Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study.
Bottom Line: In a 6-month landmark analysis, overall survival was longer in lenalidomide-treated patients with RBC-TI ≥182 d vs. non-responders (P = 0.0072).The most common grade 3-4 adverse event was myelosuppression.These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion-dependent patients with IPSS-defined Low-/Int-1-risk MDS with isolated del(5q).
Affiliation: Marien Hospital Düsseldorf, Düsseldorf, Germany.Show MeSH
Related in: MedlinePlus
Mentions: Progression to AML by randomised treatment group is presented in Fig.2A. The estimated 2–year cumulative risk of progression to AML was 12.6% (95%CI: 5.4–27.7), 17.4% (95%CI: 8.7–33.3) and 16.7% (95%CI: 8.3–32.0) in the lenalidomide 10 mg, lenalidomide 5 mg and placebo groups, respectively. The estimated 4-yr cumulative risk of progression to AML was 30.6% (95%CI: 18.1–48.8), 35.4% (95%CI: 21.4–54.6) and 43.3% (95%CI: 27.6–63.1) in the lenalidomide 10 mg, lenalidomide 5 mg and placebo groups, respectively. Of the seven patients randomised to placebo, who did not cross over to receive lenalidomide 5 mg in the open-label extension phase, 3 (42.9%) progressed to AML.