Certain patients with MDS receiving Revlimid demonstrated a manageable safety profile.
Patients with non-transfusion dependent myelodysplastic syndromes (MDS) who were treated with low doses of Revlimid (lenalidomide) across two years experienced a delay in the time to blood transfusion dependency, researchers have found.
Revlimid is an oral treatment that is used to treat patients with anemia (low levels of red blood cells) and patients with a certain type of MDS. Specifically, patients with MDS who experience anemia and are dependent on blood transfusions may benefit most from the treatment, according to the Mayo Clinic.
In the phase 3 SintraRev study published in The Lancet Hematology, researchers found that treatment with low doses of Revlimid throughout the span of two years may slow the time to transfusion dependence, improve the rate and quality of treatment responses and demonstrate a manageable safety profile for patients with chromosome 5q deletion MDS who are non-transfusion dependent.
A total of 61 patients were randomly assigned to two groups: the Revlimid group (40 patients) or the placebo group (inactive drug; 21 patients). The median time to treatment was 66 weeks, with approximately 95.9 weeks in patients from the Revlimid group and approximately 42.7 months in patients from the placebo group, according to the study.
Of note, 19 of 40 patients from the Revlimid group successfully completed treatment compared with seven of 21 patients from the placebo group, researchers noted. Early discontinuation was caused by disease progression (worsening or spreading) in eight of 19 patients in the Revlimid group and 10 of 14 patients in the placebo group.
“[Revlimid] reduced the time of transfusion dependence,” the researchers wrote. “Delaying transfusion dependence aims to improve quality of life and avoid relevant complications related to transfusion dependence, including potentially decreasing the risk of acute myeloid leukemia progression and even improving overall survival.”
Among the total patients in the study, 43 of 61 had low-risk MDS and 18 patients had intermediate-1-risk MDS. There were 54 total patients who had chromosome 5q deletions, researchers established.
At a median follow-up of 60.6 months in the intent-to-treat population, 23 patients developed blood transfusion dependence. Ten and 13 patients from the Revlimid and placebo groups, respectively, developed transfusion dependence, as stated in the study.
Specifically, treatment with Revlimid reduced the risk of blood transfusion dependency by 69.8%. The median time to transfusion dependence from the time of treatment was longer in patients who received Revlimid compared with patients in the placebo group. In particular, the median time to transfusion dependence was not reached in the Revlimid group (meaning more than half of patients were not transfusion dependent upon the time of assessment) compared with 11.6 months in the placebo group.
Time to transfusion dependence from diagnosis was also measured in the patient population, according to the study. Patients from the Revlimid group demonstrated more favorable outcomes regarding time to transfusion dependence from diagnosis because the median time was not reached. This means patients treated with Revlimid had a longer time until blood transfusion dependence than estimated by researchers. Compared with the Revlimid group, for which median time to transfusion dependence was not reached, patients in the placebo group had a median time of 25.9 months to transfusion dependence from diagnosis.
The safety of Revlimid was also reviewed by researchers during the trial in 59 patients. They established that 40 of 59 patients developed at least one side effect that was potentially related to treatment. The most frequent treatment-related side effect that was reported was neutropenia (lower levels of white blood cell counts), which occurred in 24 of 38 patients from the Revlimid group and four of 21 patients in the placebo group.
Reference
“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” by María Díez-Campelo, et al., The Lancet Haematology.
The second most common side effect was thrombocytopenia (abnormally low levels of platelets in the blood), researchers stated. This occurred in seven patients from the Revlimid group and none of the patients from the placebo group. Of note, there were no reported treatment-related deaths in either treatment group, researchers stated.
“[Revlimid] was well tolerated, with a manageable safety profile and no increased rates of acute myeloid leukemia progression,” the researchers wrote. “These findings support the efficacy of low-dose [Revlimid] in patients who are not transfusion dependent, for whom early treatment of anemia could be crucial to improve disease outcomes.”
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