How is therapy-related acute myeloid leukemia (AML) treated?

Updated: May 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Patients who develop AML as a complication of conventional chemoradiotherapy for a primary malignancy have traditionally had a poor prognosis, with a median survival of only 6 months. Allogeneic HCT has generally been recommended because these cases respond poorly to traditional chemotherapy. [83]

In August 2017, the FDA approved a fixed-dose combination of cytarabine and daunorubicin liposomal (CPX-351; Vyxeos) for newly diagnosed therapy-related AML and AML with myelodysplasia-related changes. Approval was based on a phase III trial in 309 patients aged 60-75 years that evaluated the efficacy and safety of the combination product with cytarabine and daunorubicin given separately in the 3+7 regimen (daunorubicin, 60 mg/m2 on days 1, 2, and 3; cytarabine, 100 mg/m2/day x 7 days;). [72]

The CR or CRi rate was 47.7% for the combination compared with 33.3% for 3+7. For CR alone, the rates were 37.3% for the combination and 25.6% percent for 3+7. OS at 12 and 24 months for the fixed-dose combination was 41.5% and 31.1%, respectively, compared with 3+7 OS of 27.6% and 12.3%. [72]

In an exploratory analysis of the phase III study for those with secondary untreated AML, 34 of the 52 patients (65%) in the fixed-dose combination arm who proceeded to transplant remained alive after a median follow-up of 521 days. In the 3+7 arm, after 442 days of follow-up, 13 of 39 patients remained alive (33%). [72]

The principal role for CPX-351 appears to be in patients with a history of myelodysplastic syndrome who were never treated with a hypomethylating agent (eg, azacitidine, decitabine). In these patients, the combination may not only improve outcome but increase eligibility for transplantation. Adverse effects of CPX-351 are the same as with the standard 3+7 regimen, so for unfit/elderly patients, hypomethylating agents remain the preferred therapy. [84]


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