[PDF][PDF] Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B

LR Silverman, EP Demakos, BL Peterson… - Journal of Clinical …, 2002 - scholar.archive.org
LR Silverman, EP Demakos, BL Peterson, AB Kornblith, JC Holland, R Odchimar-Reissig…
Journal of Clinical oncology, 2002scholar.archive.org
Purpose: Patients with high-risk myelodysplastic syndrome (MDS) have high mortality from
bone marrow failure or transformation to acute leukemia. Supportive care is standard
therapy. We previously reported that azacitidine (Aza C) was active in patients with high-risk
MDS. Patients and Methods: A randomized controlled trial was undertaken in 191 patients
with MDS to compare Aza C (75 mg/m2/d subcutaneously for 7 days every 28 days) with
supportive care. MDS was defined by French-American-British criteria. New rigorous …
Purpose: Patients with high-risk myelodysplastic syndrome (MDS) have high mortality from bone marrow failure or transformation to acute leukemia. Supportive care is standard therapy. We previously reported that azacitidine (Aza C) was active in patients with high-risk MDS.
Patients and Methods: A randomized controlled trial was undertaken in 191 patients with MDS to compare Aza C (75 mg/m2/d subcutaneously for 7 days every 28 days) with supportive care. MDS was defined by French-American-British criteria. New rigorous response criteria were applied. Both arms received transfusions and antibiotics as required. Patients in the supportive care arm whose disease worsened were permitted to cross over to Aza C.
Results: Responses occurred in 60% of patients on the
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