Originally published as JCO Early Release 10.1200/JCO.2004.00.9217 on September 26 2005

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Tositumomab and Iodine-131 Tositumomab Produces Durable Complete Remissions in a Subset of Heavily Pretreated Patients With Low-Grade and Transformed Non-Hodgkin’s Lymphomas

From the James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester; Memorial-Sloan-Kettering Cancer Center; Weill Medical College of Cornell University, New York, NY; University of Michigan Cancer Center, Ann Arbor, MI; Johns Hopkins School of Medicine, Baltimore, MD; Stanford University Medical Center, Stanford, CA; University of Nebraska Medical Center, Omaha, NE; Corixa Corporation, Seattle, WA

Address reprint requests to Richard I. Fisher, MD, University of Rochester School of Medicine, James P. Wilmot Cancer Center, 601 Elmwood Ave, Box 704, Rochester, NY 14642; e-mail: richard_fisher{at}urmc.rochester.edu

PURPOSE: This study is an integrated efficacy analysis of the five clinical trials of tositumomab and iodine-131 tositumomab in patients with relapsed or refractory low-grade, follicular, or transformed low-grade non-Hodgkin’s lymphoma (NHL) that resulted in the regulatory approval of the iodine-131 tositumomab by the US Food and Drug Administration.

PATIENTS AND METHODS: This integrated analysis included 250 patients. Patients received a single course of iodine-131 tositumomab. Responses were assessed by an independent panel of radiologists and oncologists.

RESULTS: Response rates in the five trials ranged from 47% to 68%; complete response rates ranged from 20% to 38%. With a median follow-up of 5.3 years, the 5-year progression-free survival was 17%. Eighty-one (32%) of 250 patients had a time to progression of 1 year (termed durable response population). For the durable response population, 44% had not progressed at 2.5 to 9.5 years and had a median duration of response of 45.8 months. The median duration of complete response was not reached. The durable response population had many poor prognostic characteristics, including bone marrow involvement (41%), bulky disease 5 cm (49%), and transformed histology (23%). Forty-three percent of the patients had been treated with more than four prior therapies and 36% had not responded to their most recent therapy.

CONCLUSION: The tositumomab and iodine-131 tositumomab therapeutic regimen produces high response rates in patients with relapsed or refractory low-grade, follicular, and transformed low-grade NHL, with a sizable subgroup of patients achieving long-term durable responses.

Supported by Corixa and GlaxoSmithKline, in the conduct of the research reported in this article.

This original manuscript has not been previously published.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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