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Blood, 1 July 2001, Vol. 98, No. 1, pp. 41-48
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Prognostic factors and response to fludarabine therapy in
patients with Waldenström macroglobulinemia: results of United
States intergroup trial (Southwest Oncology Group
S9003)
Madhav V. Dhodapkar,
Joth
L. Jacobson,
Morie A. Gertz,
Saul E. Rivkin,
G. David Roodman,
Joseph M. Tuscano,
Muhammad Shurafa,
Robert A. Kyle,
John J. Crowley, and
Bart Barlogie
From the Laboratory of Cellular Physiology and
Immunology, Rockefeller University, New York, NY; Southwest Oncology
Group Statistical Center, Seattle, WA; Mayo Clinic, Rochester, MN;
Puget Sound Oncology Consortium, Seattle, WA; University of Texas
Health Science Center at San Antonio; University of California, Davis,
Sacramento; Henry Ford Hospital, Detroit, MI; and University of
Arkansas for Medical Science, Little Rock.
Current information on Waldenström macroglobulinemia (WM) is
based on retrospective or single-institution studies of patients requiring therapy. Between 1992 and 1998, 231 patients with WM were
enrolled in a prospective observational multicenter clinical trial. Of
these, 182 patients with symptomatic or progressive disease were
treated with 4 to 8 cycles of therapy with a purine nucleoside
analogue, fludarabine (FAMP; 30 mg/m2 of body-surface area
daily for 5 days every 28 days). A serum  2-microglobulin (2M)
level below 3 mg/L and a hemoglobin level of at least 120 g/L (12 g/dL) at presentation predicted a lower likelihood of requiring
therapy. The overall rate of response to FAMP therapy was 36% (95%
confidence interval, 29%-44%), with 2% complete remissions. Patients
who were 70 years old or older had a substantially lower likelihood of
response (odds ratio, 0.34; P = .004) than younger
patients. On multivariate analysis, a serum 2M level of 3 mg/L or
higher, hemoglobin level below 120 g/L, and serum IgM level below 40 g/L [4 g/dL] were significant adverse prognostic factors for
survival. We developed a simple staging system for WM by using these
variables and identified 4 distinct subsets of patients with estimated
5-year overall survival rates of 87%, 64%, 53%, and 22%, and 5-year
progression-free survival rates of 83%, 55%, 33%, and 12%.
Prognosis in WM is highly variable and serum 2M was the dominant
predictor of a need for therapy and of survival. FAMP has activity
against WM. Our staging system may provide guidance for a risk-based
approach to the treatment of WM.
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