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Revlimid May Help Against Chronic Leukemia

Summary: The drug Revlimid (lenalidomide) may be effective for some people with chronic lymphocytic leukemia (CLL) that has not responded to other treatments or comes back after treatment, according to a small Phase 2 study. If the results hold true in larger clinical trials, Revlimid may prove to be another option for patients who otherwise have few treatments left to try.

Why it's important: CLL is considered an incurable form of cancer. Although many people live for many years with this disease, it does eventually come back after treatment. There are not many treatments that work in this situation, especially if people have already been treated with the chemotherapy drug fludarabine. Patients need more effective ways to tackle CLL after their initial treatments.

What's already known: Revlimid was approved in 2005 to treat a type of bone marrow disorder called myelodysplastic syndrome. It has also shown promise against multiple myeloma, another type of bone marrow cancer. In lab studies, the drug appears to decrease the production of substances that help CLL cells survive, and to encourage the leukemia cells to die through a natural process called apoptosis. Those studies prompted the researchers, from the Roswell Park Cancer Institute in Buffalo, New York, to try Revlimid in patients with CLL. They published their findings in the Journal of Clinical Oncology.

How this study was done: The study included 45 people who had not responded to their CLL treatment or who had had a relapse after successful treatment. Most had been diagnosed with stage III or IV leukemia and were therefore considered high-risk patients. Participants took a Revlimid pill once a day. Treatment continued until the patients showed a response or had unacceptable side effects. Patients whose cancer progressed during treatment were given the drug Rituxan (rituximab) in addition to Revlimid.

What was found: Of the patients in whom a response could be measured, four (9%) had a complete response (no evidence of remaining disease) and 17 (38%) had a partial response to the Revlimid treatment. One patient died, and 3 saw their disease progress.

The Revlimid caused some side effects, including fatigue, low platelet counts, and low white cell counts. Two patients developed serious blood clots in the lungs. More than half of the participants in the study also experienced a flare reaction, which is a sudden swelling of the lymph nodes or spleen accompanied by fever and rash. This side effect was treated with ibuprofen. Patients who enrolled in the study later were given prednisone to make the flare reaction less severe if it did develop.

The bottom line: Although the researchers are concerned by the high percentage of side effects with the dose used in this study, they say Revlimid warrants further study in people with CLL. Future studies should explore different doses of Revlimid, and try combining Revlimid with other drugs that are effective against CLL (like Rituxan and the chemotherapy drug fludarabine), they say.