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Breakthrough For Leukemia

Posted: 10:50 am EST December 21, 2006

BACKGROUND: More than 10,000 people in the United States will be diagnosed with chronic lymphocytic leukemia (CLL) this year. More than 4,600 people will die from the disease. CLL only affects adults and is rarely seen in people under age 40. The average age at diagnosis is 70.

According to the American Cancer Society, CLL starts in lymphocytes -- the white blood cells -- of the bone marrow and then invades the blood. It can spread to lymph nodes, the spleen, liver, and other parts of the body. Doctors believe there are two different kinds of CLL. One is slow-growing while the other is a faster growing and more serious disease. The slow growing type rarely needs to even be treated. The average survival for patients with this type of CLL is between 13 and 15 years. The faster growing type of CLL leaves patients with an average survival of only about six to eight years. Treatments for CLL can include chemotherapy, monoclonal antibodies, surgery, radiation and/or bone marrow or peripheral blood stem cell transplantation.

RECURRENCE: Asher Chanan-Khan, M.D., from the Roswell Park Cancer Institute in Buffalo, says, “The sad part of this disease is that going into treatment, we know that patients will be relapsing and that the majority of patients will not achieve complete remission.” He says patients with CLL will be in remission for about one to three years and then the cancer will return. He says every time it comes back, it becomes more aggressive: “There is a time that there is almost nothing you can do about it and there is only so much that the body can take in terms of chemotherapy. Since there are only two or three approved treatments for these patients … most of the patients, after they’ve gone through the second or the third round of treatment, they do not have any options left.”

NOW, A NEW OPTION: Now, doctors have something more to offer patients. A new drug called lenalidomide is making waves in the field of CLL. The drug is a spin-off of the drug thalidomide. Thalidomide is a drug that was used in the 60s for nausea among pregnant women. It was banned due to the side effects, one of which was birth defects in babies. However, in the last decade, researchers have found that thalidomide has a very strong anti-cancer effect. But the risk of side effects like birth defects, nerve toxicity, sedation and fatigue make it a tough drug to handle -- even though it’s effective at killing cancer cells. (Today, thalidomide is a standard treatment for multiple myeloma). Researchers began developing drugs that work like thalidomide but without the side effects. The result? Lenalidomide. Not only is this newer version safer than thalidomide, it’s far more potent against cancer cells. Dr. Chanan-Khan says, “It makes the environment of the cancer cells very unfavorable for its survival ... With the first dose, patients started to respond. They would start to have signs suggestive of an immune wakening.”

CLINICAL PROOF: A recent study tested lenalidomide in 19 patients with CLL who were resistant to chemotherapy. Thirteen of those patients had a significant clinical response. Dr. Chanan-Khan says, “In the blood, we could start seeing their leukemia counts coming down very fast. Even within seven days, we saw significant decrease in the leukemia counts, up to 90 percent in some patients.” Some patients have even gone into complete remission, virtually unheard of at that point in the disease. Dr. Chanan-Khan says, “We have several patients now, in whom we cannot detect cancer anymore by the most sophisticated test that we can employ.” The drug is already FDA-approved to treat multiple myeloma and is currently under study for CLL as well as non-Hodgkin’s lymphoma. Below are links to some trials on lenalidomide:

(TRIALS NO LONGER RECRUITING PATIENTS)
http://www.clinicaltrials.gov/ct/show/NCT00267059 (CLL)
http://www.clinicaltrials.gov/ct/show/NCT00096044 (CLL)
http://www.clinicaltrials.gov/ct/show/NCT00238238 (non-Hodgkin’s lymphoma)
http://www.clinicaltrials.gov/ct/show/NCT00322985 (non-Hodgkin’s lymphoma)