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| |  Response to Lenalidomide Affected by Cytogenetic Factors in Patients With Myelodysplastic Syndromes: Presented at MDS 2011 By Jenny Powers EDINBURGH -- May 24, 2011 -- Overall survival following lenalidomide treatment is poorer in patients with myelodysplastic syndrome who have del(5q) + €2 chromosomal defects than it is in those with del(5q) + 1 or isolated del(5q) [iso-del(5q)] defects, according to study results presented here at the 11th International Symposium on Myelodysplastic Syndromes (MDS 2011). Similarly, patients with del(5q) + €2 defects had an increased risk of progression to acute myeloid leukaemia (AML) after treatment with lenalidomide. Aristoteles Giagounidis, MD, St. Johannes Hospital, Duisburg, Germany, spoke on behalf of colleagues here on May 19 about a study performed to determine the effect of cytogenetic abnormalities on overall survival and progression to AML in patients with low-risk MDS who were treated with lenalidomide. This study enrolled 274 lenalidomide-treated patients with baseline cytogenetic data, and stratified them according to cytogenetic abnormality into iso-del(5q), del(5q) + 1, or del(5q) + €2 groups. Overall survival and AML progression were calculated by Kaplan Meier from time of study entry or randomisation according to cytogenetic complexity. Baseline variables and red-blood-cell transfusion independence (RBC-TI) of 26 weeks or more were assessed in univariate models predicting AML progression; significant factors were then included in a multivariate proportional hazard model. In all, iso-del(5q) defects were found in 200 patients (73.0%); 50 patients (18.2%) had del(5q) + 1 defects, and 24 patients (8.8%) had del(5q) + €2 defects. The overall median interval from diagnosis was 2.7 years (range: 0.1-29.2 years). The median transfusion burden in all patients was 6 units per 8 weeks (range: 1-25 units). Following lenalidomide treatment, the median overall survival times were 19.4, 53.4, and 47.5 months, respectively, in patients with del(5q) + €2, del(5q) + 1, and iso-del(5q). Overall survival was shown to differ by cytogenetic risk group (log rank P =.0016) over time. Similar overall survival was observed in all cytogenetic groups in the first year of lenalidomide treatment. Additionally, del(5q) + €2 was associated with an increased likelihood of AML progression, but AML risk was similar in the iso-del(5q) and del(5q) + 1 groups. RBC-TI for 26 weeks or more was the only significant covariate that was associated with reduced AML risk (hazard ratio [HR] 0.587; P =.040), whereas in a multivariate analysis, only cytogenetic complexity had independent significance for AML progression (HR 1.942; P =.0014). Karyotype complexity is a critical determinant of overall survival, the researchers concluded, as is AML progression following lenalidomide treatment, with del(5q) + €2 being an indicator for AML progression in patients with MDS. [Presentation title: Interaction of Karyotype Complexity and Response on Overall Survival and AML Progression in Lenalidomide-Treated Low/INT-1 Risk del (5q) MDS Patients. Abstract 406]
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