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Tositumomab and Iodine I 131 Tositumomab for Recurrent Indolent and Transformed B-Cell Non-Hodgkin’s Lymphoma

From the St Bartholomew’s Hospital, London; Christie Hospital, Manchester, United Kingdom; and Corixa Corp, South San Francisco, CA

Address reprint requests to A.J. Davies, BM, Cancer Research UK Medical Oncology Unit, Department of Medical Oncology, 45 Little Britain, St Bartholomew’s Hospital, London EC1A 7BE, United Kingdom; e-mail: Andrew.J.Davies{at}cancer.org.uk

PURPOSE: An open-label phase II study was conducted at two centers to establish the efficacy and safety of tositumomab and iodine I 131 tositumomab at first or second recurrence of indolent or transformed indolent B-cell lymphoma.

PATIENTS AND METHODS: A single dosimetric dose was followed at 7 to 14 days by the patient-specific administered radioactivity required to deliver a total body dose of 0.75 Gy (reduced to 0.65 Gy for patients with platelets counts of 100 to 149 x 10⁹/L). Forty of 41 patients received both infusions.

RESULTS: Thirty-one of 41 patients (76%) responded, with 20 patients (49%) achieving either a complete (CR) or unconfirmed complete remission [CR(u)] and 11 patients (27%) achieving a partial remission. Response rates were similar in both indolent (76%) and transformed disease (71%). The overall median duration of remission was 1.3 years. The median duration of remission has not yet been reached for those patients who achieved a CR or CR(u). Eleven patients continue in CR or CR(u) between 2.6+ and 5.2+ years after therapy. Therapy was well tolerated; hematologic toxicity was the principal adverse event. Grade 3 or 4 anemia, neutropenia, and thrombocytopenia were observed in 5%, 45%, and 32% of patients, respectively. Secondary myelodysplasia has occurred in one patient. Four patients developed human antimouse antibodies after therapy. Five of 38 assessable patients have developed an elevated thyroid-stimulating hormone; treatment with thyroxine has been initiated in one patient.

CONCLUSION: High overall and CR rates were observed after a single dose of tositumomab and iodine I 131 tositumomab in this patient group. Toxicity was modest and easily managed.

Supported by Corixa Corp (South San Francisco, CA), Cancer Research UK, Barts and the London NHS Trust, and Christie Hospital NHS Trust, United Kingdom.

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

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