According to results from an early online publication in the journal Cancer, Dacogen™ (decitabine) improves outcomes compared with supportive care only in the treatment of myelodysplastic syndromes.
Myelodysplastic syndromes are a group of blood (hematologic) disorders that are diagnosed in 10,000–20,000 individuals annually in the US. MDS occurs when immature blood cells do not mature properly and are not able to perform their intended function. They instead crowd out normal blood cells in the bone marrow, often inhibiting other cells from performing their intended functions.
MDS can also develop into an aggressive form of leukemia, acute myelogenous leukemia (AML). Preventing or delaying MDS from developing into AML is an important consideration since long-term survival of AML is not favorable.
Standard treatment for MDS can include therapies ranging from observation and supportive care to an aggressive stem cell transplant. Choice of therapies depends on the extent or aggressiveness of the disease as well as the patient’s medical condition and age. Vidaza® and Revlimid® are new agents that have recently been approved for the treatment of MDS; clinical trials evaluating various agents for the treatment of MDS are ongoing.
Decitabine is an agent that is not yet approved by the FDA; however, the FDA plans a review of decitabine in May of 2006. Decitabine provides anticancer activity by disrupting cellular processes so that cancer cells stop growing.
Researchers from the MD Anderson Cancer Center recently conducted a phase III clinical trial directly comparing decitabine to supportive care in the treatment of patients with MDS.
This trial included 170 patients with MDS; 21% of whom had received prior therapy. Patients were treated with either decitabine or supportive care consisting of red blood cell transfusions, platelet transfusions, and/or agents to stimulate the growth of red blood cells when necessary.
Decitabine improved outcomes compared to best supportive care:
- Overall anticancer responses were achieved in 17% of patients treated with decitabine, compared with 0% in patients treated with supportive care.
- Hematologic (blood) improvement occurred in 12% of patients treated with decitabine, compared with 7% of patients treated with supportive care.
- Anticancer responses lasted for a median of 10.3 months.
- The median duration of time to the development of AML or death was 12.1 months for patients treated with decitabine versus 7.8 months for those treated with supportive care.
- Patients with intermediate or high-risk MDS (higher risk of disease progression) and those with MDS that was not associated with treatment from a previous cancer obtained the greatest benefit.
- Survival was improved among patients who achieved responses to decitabine compared to patients who did not respond to decitabine (23.5 months versus 13.7 months, respectively).
- Quality of life was reported as greater among patients treated with decitabine versus those treated with supportive care measures.
- Severe neutropenia (low levels of immune cells) and thrombocytopenia (low levels of platelets) were common side effects of decitabine.
The researchers concluded that decitabine appears to help delay the progression of MDS to AML, provides long-lasting anticancer responses, and improves quality of life among patients with MDS.
Reference: Kantarjian H, Isaa J-P, Rosenfeld C, et al. Decitabine improves patient outcomes in myelodysplastic syndromes. Cancer. 2006. Early on-line publication. DOI: 10.1002/cncr 21796.
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