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Recommended Revlimid Starting Dose Is More Effective Than Low-Dose Revlimid For Myelodysplastic Syndromes (ASH 2009)

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Published: Dec 23, 2009 4:07 pm
Recommended Revlimid Starting Dose Is More Effective Than Low-Dose Revlimid For Myelodysplastic Syndromes (ASH 2009)

Revlimid (lenalidomide) given at a dose of 10 mg may be the most effective initial dose for the treatment of myelodysplastic syndromes (MDS), according to the results of a Phase 3 study conducted by a team of international researchers. The findings were presented at the 51st Annual American Society of Hematology (ASH) meeting and exposition on December 8.

For 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. The recommended starting dose for MDS patients is 10 mg Revlimid daily, but the dose is lowered if patients experience severe side effects during treatment.

This study investigated the efficacy and safety of a low dose Revlimid regimen (5 mg daily) as compared to the recommended 10 mg dosing.

The study included 138 patients with transfusion-dependent low- or intermediate-1 risk MDS and del-5q. Patients were randomized to receive 5 mg Revlimid on days 1 through 28, 10 mg Revlimid on days 1 through 21, or a placebo, all on a 28-day cycle. Response was assessed at 16 weeks, and responders continued treatment for up to 52 weeks.

Patients in the 5 mg Revlimid group and the placebo group who did not respond by week 16 were considered treatment failures and were given Revlimid at 10 mg or 5 mg, respectively, in an extension phase in which patients knew which treatment they were receiving. Patients who completed 52 weeks of treatment could also enter the open phase at their current dosage level.

Of the three groups, the 10 mg Revlimid group achieved the highest response rate of 41 percent. The 5 mg Revlimid group achieved a response rate of 17 percent, while the placebo group did not achieve any response.

The Revlimid groups also had a significantly higher rate of transfusion independence compared to the placebo group. Fifty-six percent of patients in the 10 mg Revlimid group no longer required blood transfusions as well as 41 percent of the 5 mg Revlimid group. Among the placebo group, 6 percent of patients achieved transfusion independence.

The most common side effects were severe neutropenia (low white blood cell count) and severe thrombocytopenia (low platelet count). Neutropenia was reported in 75 percent of the 10 mg Revlimid group, 74 percent of the 5 mg Revlimid group, and 15 percent of the placebo group. Thrombocytopenia was reported in 41 percent of the 10 mg Revlimid group, 33 percent of the 5 mg Revlimid group, and 2 percent of the placebo group.

Discontinuation of treatment due to adverse events within the first 52 weeks occurred in 16 percent of the 5 mg Revlimid group, 9 percent of the 10 mg Revlimid group, and 5 percent of the placebo group.

Researchers concluded that 10 mg was the ideal initial treatment dose of Revlimid, with dose reductions or discontinuation as needed. However, researchers also stated that Revlimid at both 10 mg and 5 mg was generally well-tolerated and achieved significant transfusion independence in transfusion-dependent low- or intermediate-1 risk MDS patients with the del-5q chromosomal abnormality.

For more information, see abstract 944 at the ASH Meeting Web site.

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2 Comments »

  • KELLY said:

    I am a pharmacist looking for additional drug information on revlimid dosing regimens if a patient is receiving radiation.
    thanks

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    Julie Shilane said:

    Kelly, I called Revlimid’s Medical Information hotline to ask about your question. As you may already be aware, the Revlimid prescribing information (pdf) does not mention a dose reduction or change relating to radiation. Therefore, I was told that Celgene’s recommendations for a patient undergoing radiation are no different than for other patients.

    I also did a literature search, but did not come across any directly relevant studies. There is one study about concurrent radiation therapy and Revlimid treatment, but it is for myeloma patients. Unfortunately, the study is not publicly available.