Lenalidomide does not increase AML progression risk in RBC transfusion-dependent patients with Low- or...

Area of Science:

• Hematology
• Oncology
• Clinical Trials

Background:

• Limited data exists on long-term outcomes for lenalidomide-treated versus untreated patients with myelodysplastic syndromes (MDS) and the del(5q) chromosomal abnormality.
• Patients with del(5q) MDS often require red blood cell (RBC) transfusions, impacting their prognosis.

Purpose of the Study:

• To compare long-term clinical outcomes, including acute myeloid leukemia (AML) progression and overall survival (OS), between lenalidomide-treated and untreated patients with del(5q) Low- or Intermediate-1 (Int-1)-risk MDS.
• To assess risk factors for AML progression and mortality in these patient populations.

Main Methods:

• Retrospective analysis of 295 lenalidomide-treated patients from trials MDS-003 and MDS-004.
• Comparison with 125 untreated RBC transfusion-dependent patients with del(5q) Low- or Int-1-risk MDS from a multicenter registry.
• Cox proportional hazards models with left truncation were used to adjust for cohort differences.

Main Results:

• Median follow-up was over 4 years for both cohorts.
• Two-year cumulative AML progression incidence was 6.9% for lenalidomide-treated and 12.1% for untreated patients.
• Two-year overall survival probabilities were 89.9% for lenalidomide-treated and 74.4% for untreated patients.
• AML progression risk was similar between groups (HR 0.969, P=0.930).
• Lenalidomide treatment significantly improved survival (HR 0.597, P=0.012) after adjusting for covariates.

Conclusions:

• Lenalidomide treatment does not elevate the risk of AML progression in RBC transfusion-dependent patients with del(5q) Low- or Int-1-risk MDS.
• Lenalidomide therapy appears to confer a survival advantage in this patient cohort.