SIGNIFICANCE OF ANEMIA IN PATIENTS WITH CML AT DIAGNOSIS AND DURING THE TREATMENT WITH IMATINIB OUTSIDE THE CLINICAL TRIALS: CAMELIA REGISTRY EXPERIENCE

Background
Attention of physicians caring for CML patients is seldom focused on anemia as it was not shown to be an independent prognostic factor and it may have different causes during the course of disease. The relevance of anemia in routine clinical setting outside the clinical trials has not been sufficiently covered. 

Aims
To evaluate the prognostic and clinical importance of anemia in CML patients treated with imatinib using data from the international CML CAMELIA Registry.  

Methods
Retrospective analysis of all files of CML patients treated with first-line imatinib in first chronic phase was performed. For the purpose of the study anemia was defined by hemoglobin level lower than 120g/l. Single center survey of quality of life using simple questionnaire in 32 CML patients with and 31 without anemia was performed. For statistical testing Mann-Whitney test and Fisher exact test, for survival analysis Kaplan-Meier method with log-rank test were used.

Results
Anemia was identified at diagnosis in 211 (45%) from the total cohort of 469 patients in first chronic phase of CML treated with imatinib. Anemia was not associated with initial cytogenetic findings (p = 0.946) or age (p=0.125), but strong correlation was found with higher risk scores in all prognostic systems (Sokal, Hasford, EUTOS; p<0.001). Patients with anemia had significantly higher numbers of WBC (median=175.6 vs 48.0 p<0.001) and more frequent splenomegaly (p<0.001). Response to the treatment was similar: major molecular response was achieved in 72.5% and 68.7% of patients without and with anemia, respectively. However, when assessing overall survival with the end-point death caused by CML, anemia was associated with worse outcome (log-rank test p=0.013). There were 23 deaths caused by CML among 31 dead patients with anemia (74.2%) but only 11 out of 28 deaths (39.3%) in the group of patients without anemia (p=0.009). During the treatment with imatinib anemia was identified in 91 (19.4%) patients at one or more occasions. There was no correlation with the anemia or risk scores at diagnosis. There was a trend towards association of anemia with age over 60 years (24.4% vs 16.9%; p=0.063). Anemia during the treatment was not associated with response to treatment, but has significant impact on quality of life: patients spent more time in bed (p=0.014), less time outside the flat or house (p<0.001), they suffered more from dyspnea (p=0.022) and there were trends for lower Karnofski score (p=0.057), unemployment (p=0.077) or sport capacity (p=0.079).  

Summary
Anemia at diagnosis in CML patients from CAMELIA Registry was a frequent finding and was associated with the high-risk features. Despite the fact that response to treatment was not compromised with anemia at diagnosis, a significant association was found with CML-related death rate. During the treatment with imatinib, anemia was found in about 20% of patients, affected more frequently elderly patients and had negative impact on their quality of life.

Keyword(s): Anemia, Chronic myeloid leukemia, Prognostic factor, Quality of life

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