Observacional Study for Evaluation of Quality of Life in Patients with Chronic Myeloid Leukemia (CML) in Use of Gleevec® (Imatinib Mesilate).

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.