Lenalidomide May Replace Blood Transfusions In Myelodysplastic Syndrome

ORLANDO, Florida (Reuters Health) - The anti-angiogenic drug lenalidomide continues to show "unprecedented hematologic and cytogenetic remitting activity" in patients with transfusion-dependent myelodysplastic syndrome (MDS), new data show. Some such patients treated with the drug can discontinue blood transfusions.

All the patients in the study had a 5q31 chromosomal deletion, which is the most common cytogenetic abnormality in MDS and is characterized by transfusion-dependent anemia, Dr. Alan F. List from the H. Lee Moffitt Cancer Center in Tampa, Florida explained at the annual meeting of the American Society of Clinical Oncology.

In a study published earlier this year in The New England Journal of Medicine, 10 of 12 MDS patients with the 5q31 deletion did "very well on lenalidomide," he reported. "They not only had a hematologic response but they also had a cytogenetic response." (See Reuters Health report Feb. 10, 2005)

These observations formed the basis of the current study, reported during a plenary session at ASCO.

While the current trial is ongoing, 6-month data show that 97 of 148 patients with MDS deletion 5q (66%) taking lenalidomide 10 mg/d achieved transfusion independence and a median hemoglobin increase of 5.3 g/dL.

The response to lenalidomide is "very durable," Dr. List said, noting that 71 of the 97 responders (73%) have remained transfusion independent after a median follow up of 58 weeks.

Eighty-one of 115 patients (70%) evaluated mounted a cytogenetic response. Fifty-one (44%) achieved a complete cytogenetic remission and 26% showed a minor cytogenetic response.

The most common side effects necessitating treatment interruption or dose reduction were neutropenia and thrombocytopenia, seen in 39% and 35% of study patients, respectively.

Collectively, the data show that lenalidomide is highly effective in MDS 5q deletion patients, Dr. List concluded, adding, "This is the first effective therapy for this specific subtype of disease."

The study was sponsored by Celegene Corporation, which recently submitted a new drug application for lenalidomide (RevLimid) to the US Food and Drug Administration.

MeSH Headings: Biological Therapy : Blood Transfusion : Growth Inhibitors : Therapeutics : Drugs, Investigational : Angiogenesis Inhibitors : Analytical, Diagnostic and Therapeutic Techniques and Equipment

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