2017
DOI: 10.1200/jco.2016.67.6213
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Addition of Androgens Improves Survival in Elderly Patients With Acute Myeloid Leukemia: A GOELAMS Study

Abstract: Purpose Elderly patients with acute myeloid leukemia (AML) have a poor prognosis, and innovative maintenance therapy could improve their outcomes. Androgens, used in the treatment of aplastic anemia, have been reported to block proliferation of and initiate differentiation in AML cells. We report the results of a multicenter, phase III, randomized open-label trial exploring the benefit of adding androgens to maintenance therapy in patients 60 years of age or older. Patients and Methods A total of 330 patients … Show more

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Cited by 41 publications
(32 citation statements)
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“…107 A multicenter, phase III randomized study investigated the survival benefit of adding androgens to maintenance therapy in patients with AML aged ≥60 years (n=330). 108 In this study, induction therapy included cytarabine (100 mg/m 2 on days 1-7), idarubicin (8 mg/m 2 on days 1-5), and lomustine (200 mg/m 2 on day 1). Patients in CR or PR (n=247) were treated with 6 reinduction courses, alternating idarubicin on day 1, cytarabine on days 1 to 5, and a regimen of methotrexate and mercaptopurine, and randomized to receive androgen, norethandrolone (10 or 20 mg/d) according to body weight, or no norethandrolone for a 2-year maintenance therapy regimen.…”
Section: Postremission Therapymentioning
confidence: 99%
See 1 more Smart Citation
“…107 A multicenter, phase III randomized study investigated the survival benefit of adding androgens to maintenance therapy in patients with AML aged ≥60 years (n=330). 108 In this study, induction therapy included cytarabine (100 mg/m 2 on days 1-7), idarubicin (8 mg/m 2 on days 1-5), and lomustine (200 mg/m 2 on day 1). Patients in CR or PR (n=247) were treated with 6 reinduction courses, alternating idarubicin on day 1, cytarabine on days 1 to 5, and a regimen of methotrexate and mercaptopurine, and randomized to receive androgen, norethandrolone (10 or 20 mg/d) according to body weight, or no norethandrolone for a 2-year maintenance therapy regimen.…”
Section: Postremission Therapymentioning
confidence: 99%
“…Compared with the arm that received no androgens, norethandrolone improved rates of 5-year DFS (31.2% vs 16.2%, respectively), EFS (21.5% vs 12.9%, respectively), and OS (26.3% vs 17.2%, respectively). 108 For patients who previously received lower-intensity therapy, a marrow evaluation to document remission status on hematologic recovery should be performed after 8 to 12 weeks. If a response is observed, a clinical trial, reduced-intensity HCT, or continuation with hypomethylating regimens (every 4-6 weeks until progression) may be appropriate.…”
Section: Postremission Therapymentioning
confidence: 99%
“…Interestingly, the OS curve for norethandrolone only crossed into superior territory after~2.5 years. 44 Azacitidine has been evaluated in several phase 3 studies in the elderly patients with AML as a postremission maintenance therapy.…”
Section: Newer Flt3 Inhibitorsmentioning
confidence: 99%
“…15 Absence of benefit of decitabine maintenance in younger AML patients in CR over historical controls has also been recently reported. 13 An alternate schedule or association with other drugs might show a more favorable outcome (tested currently in NCT01041703 (decitabine after clofarabine) and NCT01757535 (oral azacytidine maintenance after daunorubicin-based induction)).…”
mentioning
confidence: 93%
“…15 ) including the same ICL induction but 2 years chemotherapy maintenance included 78 poor-risk cytogenetics patients, 9 with previous cancer but none with previous MDS, with a CR rate of 59%. Characteristics of these patients were similar to our population except for less cancer antecedents (11.5 vs 27.3%, P =0.02).…”
mentioning
confidence: 99%