THE EUTOS POPULATION-BASED REGISTRY: EVALUATION OF BASELINE CHARACTERISTICS AND FIRST TREATMENT CHOICES OF 2983 NEWLY DIAGNOSED CHRONIC MYELOID LEUKEMIA (CML) PATIENTS FROM 20 EUROPEAN COUNTRIES

ABSSUB-5170

Background: Most of the knowledge about treatments and outcome of CML patients originates from clinical studies. To get new and unbiased insights in the epidemiology, treatment and outcome of CML, the EUTOS population-based registry of newly diagnosed CML patients was established, - as part of the European Treatment and Outcome Study (EUTOS) for CML.

Aims: The aim was to collect the data of all adults with newly diagnosed CML, irrespective of treatment and of enrolment in studies.

Methods: The EUTOS population-based registry collected data of newly diagnosed CML patients, 18 years or older, over a specified period of time from 2008 till 2012 living in defined regions. The data were collected by 22 study groups in 20 European countries. Data were gathered via a web-based CRF-system.

Results: Till 31.12.2013 2983 patients were registered. Treatment data are currently available for 1948 patients. 94.2% of the patients were diagnosed in chronic phase (CP), 3.6% in accelerated phase (AP), and 2.2% in blastic phase (BP). 54% of the patients were male. The median age at diagnosis was 57 (range: 18-99) years, varying from 50 yrs. in Russia to 62 in Sweden. Stratified by decades, 0.6% patients were 18 or 19 years old, 6.8% 20-29 years, 11.6% 30-39 years, 16.8% 40-49 years, 22.1% 50-59 years, 19.2% 60-69 years, 16.0% 70-79 years, 6.4% 80-89 years, and 0.5% more than 90 years old. According to the WHO PS score, in CP 57.4% of patients were asymptomatic, 36.6% were symptomatic but completely ambulatory, 4.2% were symptomatic but less than 50% in bed during the day, 1.2% were symptomatic with more than 50% in bed during the day, and 0.6 % were bedbound. For patients in AP or BP at onset, the corresponding figures were 31.9%, 41.3%, 18.1%, 7.2%, and 1.4%. For 55.4% of the patients comorbidities were recorded. 18.4% of patients were current smokers, while 16.6% were former smokers, and 65.0% were non-smokers.  For the calculation of the prognostic scores 432 patients had to be excluded as they had already been treated before measuring the hematologic values. By EUTOS Score (Hasford et al., 2011) 88.7% of CP patients were low risk, and 11.3% were high risk. By Euro Score 37.8% were low, 51.4% intermediate and 10.9% high. By Sokal Score 34.5% were low, 40.8% intermediate, and 24.8% high. CP patient distribution by spleen volume, blood cell count, and differential are shown in Table 1. 83.3% of the patients received imatinib firstline, 10.9% nilotinib and 3.8% dasatinib. During the first year after diagnosis, 9.4% of patients received nilotinib and 6.0% dasatinib second-line.

Table 1:

*palpated, cm under costal margin

Summary/Conclusion: This is the first report of the demographic and baseline characteristics of an unselected, population-based, series of patients with newly diagnosed Ph+, BCR-ABL+ CML. The age distribution and some baseline characteristics are different from many prospective studies. This should be taken in due consideration before extrapolating the results of treatment studies to the overall population. With further follow-up, this registry will provide a population-based insight on treatment, survival, and causes of death.

Keywords: Chronic myeloid leukemia, Treatment

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