Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials?

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Authors

ŽÁČKOVÁ Daniela KLAMOVÁ Hana DUŠEK Ladislav MUŽÍK Jan MACHOVÁ POLÁKOVÁ Kateřina MORAVCOVÁ Jana JURČEK Tomáš DVOŘÁKOVÁ Dana RÁČIL Zdeněk POSPÍŠIL Zdeněk OLTOVÁ Alexandra MICHALOVÁ Kyra BŘEZINOVÁ Jana RÁZGA Filip DOUBEK Michael CETKOVSKÝ Petr TRNĚNÝ Marek MAYER Jiří

Year of publication 2011
Type Article in Periodical
Magazine / Source American Journal of Hematology
MU Faculty or unit

Faculty of Medicine

Citation
Doi http://dx.doi.org/10.1002/ajh.21942
Field Oncology and hematology
Keywords Imatinib treatment; chronic phase; myeloid leukemia
Description Imatinib (IM) dramatically improved the prognosis of chronic myeloid leukemia (CML), particularly with newly diagnosed patients in a chronic phase (CP) [1]. The most robust source of data about IM efficacy in this setting is the IRIS trial. However, every day clinical practice data are still scarce. We analyzed IM efficacy and safety in the first-line therapy of 152 consecutive adult CP-CML patients from a defined region. The estimated 4-year cumulative incidences of complete hematologic, complete cytogenetic, major, and complete molecular responses were 95.3%, 80.6%, 65.4%, and 39.2%, respectively. The 4-year probability of overall and progression-free survival (PFS) defined as with the IRIS [2] was 91.5% and 78.1%, respectively. We thus confirmed very good IM efficacy also in patients not participating in clinical trials. However, the estimated 4-year event-free survival (EFS), which also counted failure events according to valid recommendations [3] or IM discontinuation due to intolerance, was only 60.7%. The 4-year probability of an alternative treatment-free survival, our newly defined parameter, which better reflects the proportion of patients remaining on IM despite an event, was 67.6%. Therefore, more appropriate selection and unification of survival analyses end-points is desirable to describe and compare IM real efficacy.

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