Posters / Leukemia Research 35 (2011) S27–S142 S63 160 Validation of a disease-specific quality of life questionnaire (QoL-E) for patients with myelodysplastic syndromes (MDS) in Germany S. von Mackensen 1 , U. Germing 2 , K. G¨ otze 3 , A. Giagounidis 4 , E. Oliva 5 . 1 University Medical Centre Hamburg-Eppendorf, Institute for Medical Psychology, Hamburg, 2 Clinic of Haematology, Oncology and Clinical Immunology, Heinrich-Heine-University, D¨ usseldorf, 3 Haematology and Internal Oncology, Technical University Munich, Munich, 4 Medical Clinic 2, St.-Johannes Hospital Duisburg, Duisburg, Germany; 5 Haematology Department, Bianchi-Melacrino-Morelli Hospital, Reggio Calabria, Italy Introduction: Patients with myelodysplastic syndromes (MDS) must face the reality of a relatively low survival while depending on supportive and/or experimental therapy. Anemia and transfusion- dependence have been associated with poor quality of life (QoL). The efficacy of any therapeutic approach to alleviate symptoms due to cytopenias must be evaluated by patient-reported outcomes. Specific tools for the assessment of QoL are necessary and must undergo appropriate linguistic validation. QOL-E v. 2 is a self- administered questionnaire developed for the evaluation of QoL in patients with MDS (Oliva et al., 2002, 2008). It explores four general dimensions (physical, functional, social, sexual), a nearly- specific (fatigue) and a specific disease-related dimension of QOL. Scores are standardized on a scale from 0 to 100, where higher scores reflect better QOL. It has been validated in Italian, Bulgarian and USA English. In the present study, the German translation is being assessed in an epidemiological survey in 100 consecutive MDS patients in 3 German centers. Aims: To linguistically validate the QOL-E, to evaluate the psychometric characteristics and stability of the QOL-E tool in Germany, and to identify disease-related disturbances and their associations with disease-specific factors in German MDS patients. Methods: The validated QoL-E was translated into German according to EORTC guidelines (2 independent forward translations, 1 reconciliation, 1 backward translation). The quality of the translation was tested in German MDS patients regarding its comprehensibility and the possibility to make suggestions for reformulation of unclear items. MDS patients ≥18 years of age with primary or secondary MDS with at least one form of cytopenia according to IPSS criteria, willing and able to complete the questionnaire were included. QoL-E v2 was completed by patients before the clinical visit and a retest was performed after 1 month. Psychometric characteristics in terms of reliability (Cronbach’s alpha) and validity were performed. Results: The German translation was comprehensible, patients had only a problem with the meaning of the examples given for the item “performing heavy activities” (‘running’, ‘jumping”) which were reformulated. Psychometric characteristics of the QoL-E were good to satisfactory. Associations of QoL scores with blood counts and transfusion-dependence will be reported, controlling for known factors, such as age, co-morbidities, disease duration and prognostic risk. Conclusion: QOL-E v. 2 is the only instrument available for disease- specific evaluation of QoL in MDS. Its linguistic validation may identify QoL-E as a new tool for the evaluation of QoL in the German MDS population. 161 Azacytidine 75 mg/m 2 ×5 day in high-risk myelodysplastic syndromes and acute myeloid leukemia refractory/relapsed patients: Results from a single centre J. Bergua, M.J. Arcos Carmona, J. Prieto Fernandez, C. Cabrera Silva, F. Carnicero, H. Fernandez-Leyva, M.L. Bengochea Miranda, M.L. Mart´ ın-Mateos, F. Izquierdo, E. Gil Esparraga, N. Bermejo Vega, M.J. Garc´ ıa Blanco. Servicio de Hematolog´ ıa y Hemoterapia, Hospital San Pedro de Alc´ antara, Caceres, Spain Purpose: To analyze the results of administration Azacytine (75 mg/m 2 × 5 days) in patients with high risk myelodysplastic syndrome (HRMDS) and acute myeloid leukaemia refractory/ relapsed (AML) on an outpatient basis. Each cycle was performed every 28 days at a dose of 75 mg/m 2 X 5 days. Patients and Schedule: 31 patients diagnosed of HRMDS or AML (September 2007-September 2010). HRMDS was defined when IPSS was equal or higher than 1.5. AML patients were treated in this trial when they were refractory to conventional therapy, secondary AML or not fit to conventional therapy. Hydrea or thioguanine was permitted to control leukocyte counts. Response criteria were evaluated each cycle and at 6 th cycle by blood count and bone marrow aspiration (defined by IWG 2006). Non-responders patients were withdrawn of the treatment. In cases of bone marrow response but cytopenia, the courses were delayed after the sixth cycle. Results: The median age of the 31 patients was 73.8 year (35–87). (Male/Women: 25/6). WHO categories were: AREB-1: 3; AREB-2: 3; RCMD: 3; MDS-U: 2; LMM-2: 3; AML refactory or relapsed: 8; AML secondary to MDS: 10. 10 patients have secondary AML or SMD (1: after aplastic anemia; 1: prostate carcinoma treated with radio- therapy; 1: Hodgkin disease and autologous stem cell transplanta- tion; 1: mastocytosis plus chronic lymphocytic leukema; 1: chronic neutropenia; 1: rectal carcinoma; 1: acute promyelocytic leukemia). Cytogenetic risk: good: 14 patients; intermediate: 6 patients, high risk: 10 (31%). IPS: intermediate-2: 17 patients (54.83%); high risk: 14 (46.27%). The median time to treatment was 5, 133 months (0.91– 19.4). Bone marrow aspiration at the end of 6 th cycle was performed only in 13 patients (10 because early death; 7 because have not reach 6 th cycle; in one patient was not performed). Response to treatment and survival: Bone marrow CR +PR at 6 months was 12 (38.7%) (CR: 9; PR: 3). Transfusion independence, platelet and neutrophil responses were obtained in 12 patients. Median cycle to obtain response was the third cycles (1 st –7 th ). No differences in response were obtained between MDS and AML. Median survival of all the patients was 13.677. The median survival of AML group was 13.233 months; the median survival of MDS was 15.33 (p < 0.0251) (the same or better than reported by Itzykson, MDS French group. Two AML patients obtained complete response). This trial was not comparative, but 5 days schedule seems as effective as 7 days treatment in very unfavourable prognostic patients. 162 A phase II study of decitabine in advanced chronic myelomonocytic leukemia (CMML) T. Braun, N. Droin, R. Itzykson, B. de Renzis, F. Dreyfus, K. Laribi, K. Boabdallah, A. Charbonnier, C. Cordonnier, I. Lafon, C. Recher, N. Vey, J.-N. Bastie, A. Besan ¸ con, O. Beyne-Rauzy, B. Joly, E. Jourdan, L. Legros, Z. Marjanovic, C. Petitdidier, B. Royer, L. Sanhes, G. Tertian, I. Vaida, X. Vallantin, A. Vekhoff, M. Milic, C. Gardin, L. Ades, P. Fenaux, E. Solary. Groupe Francophone des Myelodysplasies (GFM), Bobigny, France Background: Prognosis of CMML is heterogeneous depending on both “MDS factors” (% marrow blasts, cytopenias, karyotype) and “MPN” factors, ie splenomegaly (SMG), WBC count, extramedullary disease (EMD). Treatment of advanced CMML is difficult. The hypomethylating agents azacitidine and decitabine (DAC) have shown efficacy in CMML, but in prognostically heterogeneous cohorts. We conducted a phase II trial of DAC in a well defined cohort of advanced CMML.