D. Sertić

The EUTOS population-based registry: incidence and clinical characteristics of 2904 CML patients in 20 European Countries

This population-based registry was designed to provide robust and updated information on the characteristics and the epidemiology of chronic myeloid leukemia (CML). All cases of newly diagnosed Philadelphia positive, BCR-ABL1+ CML that occurred in a sample of 92.5 million adults living in 20 European countries, were registered over a median period of 39 months. 94.3% of the 2904 CML patients were diagnosed in chronic phase (CP). Median age was 56 years. 55.5% of patients had comorbidities, mainly cardiovascular (41.9%). High-risk patients were 24.7% by Sokal, 10.8% by EURO, and 11.8% by EUTOS risk scores. The raw incidence increased with age from 0.39/100 000/year in people 20–29 years old to 1.52 in those >70 years old, and showed a maximum of 1.39 in Italy and a minimum of 0.69 in Poland (all countries together: 0.99). The proportion of Sokal and Euro score high-risk patients seen in many countries indicates that trial patients were not a positive selection. Thus from a clinical point of view the results of most trials can be generalized to most countries. The incidences observed among European countries did not differ substantially. The estimated number of new CML cases per year in Europe is about 6370.

Treatment and outcome of 2904 CML patients from the EUTOS population-based registry

The European Treatment and Outcome Study (EUTOS) population-based registry includes data of all adult patients newly diagnosed with Philadelphia chromosome-positive and/or BCR-ABL1+ chronic myeloid leukemia (CML) in 20 predefined countries and regions of Europe. Registration time ranged from 12 to 60 months between January 2008 and December 2013. Median age was 55 years and median observation time was 29 months. Eighty percent of patients were treated first line with imatinib, and 17% with a second-generation tyrosine kinase inhibitor, mostly according to European LeukemiaNet recommendations. After 12 months, complete cytogenetic remission (CCyR) and major molecular response (MMR) were achieved in 57% and 41% of patients, respectively. Patients with high EUTOS risk scores achieved CCyR and MMR significantly later than patients with low EUTOS risk. Probabilities of overall survival (OS) and progression-free survival for all patients at 12, 24 and 30 months was 97%, 94% and 92%, and 95%, 92% and 90%, respectively. The new EUTOS long-term survival score was validated: the OS of patients differed significantly between the three risk groups. The probability of dying in remission was 1% after 24 months. The current management of patients with tyrosine kinase inhibitors resulted in responses and outcomes in the range reported from clinical trials. These data from a large population-based, patient sample provide a solid benchmark for the evaluation of new treatment policies.

P092 Acute myelomonocytic leukemia after HSCT with reduced intensity conditioning for CLL: a case report

Secondary acute leukemia is recognised long term complication after hematopoieticstem cell transplantation for chronic lymphocytic leukemia. Here we report a patient who developed acute myeloid leukemia one month after allogeneic HSCT with reduced conditioning regimen.

P015 Outcome in a small series of biphenotypic acute leukemia (BAL) patients

Background: Less than 5% of all cases of acute leukemia are classified as biphenotypic acute leukemia (BAL). Being a distinct entity recognized by the WHO classification, BAL is immunophenotypically defined by the European Group for the Immunological Classification of Leukemia (EGIL) scoring system, whereas according to FAB classification BAL may present as one of the ALL or AML subtypes. Since BAL is both a rare form of acute leukemia and shows diverse biological features, there is no consensus on the best treatment approach in these patients. Aim: Our aim was to analyze the laboratory characteristics and the outcome of patients diagnosed with BAL. Patients and methods: Using the EGIL system, we identified 21 cases (4%) of BAL from 535 newly diagnosed acute leukemia patients in the Zagreb Clinical Hospital Center in the period from end 1994-2006. Results: There were 16 male and 5 female patients with median age of 44 years (16- 74). Among them, there were 12 cases of B+myeloid leukemia (55%), 8 cases of T+myeloid (36%), 1 case of B+T lymphoid (5%) and 1 case of trilineage B+T+myeloid leukemia (5%). Morphologic assessment showed myeloid features in 9, lymphoid features in 6 and undifferentiated in 6 patients. Cytogenetic findings revealed normal as well as a wide range of aberrant karyotypes. The patients were treated according to the protocols for AML or ALL or with low-dose chemotherapy - 8, 10 and 3 patients, respectively. In the majority of patients overall survival was poor with a median of 7 months (1- 100) and with a probability of survival at two years of 35%. Conclusion: Despite the progress in the treatment of acute leukemia, the definition and the prognosis of BAL remains poor. Current treatment approach is heterogeneous and still based on cytomorphology. Treatment protocols designed specifically for this type of leukemia should be devised and studied in larger groups of patients.