Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Diagnosis of primary or secondary myelodysplastic syndromes (MDS)
• •* Any FAB or WHO criteria cellular type allowed
• •Bone marrow blast count on aspiration or biopsy of 1 of the following:
• •* No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities)
• •* 11-20%
• •* 21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e., refractory anemia with excess blasts in transformation by FAB classification)
• •* Patients who failed the cytogenetic exam are allowed provided bone marrow blasts are at least 5% and/or 2-3 cytopenias are present
• •No rapid progression towards full-blown AML
• •No blast crisis of chronic myeloid leukemia
• •No t(8;21) alone or in combination with other abnormalities
• •Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline)
• •PATIENT CHARACTERISTICS:
• •Age
• •60 and over
• •Performance status
• •WHO 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •See Disease Characteristics
• •Hepatic
• •Bilirubin less than 1.5 times upper limit of normal (ULN)
• •Hepatitis B surface antigen negative
• •Renal
• •Creatinine less than 1.5 times ULN
• •Cardiovascular
• •No severe cardiovascular disease
• •No arrhythmias requiring chronic treatment
• •No congestive heart failure
• •No New York Heart Association class III or IV heart disease
• •No symptomatic ischemic heart disease
• •Other
• •HIV negative
• •No active uncontrolled infection
• •No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the past 2 years
• •No prior or concurrent evidence of CNS or psychiatric disorders requiring hospitalization
• •No psychological, familial, sociological, or geographical condition that would preclude study
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •More than 6 weeks since prior growth factors for primary MDS
• •No concurrent antiangiogenic drugs (e.g., thalidomide)
• •No concurrent interleukin, interferon, or anti-thymocyte globulin
• •Chemotherapy
• •See Disease Characteristics
• •More than 6 weeks since prior hydroxyurea for primary MDS
• •No other prior chemotherapy for MDS or AML
• •Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed
• •Endocrine therapy
• •No concurrent steroids (except as inhalation therapy)
• •Radiotherapy
• •Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed
• •Surgery
• •Not specified
• •Other
• •More than 6 weeks since prior immunosuppressive agents for primary MDS
• •No concurrent amifostine
• •No concurrent cyclosporine
• •No other concurrent experimental therapies