Multicenter clinical trial of bortezomib in relapsed/refractory Waldenstrom's macroglobulinemia: results of WMCTG Trial 03-248.

Abstract

PURPOSE:

Waldenstrom's macroglobulinemia (WM) is a B-cell disorder. Despite advances in the therapy, WM remains incurable. As such, novel therapeutic agents are needed for the treatment of WM.

EXPERIMENTAL DESIGN:

In this multicenter study, 27 patients with WM received up to eight cycles of bortezomib at 1.3 mg/m(2) on days 1, 4, 8, and 11. All but one patient had relapsed/or refractory disease.

RESULTS:

Following therapy, median serum IgM levels declined from 4,660 to 2,092 mg/dL (P < 0.0001). The overall response rate was 85%, with 10 and 13 patients achieving minor and major responses, respectively. Responses were prompt and occurred at median of 1.4 months. The median time to progression for all responding patients was 7.9 (range, 3-21.4+) months. The most common grade III/IV toxicities occurring in > or =5% of patients were sensory neuropathies (22.2%), leukopenia (18.5%), neutropenia (14.8%), dizziness (11.1%), and thrombocytopenia (7.4%). Sensory neuropathies resolved or improved in nearly all patients following cessation of therapy.

CONCLUSIONS:

The results of these studies show that bortezomib is an active agent in relapsed and refractory WM.

• Authors: Steven P Treon, Zachary R Hunter, Jeffrey Matous, Robin M Joyce, Brian Mannion, Ranjana Advani, David Cook, Joseph Songer, John Hill, Bruce R Kaden, David Sharon, Ronald Steiss, Xavier Leleu, Andrew R Branagan, Ashraf Badros
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 13 Issue 11 Pg. 3320-5 (Jun 01 2007) ISSN: 1078-0432 [Print] United States
• PMID: 17545538 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Boronic Acids
• Immunoglobulin M
• Pyrazines
• Bortezomib

Topics

• Adult
• Aged
• Antineoplastic Agents (therapeutic use)
• Bone Marrow (drug effects)
• Boronic Acids (therapeutic use)
• Bortezomib
• Clinical Trials as Topic
• Female
• Humans
• Immunoglobulin M (blood)
• Male
• Middle Aged
• Pyrazines (therapeutic use)
• Recurrence
• Time Factors
• Treatment Outcome
• Waldenstrom Macroglobulinemia (drug therapy)