TY - JOUR
T1 - A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia
AU - Nand, Sucha
AU - Othus, Megan
AU - Godwin, John E.
AU - Willman, Cheryl L.
AU - Norwood, Thomas H.
AU - Howard, Dianna S.
AU - Coutre, Steven E.
AU - Erba, Harry P.
AU - Appelbaum, Frederick R.
PY - 2013/11/14
Y1 - 2013/11/14
N2 - This trial tested the safety and efficacy of a regimen consisting of hydroxyurea followed by azacitidine, 75 mg/m2 for 7 days, and gemtuzumab ozogamicin, 3 mg/m2 on day 8, in older patients with newly diagnosed acute myeloid leukemia. Those achieving a complete remission received 1 consolidation treatment followed by 4 cycles of azacitidine. The patients were stratified into good-risk (age 60-69 years or performance status 0-1) and poor-risk (age ≥70 years and performance status 2 or 3) groups. Specific efficacy and safety goals were defined as being supportive of further study of the regimen. Eightythree patients were registered in the good-risk cohort and 59 in poor-risk cohort, with median age of 71 and 75 years, respectively. In the good-risk group, 35 patients (44%) achieved a complete remission. Median relapse-free and overall survivals were 8 and 11 months, respectively. Six patients (8%) died within 30 days of registration. In the poor-risk group, 19 (35%) achieved a complete remission. Median relapse-free and overall survivals were 7 and 11 months, respectively. Seven patients (14%) died early. The results of this trial met predefined goals for efficacy and safety for the poor-risk cohort but not the good-risk group. This trial was registered at www.clinicaltrials.gov as #NCT00658814.
AB - This trial tested the safety and efficacy of a regimen consisting of hydroxyurea followed by azacitidine, 75 mg/m2 for 7 days, and gemtuzumab ozogamicin, 3 mg/m2 on day 8, in older patients with newly diagnosed acute myeloid leukemia. Those achieving a complete remission received 1 consolidation treatment followed by 4 cycles of azacitidine. The patients were stratified into good-risk (age 60-69 years or performance status 0-1) and poor-risk (age ≥70 years and performance status 2 or 3) groups. Specific efficacy and safety goals were defined as being supportive of further study of the regimen. Eightythree patients were registered in the good-risk cohort and 59 in poor-risk cohort, with median age of 71 and 75 years, respectively. In the good-risk group, 35 patients (44%) achieved a complete remission. Median relapse-free and overall survivals were 8 and 11 months, respectively. Six patients (8%) died within 30 days of registration. In the poor-risk group, 19 (35%) achieved a complete remission. Median relapse-free and overall survivals were 7 and 11 months, respectively. Seven patients (14%) died early. The results of this trial met predefined goals for efficacy and safety for the poor-risk cohort but not the good-risk group. This trial was registered at www.clinicaltrials.gov as #NCT00658814.
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U2 - 10.1182/blood-2013-06-506592
DO - 10.1182/blood-2013-06-506592
M3 - Article
C2 - 24092933
AN - SCOPUS:84888252567
SN - 0006-4971
VL - 122
SP - 3432
EP - 3439
JO - Blood
JF - Blood
IS - 20
ER -