Originally published as JCO Early Release 10.1200/JCO.2005.05.3470 on August 28 2006

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Multicenter Phase II Clinical Study of Iodine-131–Rituximab Radioimmunotherapy in Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma

Michael F. Leahy, John F. Seymour, Rodney J. Hicks, J. Harvey Turner

From the University of Western Australia, Fremantle Hospital, Fremantle, Western Australia; and Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Address reprint requests to Michael F. Leahy, MD, Department of Haematology, Fremantle Hospital, Alma St, Fremantle WA 6160, Australia; e-mail: Michael.Leahy{at}health.wa.gov.au

PURPOSE: To evaluate efficacy and safety of iodine-131 (¹³¹I) –rituximab chimeric anti-CD20 antibody radioimmunotherapy in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL).

PATIENTS AND METHODS: After a standard loading dose of rituximab 375 mg/m², individualized dosimetry was performed by whole-body gamma imaging of a tracer activity of ¹³¹I-rituximab followed by administration of a therapeutic activity of ¹³¹I-rituximab to deliver an estimated whole-body radiation absorbed dose of 0.75 Gy.

RESULTS: Ninety-one patients were entered onto the trial: 78 patients (86%) had follicular lymphoma, six patients (7%) had mucosa-associated lymphoid tissue/marginal zone lymphoma, and seven patients (8%) had small lymphocytic lymphoma. The objective overall response rate (ORR) was 76%, with 53% attaining a complete response (CR) or CR unconfirmed (CRu). Median duration of response for patients achieving CR/CRu was 20 v 7 months for those with a partial response (P = .0121). Median progression-free survival for the entire cohort was 13 months, with 14% remaining relapse free beyond 4 years. Median follow-up was 23 months, with a 4-year actuarial survival rate of 59% ± 10%. Toxicity was principally hematologic; grade 4 thrombocytopenia occurred in 4% and neutropenia occurred in 16% of patients, with nadirs at 6 to 7 weeks after treatment.

CONCLUSION: ¹³¹I-rituximab radioimmunotherapy of relapsed or refractory indolent NHL achieves high ORR and CR rates with minimal toxicity.

published online ahead of print at www.jco.org on August 28, 2006.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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