Welcome to Managing MDS. Hi, I am Dr. Stuart Goldberg. I would like to briefly review with you predictors of response to lenalidomide in a non-del(5q) MDS patient. In the last 10 years, we have all known that in patients with transfusion‑dependent, low-grade disease who harbor an abnormality of del(5q), lenalidomide (an oral agent), can result in 2/3 of these patients becoming transfusion-independent within only two to three months. But what about the patient who does not have a 5q abnormality? Can we use lenalidomide in these transfusion-dependent low-grade patients? The answer is coming from some clinical trials.
The MDS-005 trial, which was reported by Dr. Santini in the Journal of Clinical Oncology, randomized patients who had failed erythropoietin or were intolerant of erythropoietin, who had low-grade disease and were transfusion-dependent who did not have a 5q. What they noticed was that about 29% of patients would have a response, become transfusion-independent, or develop clinical benefit from the lenalidomide. The doses were 10 mg daily, or 5 mg daily in those patients who had thrombocytopenia and – something new – those patients who also had renal insufficiency. In the study, it was found that in general, the medication was well-tolerated, with cytopenias being the main reason that patients came off trial.
Something else that was important to note, and was reported at this year's American Society of Hematology Meeting, was that keeping patients on treatment increased the ability to have a response. For those patients who are developing a cytopenia such as neutropenia or thrombocytopenia, rather than just stopping the medication and moving on, if you lower the dose from 10 mg to 5 mg, or if you started spreading out the dose – missing days here and cutting dose – those patients who remained on therapy derived additional benefit. We now can look at a patient who is non-5q and think that about 29% to 30% of them may respond in the red cells, if we keep them on lower-dose lenalidomide for a longer period of time. It may give us a new option before we move on to demethylating agents.
Thank you for listening.
Santini V, et al. J Clin Oncol. 2016; 34:2988-2996.