Dacogen™ Effective in Myelodysplastic Syndromes

Dacogen™ Effective in Myelodysplastic Syndromes

According to results presented at the 46th annual meeting of the American Society of Hematology (ASH), the agent Dacogen (decitabine) appears to provide promising anti-cancer activity in the treatment of myelodysplastic syndromes (MDS).

MDS is a disease in which the cells in a persons bone marrow are not functioning normally. The bone marrow (and circulating blood) contains early blood-forming cells called stem cells, which grow and mature into the 3 blood cell types: white blood cells, which protect the body from infection; red blood cells, which carry oxygen to the tissues; and platelets, which help the blood to clot. In the case of MDS, not enough normal blood cells are being produced and/or the blood cells die prematurely. This condition is sometimes referred to as a pre-leukemia or smoldering leukemia because it often develops into acute myeloid leukemia (AML), an aggressive type of cancer. Some patients with MDS also have additional abnormalities, including genetic abnormalities of the blood cells, a high number of immature blood cells (called blasts) in the bone marrow, or decreasing numbers of red blood cells, white blood cells, or platelets. These individuals are at a higher risk for a more rapid progression to leukemia than are those who have more favorable cell features. There are five different stages, or extent, of MDS that include (in order of disease progression) refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transition, and chronic myelomonocytic leukemia.

Standard treatment for MDS can include a range of therapies, from observation and supportive care to an aggressive stem cell transplant, depending upon the extent or aggressiveness of the disease, as well as the medical condition and age of the patient. There are several agents in clinical trials in the evaluation of treatment for MDS. Dacogen is an agent that disrupts cellular processes so that cancer cells stop growing. Dacogen is currently in the last phase of clinical trials prior to FDA review.

Researchers from the MD Anderson Cancer Center recently conducted a clinical trial that is the last phase prior to FDA review. Patients in this trial had been diagnosed with MDS and were treated with either Dacogen plus supportive care or supportive care alone and all patients were then directly compared. Anti-cancer responses occurred in 17% of patients treated with Dacogen, with an average response duration of 266 days. Conversely, no patients treated with supportive care only achieved a disappearance of cancer. The average duration of time to cancer progression or death was 340 days for those treated with Dacogen, compared to 219 days for those treated with supportive care only. All patients who achieved a response to Dacogen had improvement in health status, fatigue levels, ability to breathe, and overall quality of life.

The researchers concluded that Dacogen was an effective agent in the treatment of MDS. Patients with MDS may wish to speak with their physician regarding the risks and benefits of participating in a clinical trial further evaluating Dacogen. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (cancer.gov) and www.cancerconsultants.com.

Reference: Issa J-P, et al. First Report of the Phase III North American Trial of Decitabine in Advanced Myelodysplastic Syndrome (MDS). Proceedings from the 2004 annual meeting of the American Society of Hematology. Presented Sunday, December 5, 2004, 4:30 PM. Abstract Number: 67

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