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Revlimid Alternate-Day Dosing Regimen Shows Promise In Myelodysplastic Syndromes

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Published: Nov 24, 2009 5:45 pm
Revlimid Alternate-Day Dosing Regimen Shows Promise In Myelodysplastic Syndromes

A new report by Italian researchers suggests that Revlimid (lenalidomide), administered to myelodysplastic syndromes (MDS) patients on alternate days, may offer comparable efficacy to the standard daily dosing regimen, but with reduced side effects and treatment costs.

In MDS, Revlimid is typically used as a treatment for Low- or Intermediate-1 risk patients, especially those who require red blood cell transfusions and have del-5q.  A del-5q mutation is a chromosomal abnormality characterized by a missing ‘q’ arm of chromosome 5. 

Revlimid is intended to help MDS patients achieve red blood cell transfusion independence, and is usually given at a standard dose of 10 mg daily during the first 21 days in repeated 28-day cycles.

Recent data indicate that, at its standard dose and for its target patient population, Revlimid can achieve transfusion independence in more than 60 percent of patients.  However, many patients treated with Revlimid also experience drug-related side effects, such as temporarily lowered white blood cell levels (neutropenia) and lowered platelet levels (thrombocytopenia).  In addition, treatment with Revlimid can be expensive.

In the recent Italian study, six transfusion-dependent MDS patients received Revlimid every other day during the first 21 days in repeated 28-day cycles.  Researchers hoped an alternating-day schedule would lower drug-related side effects as well as the overall cost of the treatment, while still maintaining the same level of efficacy.

This was the first study to examine the efficacy and possibly lower side effects of an alternating-day schedule for Revlimid, according to the researchers.

All six patients in the Italian study became independent of red blood cell transfusions, with three patients achieving independence in three months, and the other three in four months.

In terms of drug-related side effects, two patients experienced significant neutropenia, a rate of 33 percent, and one patient experienced significant thrombocytopenia, a rate of 17 percent.  No patients experienced fever or infection.

In comparison, recent data suggest that Revlimid given on a daily schedule produces significant neutropenia in 55 percent of patients, and significant thrombocytopenia in 44 percent of patients.

“I think dose reduction alone is responsible for this lowered toxicity,” Dr. Defina Marzia of the University of Siena in Italy, one of the authors of the report, told the Beacon.

The alternating-day schedule also reduced the cost of the drug by 50 percent.

Previous attempts to reduce Revlimid’s side effects included lowering the daily dose from 10 mg to 5 mg. This did decrease side effects, but it did not substantially reduce the overall price of the drug.

Although all six patients in the Italian study achieved transfusion independence with the alternating-day schedule, achieving independence took longer than with the standard daily schedule. Dr. Marzia pointed out that patients on a daily Revlimid dosing regimen typically achieve transfusion independence in four to six weeks.

The authors also pointed out that, due to the small number of patients and the short follow-up length of less than 14 months, the new alternate-day schedule needs to be explored in a larger study. Results based on at least 15 to 20 additional patients will be needed to confirm the study results, said Dr. Marzia.

For more details, please see the report in the British Journal of Hematology (subscription required).

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