Early Lenalidomide Intervention Delays Transfusion Dependency Onset in MDS

In patients who have low- or intermediate-risk myelodysplastic syndromes (MDS) with chromosome 5q deletion—del(5q)—and non-transfusion dependent anemia, early intervention with lenalidomide is a viable means of delaying progression to transfusion dependency. This was one of the key findings from the SintraREV clinical trial recently reported in The Lancet Haematology.

“Lenalidomide is the standard of care for patients who are transfusion dependent with [del(5q)] MDS,” explained trial lead author María Díez-Campelo, MD, PhD, of the University Hospital of Salamanca in Spain.

SintraREV was a multinational, randomized, double-blind, phase III trial conducted at 22 university hospitals. Its cohort included 61 adult patients, was 82% female, and had a median patient age of 72.2 years. A total of 38 patients received lenalidomide 5 mg daily in 28-day cycles for two years and 21 received placebo. Median follow-up was 60.6 months.

Median time to patient transfusion dependency, the primary endpoint of the study, was not reached by the patients who received lenalidomide and was 11.6 months for patients in the placebo group (P=.0027). Researchers calculated that lenalidomide reduced risk of transfusion dependency by 69.8% (hazard ratio, 0.302; P=.0046).

Regarding treatment-related adverse events, the most frequent was neutropenia, which occurred in 63% of patients in the lenalidomide group and 19% in the placebo group.

In the lenalidomide group, thrombocytopenia occurred in 18% of patients. The most common nonhematological toxicity was skin disorder, which manifested as rash in 23% of patients and had grade 3 severity in 3%.

Nineteen serious adverse events were reported in 13 patients, and five of the events were possibly related to the study drug. A total of 18 events occurred in the lenalidomide group and one occurred in the placebo group. There were no mortalities associated with treatment in the trial.

“An early approach with low doses of lenalidomide across two years delays the time to transfusion dependency and improves the rate and quality of the responses, with a manageable safety profile in patients who are non-transfusion dependent with del(5q) low-risk MDS,” Dr. Díez-Campelo concluded.

The SintraREV trial was funded by Bristol Myers Squibb.

Reference

Díez-Campelo M, López-Cadenas F, Xicoy B, et al. Low dose lenalidomide versus placebo in non-transfusion dependent patients with low risk, del(5q) myelodysplastic syndromes (SintraREV): a randomised, double-blind, phase 3 trial. Lancet Haematol. 2024. doi:10.1016/S2352-3026(24)00142-X