5, No. 2, 09.2004, p. 98-101.

Research output: Contribution to journalArticle

Gordon, LI, Witzig, TE, Molina, A, Czuczman, M, Emmanouilides, C, Joyce, R, Vo, K, Theuer, C, Pohlman, B, Bartlett, N, Wiseman, G, Darif, M & White, C 2004, 'Yttrium 90-labeled ibritumomab tiuxetan radioimmunotherapy produces high response rates and durable remissions in patients with previously treated B-cell lymphoma', Clinical Lymphoma, vol. 5, no. 2, pp. 98-101.
Gordon, Leo I. ; Witzig, Thomas Elmer ; Molina, Arturo ; Czuczman, Myron ; Emmanouilides, Christos ; Joyce, Robin ; Vo, Katie ; Theuer, Charles ; Pohlman, Brad ; Bartlett, Nancy ; Wiseman, Greg ; Darif, Mohamed ; White, Christine. / Yttrium 90-labeled ibritumomab tiuxetan radioimmunotherapy produces high response rates and durable remissions in patients with previously treated B-cell lymphoma. In: Clinical Lymphoma. 2004 ; Vol. 5, No. 2. pp. 98-101.
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abstract = "We report updated time-to-event variables of a phase III randomized study comparing yttrium 90-labeled ibritumomab with rituximab standard therapy in 143 rituximab-naive patients with relapsed or refractory low-grade, follicular, or transformed CD20+ non-Hodgkin's lymphoma (NHL). Most patients (79{\%}) had follicular lymphoma. Patients were randomized to receive a single intravenous (I.V. dose of 90Y ibritumomab tiuxetan 0.4 mCi/kg (n = 73) or rituximab 375 mg/m2 I.V. weekly for 4 doses (n = 70). The radioimmunotherapy group was pretreated with 2 rituximab doses (250 mg/m2) to improve biodistribution and one dose of Indium 111-labeled ibritumomab tiuxetan for imaging. The overall response rate was 80{\%} versus 56{\%} (P = 0.002) and complete response (CR)/CR unconfirmed (CRu) rates were 34{\%} for 90Y ibritumomab tiuxetan versus 20{\%} for rituximab. With a median follow-up of 44 months, the data are mature as all ongoing patients in both groups exceeded the median Kaplan-Meier estimated time to progression (TTP), duration of response (DR), and time to next therapy. Although this study was not powered to detect differences in time-to-event variables, the results from this randomized trial demonstrate trends toward longer median TTP (15 vs. 10.2 months; P = 0.07), DR (16.7 vs. 11.2 months; P = 0.44) and time to next therapy (21.1 vs. 13.8 months; P = 0.27) in follicular NHL patients treated with 90Y ibritumomab tiuxetan compared with the rituximab control arm. In patients achieving a CR/CRu, the median TTP was 24.7 months for patients treated with 90Y ibritumomab tiuxetan compared with 13.2 months for rituximab-treated patients (P = 0.41), and ongoing responses of >5 years have been observed. These results confirm that 90Y ibritumomab tiuxetan produces high response rates and durable remissions in patients with previously treated low-grade, follicular, and transformed NHL.",
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