Objetives: Analyze the prognostic significance of CD38 expression compared to other prognostic factors.

Patients and methods: We studied retrospectively and prospectively at our institution 160 patients (pts) with diagnostic of CLL who met the diagnostic criteria of National Cancer Institute-Working Group (NCI-WG), 97 men and 63 female with an age range of 33 – 90 years (median 62) diagnosed between January 1989 and December 2003 and evaluated up to June 2004. Sixty nine pts showed CD38 positive cells and 91 were CD38 negative. CD38 expression was determined by flow cytometry defining as a higher expression > 7% CD38 positive cells. (

Krober A et al.
Blood
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1410
–1416.
2002
). Event Free Survival (EFS) and Overall Survival (OS) were analized according to different characteristics at diagnosis.

No. Patients%EFS 72 mop=%OS 72 mop=
Binet Stage A /B-C 129/31 65/30 0.000 90/92 0.245 
Rai Stage 0 /I – II – III – IV 92/68 72/37 0.000 94/94 0.339 
TDLI < / ≥ 12 mo 23/126 41/63 0.007 65/100 0.001 
Light Chains kappa / lambda 94/66 68/50 0.473 90/95 0.702 
CD38 Positive / Negative 69/91 32/82 0.000 81/100 0.000 
No. Patients%EFS 72 mop=%OS 72 mop=
Binet Stage A /B-C 129/31 65/30 0.000 90/92 0.245 
Rai Stage 0 /I – II – III – IV 92/68 72/37 0.000 94/94 0.339 
TDLI < / ≥ 12 mo 23/126 41/63 0.007 65/100 0.001 
Light Chains kappa / lambda 94/66 68/50 0.473 90/95 0.702 
CD38 Positive / Negative 69/91 32/82 0.000 81/100 0.000 

Statistical significant difference was observed in Binet stage, Rai stage, TDLI and CD38 expression for EFS and in TDLI and CD38 expression for OS. Considering these variables with p value of <0,05, a multivariable analysis was performed (Cox) in order to asses the adverse effect of each dichotomize group in EFS.

BetaS.E.H.R.95% C.I.p
CD38 Positive (1) /CD38 Negative(0) 1.70 0.32 5.5 2.89–10.53 0.000 
Binet B-C /Binet A(0) (1) 1.46 0.29 4.33 2.42–7.7 0.000 
RAI I-II-III-IV /RAI 0 (0) (1) 1.45 0.30 4.29 2.37–7.78 0.000 
TDLI ≥ 12 (1) /TDLI<12 (0) 0.03 0.00 1.03 1.01–1.04 0.000 
BetaS.E.H.R.95% C.I.p
CD38 Positive (1) /CD38 Negative(0) 1.70 0.32 5.5 2.89–10.53 0.000 
Binet B-C /Binet A(0) (1) 1.46 0.29 4.33 2.42–7.7 0.000 
RAI I-II-III-IV /RAI 0 (0) (1) 1.45 0.30 4.29 2.37–7.78 0.000 
TDLI ≥ 12 (1) /TDLI<12 (0) 0.03 0.00 1.03 1.01–1.04 0.000 

This analysis shows that the presence of CD38 positive cells at diagnosis conferred an adverse effect on EFS with a HR 5.5 (95% confidence interval 2.89–10.53) over the other variables included.

Conclusion:In our population, patients with CD38 positive expression showed a EFS and OS at 72 months of 32% and 82% ( p=0.000) versus 81% and 100% (p=0.000) in patients with CD38 negative expression. We can conlude that CD38 positive cells will identify a subgroup of patients with aggresive clinical outcome and worse prognosis.

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