Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma

Thomas Elmer Witzig, Leo I. Gordon, Fernando Cabanillas, Myron S. Czuczman, Christos Emmanouilides, Robin Joyce, Brad L. Pohlman, Nancy L. Bartlett, Gregory A. Wiseman, Norman Padre, Antonio J. Grillo-López, Pratik Multani, Christine A. White

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Abstract

Purpose: Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells, thus offering a needed therapeutic alternative for refractory non-Hodgkin's lymphoma (NHL) patients. This phase III randomized study compares the novel radioimmunotherapy yttrium-90 (90Y) ibritumomab tiuxetan with a control immunotherapy, rituximab, in 143 patients with relapsed or refractory low-grade, follicular, or transformed CD20+ transformed NHL. Patients and Methods: Patients received either a single intravenous (IV) dose of 90Y ibritumomab tiuxetan 0.4 mCi/kg (n = 73) or rituximab 375 mg/m2 IV weekly for four doses (n = 70). The radioimmunotherapy group was pretreated with two rituximab doses (250 mg/m2) to improve biodistribution and one dose of indium-111 ibritumomab tiuxetan for imaging and dosimetry. The primary end point, overall response rate (ORR), was assessed by an independent, blinded, lymphoma expert panel. Results: ORR was 80% for the 90Y ibritumomab tiuxetan group versus 56% for the rituximab group (P = .002). Complete response (CR) rates were 30% and 16% in the 90Y ibritumomab tiuxetan and rituximab groups, respectively (P = .04). An additional 4% achieved an unconfirmed CR in each group. Kaplan-Meier estimated median duration of response was 14.2 months in the 90Y ibritumomab tiuxetan group versus 12.1 months in the control group (P = .6), and time to progression was 11.2 versus 10.1 months (P = .173) in all patients. Durable responses of ≥ 6 months were 64% versus 47% (P = .030). Reversible myelosuppression was the primary toxicity noted with 90Y ibritumomab tiuxetan. Conclusion: Radioimmunotherapy with 90Y ibritumomab tiuxetan is well tolerated and produces statistically and clinically significant higher ORR and CR compared with rituximab alone.

Original languageEnglish (US)
Pages (from-to)2453-2463
Number of pages11
JournalJournal of Clinical Oncology
Volume20
Issue number10
DOIs
StatePublished - May 15 2002

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Radioimmunotherapy
B-Cell Lymphoma
Non-Hodgkin's Lymphoma
Immunotherapy
Randomized Controlled Trials
Indium
ibritumomab tiuxetan
Rituximab
Lymphoma
Control Groups

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. / Witzig, Thomas Elmer; Gordon, Leo I.; Cabanillas, Fernando; Czuczman, Myron S.; Emmanouilides, Christos; Joyce, Robin; Pohlman, Brad L.; Bartlett, Nancy L.; Wiseman, Gregory A.; Padre, Norman; Grillo-López, Antonio J.; Multani, Pratik; White, Christine A.

In: Journal of Clinical Oncology, Vol. 20, No. 10, 15.05.2002, p. 2453-2463.

Research output: Contribution to journalArticle

Witzig, TE, Gordon, LI, Cabanillas, F, Czuczman, MS, Emmanouilides, C, Joyce, R, Pohlman, BL, Bartlett, NL, Wiseman, GA, Padre, N, Grillo-López, AJ, Multani, P & White, CA 2002, 'Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma', Journal of Clinical Oncology, vol. 20, no. 10, pp. 2453-2463. https://doi.org/10.1200/JCO.2002.11.076
Witzig, Thomas Elmer ; Gordon, Leo I. ; Cabanillas, Fernando ; Czuczman, Myron S. ; Emmanouilides, Christos ; Joyce, Robin ; Pohlman, Brad L. ; Bartlett, Nancy L. ; Wiseman, Gregory A. ; Padre, Norman ; Grillo-López, Antonio J. ; Multani, Pratik ; White, Christine A. / Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 10. pp. 2453-2463.
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abstract = "Purpose: Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells, thus offering a needed therapeutic alternative for refractory non-Hodgkin's lymphoma (NHL) patients. This phase III randomized study compares the novel radioimmunotherapy yttrium-90 (90Y) ibritumomab tiuxetan with a control immunotherapy, rituximab, in 143 patients with relapsed or refractory low-grade, follicular, or transformed CD20+ transformed NHL. Patients and Methods: Patients received either a single intravenous (IV) dose of 90Y ibritumomab tiuxetan 0.4 mCi/kg (n = 73) or rituximab 375 mg/m2 IV weekly for four doses (n = 70). The radioimmunotherapy group was pretreated with two rituximab doses (250 mg/m2) to improve biodistribution and one dose of indium-111 ibritumomab tiuxetan for imaging and dosimetry. The primary end point, overall response rate (ORR), was assessed by an independent, blinded, lymphoma expert panel. Results: ORR was 80{\%} for the 90Y ibritumomab tiuxetan group versus 56{\%} for the rituximab group (P = .002). Complete response (CR) rates were 30{\%} and 16{\%} in the 90Y ibritumomab tiuxetan and rituximab groups, respectively (P = .04). An additional 4{\%} achieved an unconfirmed CR in each group. Kaplan-Meier estimated median duration of response was 14.2 months in the 90Y ibritumomab tiuxetan group versus 12.1 months in the control group (P = .6), and time to progression was 11.2 versus 10.1 months (P = .173) in all patients. Durable responses of ≥ 6 months were 64{\%} versus 47{\%} (P = .030). Reversible myelosuppression was the primary toxicity noted with 90Y ibritumomab tiuxetan. Conclusion: Radioimmunotherapy with 90Y ibritumomab tiuxetan is well tolerated and produces statistically and clinically significant higher ORR and CR compared with rituximab alone.",
author = "Witzig, {Thomas Elmer} and Gordon, {Leo I.} and Fernando Cabanillas and Czuczman, {Myron S.} and Christos Emmanouilides and Robin Joyce and Pohlman, {Brad L.} and Bartlett, {Nancy L.} and Wiseman, {Gregory A.} and Norman Padre and Grillo-L{\'o}pez, {Antonio J.} and Pratik Multani and White, {Christine A.}",
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T1 - Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma

AU - Witzig, Thomas Elmer

AU - Gordon, Leo I.

AU - Cabanillas, Fernando

AU - Czuczman, Myron S.

AU - Emmanouilides, Christos

AU - Joyce, Robin

AU - Pohlman, Brad L.

AU - Bartlett, Nancy L.

AU - Wiseman, Gregory A.

AU - Padre, Norman

AU - Grillo-López, Antonio J.

AU - Multani, Pratik

AU - White, Christine A.

PY - 2002/5/15

Y1 - 2002/5/15

N2 - Purpose: Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells, thus offering a needed therapeutic alternative for refractory non-Hodgkin's lymphoma (NHL) patients. This phase III randomized study compares the novel radioimmunotherapy yttrium-90 (90Y) ibritumomab tiuxetan with a control immunotherapy, rituximab, in 143 patients with relapsed or refractory low-grade, follicular, or transformed CD20+ transformed NHL. Patients and Methods: Patients received either a single intravenous (IV) dose of 90Y ibritumomab tiuxetan 0.4 mCi/kg (n = 73) or rituximab 375 mg/m2 IV weekly for four doses (n = 70). The radioimmunotherapy group was pretreated with two rituximab doses (250 mg/m2) to improve biodistribution and one dose of indium-111 ibritumomab tiuxetan for imaging and dosimetry. The primary end point, overall response rate (ORR), was assessed by an independent, blinded, lymphoma expert panel. Results: ORR was 80% for the 90Y ibritumomab tiuxetan group versus 56% for the rituximab group (P = .002). Complete response (CR) rates were 30% and 16% in the 90Y ibritumomab tiuxetan and rituximab groups, respectively (P = .04). An additional 4% achieved an unconfirmed CR in each group. Kaplan-Meier estimated median duration of response was 14.2 months in the 90Y ibritumomab tiuxetan group versus 12.1 months in the control group (P = .6), and time to progression was 11.2 versus 10.1 months (P = .173) in all patients. Durable responses of ≥ 6 months were 64% versus 47% (P = .030). Reversible myelosuppression was the primary toxicity noted with 90Y ibritumomab tiuxetan. Conclusion: Radioimmunotherapy with 90Y ibritumomab tiuxetan is well tolerated and produces statistically and clinically significant higher ORR and CR compared with rituximab alone.

AB - Purpose: Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells, thus offering a needed therapeutic alternative for refractory non-Hodgkin's lymphoma (NHL) patients. This phase III randomized study compares the novel radioimmunotherapy yttrium-90 (90Y) ibritumomab tiuxetan with a control immunotherapy, rituximab, in 143 patients with relapsed or refractory low-grade, follicular, or transformed CD20+ transformed NHL. Patients and Methods: Patients received either a single intravenous (IV) dose of 90Y ibritumomab tiuxetan 0.4 mCi/kg (n = 73) or rituximab 375 mg/m2 IV weekly for four doses (n = 70). The radioimmunotherapy group was pretreated with two rituximab doses (250 mg/m2) to improve biodistribution and one dose of indium-111 ibritumomab tiuxetan for imaging and dosimetry. The primary end point, overall response rate (ORR), was assessed by an independent, blinded, lymphoma expert panel. Results: ORR was 80% for the 90Y ibritumomab tiuxetan group versus 56% for the rituximab group (P = .002). Complete response (CR) rates were 30% and 16% in the 90Y ibritumomab tiuxetan and rituximab groups, respectively (P = .04). An additional 4% achieved an unconfirmed CR in each group. Kaplan-Meier estimated median duration of response was 14.2 months in the 90Y ibritumomab tiuxetan group versus 12.1 months in the control group (P = .6), and time to progression was 11.2 versus 10.1 months (P = .173) in all patients. Durable responses of ≥ 6 months were 64% versus 47% (P = .030). Reversible myelosuppression was the primary toxicity noted with 90Y ibritumomab tiuxetan. Conclusion: Radioimmunotherapy with 90Y ibritumomab tiuxetan is well tolerated and produces statistically and clinically significant higher ORR and CR compared with rituximab alone.

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