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Purpose: Imatinib Mesilate is currently considered the most advanced therapy for CML due to its innovative molecular targeting mechanism of action, resulting in a high level of efficacy with a favorable toxicity profile which results in health-related quality of life (HRQL) benefits. We therefore decided to evaluate 230 patients with chronic myeloid leukemia (CML) treated with Imatinib Mesilate (Gleevec) as second line therapy, along 12 months, after failing Interferon (IFN) based therapy, due to lack of efficacy or toxicity, in an a Quality of Life (QoL) Study in Brazil, here presented as an interim analysis. Patients and Methods: From July 2002 until December 2003, 230 Patients from 21 Brazilian Medical Institutions, were enrolled in a Quality of Life (QoL) Study, where patients completed FACT-BRM questionnaire at baseline and during treatment. FACT-BRM includes 4 subscales appropriate for any chronic illness or treatment [physical (PWB), social/family (SFWB), emotional (EWB), functional (FWB)] and 2 treatment-specific subscales [BRM-physical (BRMP). The primary endpoint was the composite Trial Outcomes Index (TOI=PWB + FWB +BRMP + BRMCE). The questionnaire was applied at baseline (visit 0),monthly thereafter during the first 6 months on imatinib therapy (visits 1 through 7) and finally after 12 months on treatment (visit 8). Study population was distributed as following: gender 55,9% male and 44,1% female, mean age 46 years (range 18 to 76), Karnofsky status 100% in 56.7% and 80–90% in 29.9%. Initial Imatinib Mesilate dose was 400mg for 81,3% and 600mg for 18,7%. All patients were evaluated at baseline and at visits 7 (six months) and 8 (12 months) 147 (63.9%) and 45 (19.5%) patients were evaluated, respectively. Results: An increase of 5 or more from baseline was defined as a clinically relevant improvement 6. Patients had clinically relevant mean estimated improvement in TOI along treatment. After 1 treatment month TOI had an estimated mean increase of 5.4 (p<0.0001), after 6 months 7.4 (p<0.0001) and after 12 treatment months 9.8 (p<0.0051). TOTAL score improved significantly along treatment, with a clinically relevant mean estimated improvement of 6.5 (p<0.0001) already present after 1 treatment month. Improvement was equal to 8.0 (p=0.0007) and 10.7 (p=0.0369) after 6 and 12 treatment months. There were, also, significant increases in patients’ mean estimated FACTG (p<0.0001), BRMPHY (p<0.0001) and PWB (p<0.0001) along treatment. Conclusion: Imatinib offers remarkable QoL improvement even as a second line treatment in CML as reported previously on IRIS Study, where patients were allowed to cross over to the Imatinib treatment arm, after receiving Interferon based therapy.

Background: B-cell chronic lymphocytic leukemia (B-CLL) is characterized by the progressive accumulation of a neoplastic clone consisting of CD5/CD19/CD23/surface immunoglobulin cells. Despite this homogeneity in phenotype, B-CLL can follow either an indolent or a progressive course. CD38 is a transmembrane glycoprotein expressed on the surface of leukemic cells in a significant percentage of patients with B-CLL. Recent studies suggest that CD38 expression in CLL is a reliable prognostic marker, leading to an unfavorable clinical course with a more advanced stage of disease, poor responsiveness to chemotherapy and a shorter survival rate, along with others markers like ZAP-70 that reflect more accurately the mutagenic status of VH gene region, unfortunately not yet available in clinical practice routinely. Objectives: To assess the association of CD38+ expression with clinical and laboratory parameters at diagnosis in patients with B-CLL. Patients and Methods: CD38 expression was analyzed in 64 unselected newly diagnosed B-CLL patients from January 2003 to May 2005 seen at the Hematology Center of Pernambuco-Brazil (HEMOPE). According to Damle et al. patients with 30% or more B cells expressing CD38 were considered positive(CD38+), and those with less than 30% were considered negative(CD38−). Various patient characteristics were studied including age, sex, Binet stage, hemoglobin, ß2 microglobulin and lactate dehydrogenase levels in the serum. Statistical differences between each group (CD38+ vs CD38−) were analyzed using χ2 tests for categorical variables and Student’s t-tests for continuous variables. Results: Thirty-six patients (56.25%) were CD38+ and 28 (43.75%) were CD38-. Their median age at diagnosis was 64 years (range, 39–83) and the male to female ratio was 1.46:1. There were no differences between age, sex, hemoglobin and ß2 microglobulin levels in the CD38+ and CD38- groups. ß2 microglobulin level, however, was not available for assessment in all patients. Lactate dehydrogenase level was significantly higher in the CD38+ group (p=0.007). It was observed a trend toward a higher Binet stage (B or C) in the CD38+ compared with CD38- group (63.4 vs. 36.6% respectively), although not statistically significant (p=0.09) possibly because of the small number of patients studied. Conclusion: CD38 expression was associated with a higher lactate dehydrogenase level and a tendency for more aggressive clinical stage. CD38 evaluation is a measurable biological parameter that is not as subjective as the evaluation of some clinical parameters and should be considered a stantard clinical test for newly diagnosed B-CLL patients.

The occurrence of leukemia during pregnancy is very rare with an estimated incidence of one per 100,000 pregnancies annually. It has been estimated that during pregnancy most leukemias are acute: two thirds are myeloid (AML) and one third are lymphoid (ALL). Chronic myeloid leukemia (CML) is found in less than 10% of leukemias during pregnancy and chronic lymphocytic leukemia (CLL) is extremely rare. The management of CML during pregnancy is a difficult problem because of the potential effects of the therapy on the mother and fetus. Since the disease has an initial chronic phase, it is usually managed conservatively during pregnancy, while an aggressive approach, such as bone marrow transplantation, may be considered after delivery. A limited number of cases described successful treatment modalities of CML during pregnancy including leukapheresis, hydroxyurea (HU) and interferon (IFN). We report nine cases of pregnancy in seven chronic myeloid leukemia patients, giving birth healthy children in a single institution from 1979 to 2005. In four cases the diagnosis of CML was made on prebirth period in routine blood testing, and five pregnancies developed during the course of disease. Four of the pregnancies were found in the first trimester, four in the second and one in the third. Median age of patients was 21 years (range 18–30years). All patients were Ph1 positive and the leucocyte count ranged between 45 to 336 x 109 /L. Table 1 shows treatment performed in patients before and during pregnancy. Patients 4 and 7 had a subsequent pregnancy despite the use of contraceptive methods, both diagnosed in the first trimester. Hydroxyurea was stopped during pregnancy. Delivery was performed by caesarean section in 5 cases and by spontaneous vaginal delivery in 4 cases. All infants’ examination and blood counts were normal and there were no perinatal or maternal complications. In june 2005, two new cases of pregnant CML patients were seen at our institution. One of them was being treated with imatinib, and the other without treatment at the moment of pregnancy. They will be managed only with leukapheresis. Our data suggest that exposure to IFN and HU during pregnancy is probably not associated with a significantly increased risk for malformations, however leukapheresis can be considered for treatment of CML during pregnancy because of the lack of teratogenic and other adverse effects in patients who tolerate and respond to the procedure. Cases Age (years) CML diagnosis Pregnancy diagnosis Trimester of pregnancy Treatment before pregnancy Treatment during pregnancy 1 18 Sep/1993 Oct/1993 First None HU 2 30 Dec/1996 Jan/1997 Third None Leukapheresis 3 18 Dec/1993 Nov/1995 First IFN stopped IFN 4 21 Sep/1995 Sep/1995 Second None HU 5 21 Jul/1994 Aug/1994 Second HU stopped HU 6 27 Jan/1979 Jan/1979 Second None Busulphan - 2 months 7 18 Dec/1995 Oct/1996 Second HU HU