Epidemiological Study and Prognostic Markers in Patients Diagnosed with Chronic Ly Lmphocytic Leukemia. EPIGEN Study.

CLL represent 30% of leukemias diagnosed in Europe (incidence rate: 0.9-2.4 case/year/100.000 inhabitants). When only consider subjects over 70, the incidence rate is higher. The onset age and associated comorbidities are the main factors that limiting the therapy and prognosis in symptomatic patients. Genetic aberrations and immunophenotype biomarkers, are new tools to predict progression and response to therapy with Fludarabine.

To determine annual incidence, demographic characteristics and comorbidities associated to CLL patients in a Northern Spanish area (4,686,175 inh).

A prospective, descriptive and analytical study performed during 1st September 2007 to 31 August 2008, 13 hospitals are participating, collecting clinical and biological characteristics at diagnosis: demography, staging, cell counts, CD38, ZAP70, genetic aberrations and IgVH gene mutation. In addition we obtain RNA in every case to study the gene profiling by expression microarray. The study has been approved by the CEICA and all patients signed informed consent for the study. The variables were included in a SPSS database data. Descriptive statistics, frequency analysis, incidence rate and rate comorbidities has been calculated.

We have collected data from 96 patients (incidence rate: 2.04 × 105/y), considering only patients over 60 the IR was 15.9 × 105/y. The preliminary analysis included 89 patients: M /F 49 (55%) / 40 (45%). Mean age: 69.7 years (41-91) M: 69.0 years and F: 70.5 years. (>70 years: 54%). Staging (Rai and Binet): A/0 66.3%, A/I 13.5%, A/II 2.2% B/I 3.4%, B/II 9%, B/III 2.2%, C/III 1,1%, C/IV 2.2%. 10.8% started with splenomegaly. At diagnosis 34.1% had lymph node involvement and 4.5% extranodal disease. Immunophenotype biomarkers: CD38 + 24.7%, ZAP70 + 19.7%. Genetic aberrations: del 13q: 21.3%, 12 trisomy: 13.5%, del 11p: 4.5%, del 17p: 1.1%, normal: 52.8%. Molecular: Ig VH gene mutation 19.1%.Comorbidities: cardiac impairment 65%, autoimmune disorders 14%, concomitant infections 9%, other primary tumour: 12.3%, other 7%. 33.7% had 2 or more comorbidities and 50% had one.

1) Demographic data were similar to previous data in the Aragon community, although probably the incidence is underestimated. In spite of males has higher incidence, the age at diagnosis is superior in women. 2) Frequently Stages: A0, AI. 3) The most frequent genetic aberrations: del13 and 12 trisomy. 4) The global incidence of comorbidities is high. 5) A subsequent analysis will assess: association of genetic profiles with clinical characteristics and associated comorbidities is pendant. This study is partially supported by a grant from FEHHA

No relevant conflicts of interest to declare.