CLINICAL RESPONSES

A controlled phase III study with DACOGEN^® (decitabine) for Injection included a total of 170 adult patients with myelodysplastic syndromes (MDS). The results showed DACOGEN plus supportive care was effective^2,3 and response rates were superior to those of supportive care alone (Table 2).^2,3 DACOGEN overall improvement rates (complete, partial, hematologic) were based on rigorous International Working Group MDS (2000) response criteria.^2,3,15

• p<0.001 for pairwise difference (from two-sided Fisher's exact test) between DACOGEN plus supportive vs supportive care alone. No complete or partial responses were achieved with supportive care.
^† A randomized, open-label, multicenter controlled trial. Patients in the DACOGEN plus supportive care arm received an intravenous infusion of 15 mg/m² over 3 hours, every 8 hours, for 3 consecutive days. This cycle was repeated every 6 weeks, depending upon the patient’s clinical response and toxicity. Supportive care consisted of blood and blood product transfusions, prophylactic antibiotics, and hematopoietic growth factors.
^‡ Patients received a median of 3 cycles of treatment.
^¥ Median time to acute myelogenous leukemia or death of 49 weeks vs 31 weeks with supportive care (p = 0.160 [NS]).^2,3

References