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Blood, 30 April 2009, Vol. 113, No. 18, pp. 4188-4196.
Prepublished online as a Blood First Edition Paper on November 17, 2008; DOI 10.1182/blood-2008-09-176149.


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CLINICAL TRIALS AND OBSERVATIONS

B-cell count and survival: differentiating chronic lymphocytic leukemia from monoclonal B-cell lymphocytosis based on clinical outcome

Tait D. Shanafelt1, Neil E. Kay1, Greg Jenkins1, Timothy G. Call1, Clive S. Zent1, Diane F. Jelinek1, William G. Morice1, Justin Boysen1, Liam Zakko1, Susan Schwager1, Susan L. Slager1, and Curtis A. Hanson1

1 Mayo Clinic, Rochester, MN

The diagnosis of chronic lymphocytic leukemia (CLL) in asymptomatic patients has historically been based on documenting a characteristic lymphocyte clone and the presence of lymphocytosis. There are minimal data regarding which lymphocyte parameter (absolute lymphocyte count [ALC] or B-cell count) and what threshold should be used for diagnosis. We analyzed the relationship of ALC and B-cell count with clinical outcome in 459 patients with a clonal population of CLL phenotype to determine (1) whether the CLL diagnosis should be based on ALC or B-cell count, (2) what lymphocyte threshold should be used for diagnosis, and (3) whether any lymphocyte count has independent prognostic value after accounting for biologic/molecular prognostic markers. B-cell count and ALC had similar value for predicting treatment-free survival (TFS) and overall survival as continuous variables, but as binary factors, a B-cell threshold of 11 x 109/L best predicted survival. B-cell count remained an independent predictor of TFS after controlling for ZAP-70, IGHV, CD38, or fluorescence in situ hybridization (FISH) results (all P < .001). These analyses support basing the diagnosis of CLL on B-cell count and retaining the size of the B-cell count in the diagnostic criteria. Using clinically relevant criteria to distinguish between monoclonal B-cell lymphocytosis (MBL) and CLL could minimize patient distress caused by labeling asymptomatic people at low risk for adverse clinical consequences as having CLL.


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