Phase 2 study of iodine-131 tositumomab plus chemotherapy in patients with previously untreated mantle-cell lymphoma Journal Article

Authors: Zelenetz, A. D.; Popplewell, L. L.; Noy, A.; Horner, T. J.; Lin, T. S.; Donnelly, G.; Sgouros, G.; Rijo, I.; Divgi, C. R.
Article Title: Phase 2 study of iodine-131 tositumomab plus chemotherapy in patients with previously untreated mantle-cell lymphoma
Abstract: Background: Mantle-cell lymphoma (MCL) is sensitive to radiotherapy, and the CD20 antigen is relatively highly expressed in MCL. Therefore, radioimmunotherapy using radiolabeled anti-CD20 monoclonal antibodies has the potential to treat MCL. The objective of this study was to investigate the efficacy, pharmacokinetics, and safety of tositumomab (TST) and iodine-131 tositumomab (I-131 TST) followed by 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with previously untreated MCL ( NCT00022945). Patients and Methods: In this phase 2 open-label study, patients received dosimetric (day 0: 450 mg TST, then 35 mg I-131 TST [5 mCi]) and therapeutic (between days 7 and 14: 450 mg TST, then an individualized dose of I-131 TST [65-75 cGy]) TST/I-131 TST, with CHOP treatment commencing approximately 13 weeks after the therapeutic dose. The primary end point was the MCL response rate to treatment; secondary end points included confirmed complete response rate and total body residence time. Results: Twenty-six patients were enrolled, and 25 were included in the intent-to-treat population. The overall unconfirmed response rate was 84%, and the confirmed complete response rate was 44%. The median progression free-survival was 27.6 months. The median total body residence time was 94.5 hours. No new or unexpected safety signals were identified. Conclusion: Patients with previously untreated MCL who received radioimmunotherapy with TST/I-131 TST followed by CHOP had a high response rate and a long duration of response, indicating that radioimmunotherapy is a therapeutic option in this patient population. © 2019 This study demonstrated that the radiolabeled anti-CD20 monoclonal antibody therapy tositumomab and iodine-131 tositumomab followed by chemotherapy is a potential treatment for mantle-cell lymphoma. Fourteen of 25 patients with previously untreated mantle-cell lymphoma who received this treatment combination experienced complete response (CR), with a median CR duration of 31.8 months. No unexpected adverse events were observed. © 2019
Keywords: monoclonal antibody; radioimmunotherapy; chop; anti-cd20
Journal Title: Clinical Lymphoma, Myeloma and Leukemia
Volume: 20
Issue: 11
ISSN: 2152-2650
Publisher: Elsevier Inc.  
Date Published: 2020-11-01
Start Page: 749
End Page: 756.e1
Language: English
DOI: 10.1016/j.clml.2019.04.010
PUBMED: 32800518
PROVIDER: scopus
Notes: Article -- Export Date: 1 December 2020 -- Source: Scopus
Citation Impact
MSK Authors
  1. Ariela Noy
    281 Noy
  2. Andrew D Zelenetz
    648 Zelenetz
  3. Ivelise A Rijo
    18 Rijo