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Blood, 1 November 2005, Vol. 106, No. 9, pp. 2977-2981.
Prepublished online as a Blood First Edition Paper on July 14, 2005; DOI 10.1182/blood-2005-02-0691.
Previous Article | Next Article 
Submitted February 18, 2005
Accepted June 10, 2005
Clinical factors predictive of outcome with bortezomib in patients with relapsed, refractory multiple myeloma
Paul G Richardson*, Bart Barlogie, James Berenson, Seema Singhal, Sundar Jagannath, David Irwin, S. V Rajkumar, Teru Hideshima, Hugh Xiao, Dixie Esseltine, David Schenkein, and Kenneth C Anderson
Dana-Farber Cancer Institute, Boston, MA, USA
University of Arkansas for Medical Sciences, Littlerock, AR, USA
Cedars-Sinai Medical Center, Los Angeles, CA, USA
Northwestern Memorial Hospital, Chicago, IL, USA
St Vincent's Comprehensive Cancer Center, New York, NY, USA
Alta Bates Cancer Center, Berkeley, CA, USA
Mayo Clinic, Rochester, MN, USA
Millennium Pharmaceuticals, Inc., Cambridge, MA, USA
* Corresponding author; email: Paul_Richardson{at}DFCI.Harvard.edu.
Bortezomib, a potent and reversible proteasome inhibitor, affects the myeloma cell and its microenvironment, resulting in downregulation of growth and survival signaling pathways and durable responses in patients with relapsed and refractory myeloma. Potential associations between baseline parameters and outcomes with bortezomib were explored in 202 patients who received bortezomib 1.3 mg/m2 twice weekly for 2 weeks every 3 weeks for up to 8 cycles in a phase 2 trial. Using European Group for Blood and Marrow Transplantation criteria, the response rate (complete or partial response) to bortezomib alone was 27% and not associated with sex, race, performance status, isotype, chromosome 13 deletion, number or type of previous therapies, or concentration of hemoglobin or 2-microglobulin. By multivariate analysis, factors associated with lower response were age 65 versus < 65 years (19% vs 32%; P < .05) and > 50% versus 50% plasma cell infiltration in bone marrow (20% vs 35%; P < .05). Factors that may be indicative of tumor burden (bone marrow plasma cell infiltration > 50%, hypoalbuminemia, thrombocytopenia) were predictive of overall survival. Chromosome 13 deletion and elevated 2-microglobulin, generally considered poor prognostic factors, were not predictive of poor outcome with bortezomib in this study.

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