MDS

Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin

Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin

In the March 20, 2021 edition of Journal of Clinical Oncology, Alan F. List and colleagues report on the results of lenalidomide-epoetin alfa versus lenalidomide monotherapy in EPO refractory MDS.

PURPOSE

In the reported clinical trial, investigators assessed treatment with lenalidomide (L), plus epoetin alpha (E) in patients with lower-risk, non-5q deleted MDS with either EPO-refractory anemia or those with a low likelihood of response.

METHODS

A phase 3 clinical trial was developed, where patients underwent stratification by serum erythropoietin concentration and prior erythropoietin treatment.

RESULTS

195 patients were randomized: 99 patients to the LE cohort and 96 to L monotherapy cohort. After 4 cycles of treatment, the primary end point of major erythroid response (MER) was notably higher (28.3%) with LE vs L alone (11.5%) (P = .004). 136 patients completed 16 weeks of study treatment, 38.9% and 15.6% achieved MER, respectively (P = .004). Additionally, a minor erythroid response was achieved in 18.2% and 20.8% of patients, for an overall erythroid response rate of 46.5% versus 32.3%. Among L nonresponders, 38 crossed over to the addition of E with 10 patients (26.3%) achieving a MER. Responses to LE were durable with a median MER duration of 23.8 months compared with 13 months with L monotherapy.

The authors concluded “LEN restores sensitivity to recombinant erythropoietin in growth factor–insensitive, lower-risk, non-del(5q) MDS, to yield a significantly higher rate and duration of MER compared with LEN alone.”

https://ascopubs.org/doi/full/10.1200/JCO.20.01691

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