Tositumomab and iodine I 131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin's lymphoma

A J Davies, A Z S Rohatiner, S Howell, K E Britton, S E Owens, I N Micallef, D P Deakin, B M Carrington, J A Lawrance, S Vinnicombe, S J Mather, J Clayton, R Foley, H Jan, S Kroll, M Harris, J Amess, A J Norton, T A Lister, J A Radford

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    Abstract

    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 10(9)/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.

    Original languageEnglish
    Pages (from-to)1469-1479
    Number of pages11
    JournalJournal of Clinical Oncology
    Volume22
    Issue number8
    DOIs
    Publication statusPublished - 15 Apr 2004

    Keywords

    • Adult
    • Aged
    • Antibodies, Monoclonal
    • Antigens, CD20
    • Antineoplastic Agents
    • Humans
    • Immunoconjugates
    • Iodine Radioisotopes
    • Lymphoma, B-Cell
    • Middle Aged
    • Neoplasm Recurrence, Local
    • Radioimmunotherapy
    • Survival Rate
    • Clinical Trial
    • Clinical Trial, Phase II
    • Journal Article
    • Multicenter Study
    • Research Support, Non-U.S. Gov't

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