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Blood, 12 February 2009, Vol. 113, No. 7, pp. 1412-1421.
Prepublished online as a Blood First Edition Paper on December 12, 2008; DOI 10.1182/blood-2008-08-175653.
 Previous Article | Next Article 
Submitted August 27, 2008
Accepted October 17, 2008
Phase I/II study of fractionated 131I-rituximab in low grade B-cell lymphoma: The effect of prior rituximab dosing and tumor burden on subsequent radioimmunotherapy
Tim M Illidge*, Mike Bayne, Nicholas S Brown, Samantha Chilton, Mark S Cragg, Martin J Glennie, Yong Du, Valerie Lewington, James Smart, James Thom, Maureen Zivanovic, and Peter W. M. Johnson
School of Cancer and Imaging Sciences, University of Manchester, Manchester, United Kingdom
Department of Clinical Oncology, Poole Hospital NHS Trust, Poole, United Kingdom
Cancer Sciences Division, School of Medicine, University of Southampton, Southampton General Hospital, Southampton, United Kingdom
Institute of Nuclear Medicine, University College London Hospitals NHS Foundation Trust, London, United Kingdom
Department of Nuclear Medicine, The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Department of Nuclear Medicine, Southampton University Hospitals NHS Trust, Southampton, United Kingdom
Department of Nuclear Medicine, Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
* Corresponding author; email: tmi{at}manchester.ac.uk.
The effect of induction therapy with multiple doses of rituximab on the subsequent efficacy and toxicity of anti-CD20 radioimmunotherapy (RIT) are unknown. We evaluated a novel protocol using 4 weekly infusions of 375 mg/m2 rituximab followed by two fractions of 131I-rituximab, preceded by a 100mg/m2 predose of rituximab, in relapsed indolent B-cell lymphoma. Induction therapy with rituximab significantly increased the effective half-life of 131I-rituximab (P = 0.0033) and high serum levels of rituximab after induction therapy correlated with increased effective half-life of the radioimmunoconjugate (P = 0.0088). Patients with large tumor burdens experienced significant increases in the effective half-life of 131I-rituximab between delivery of the first and second fractions (P = 0.007). Induction therapy with multiple doses of rituximab did not appear to compromise the clinical efficacy or increase toxicity of subsequent 131I-rituximab RIT. The overall response rate (ORR) was 94%, with complete response (CR) rate 50%. The median time to progression was 20 months, significantly longer than for the last qualifying chemotherapy (P = 0.0006). Fractionation of 131I-rituximab allowed cumulative whole body doses of over 120 cGy, around 60% greater than those previously achieved with a single administration of a murine radioimmunconjugate, to be delivered without significant hematological toxicity.
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