High-dose Cytarabine Significantly Improves Disease-free Survival in Adult AML
Researchers randomly assigned 597 patients with newly diagnosed AML to receive intermediate- or conventional-dose cytarabine plus homoharringtonine and daunorubicin.
|The following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Cytarabine induction therapy with dose escalation is well-tolerated and prolongs disease-free survival (DFS) among patients with acute myeloid leukemia (AML) compared with conventional doses. The findings were presented at the 2017 American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.1
For this phase 3 study, researchers randomly assigned 597 patients with newly diagnosed AML to receive intermediate- (100 mg/m2/day on days 1 to 4, then 1000 mg/m2/day on days 5 to 7) or conventional-dose cytarabine (100 mg/m2/day on days 1 to 7) plus homoharringtonine and daunorubicin.
All patients who had a complete response (CR) were randomly assigned to receive cytarabine 1500 mg/m2 (intermediate dose) or 3000 mg/m2 (high dose) twice daily for 3 days plus an anthracycline (daunorubicin or mitoxane).
Of 591 evaluable patients, 77.4% and 86.8% of patients in the conventional-dose group vs the intermediate-dose group had a CR, respectively (P = .003).
After a median follow-up of 30.4 months, the 3-year DFS rate was 66.7% (95% CI, 60.4%-72.9%) vs 55.4% (95% CI, 48.3%-62.4%) for patients in the intermediate group vs the conventional group, respectively (P = .013).
The 3-year overall survival (OS) rate was 67.7% (95% CI, 61.8-73.7) vs 59.3% (95% CI, 53.1-65.5) for patients in the intermediate group vs the conventional group, respectively (P = .0604).
For non–adverse risk patients, the 3-year DFS rate was 69.7% in the intermediate-dose group and 56.1% for the conventional-dose group (P = .004); the 3-year OS rate was 72.0% in the intermediate-dose group and 60.8% in the conventional group (P = .017).
There were no significant differences observed between the conventional-dose and intermediate-dose group for early death within 30 days (1.4% vs 2.4%; P = .355) or in the duration of neutropenia (20 days vs 21 days; P = .520). Patients in the intermediate-dose group, however, had a significantly longer duration of recovery from thrombocytopenia (P = .020), and trended towards more bacterial sepsis (P = .092) and red blood cell transfusion (P = .093) compared with the conventional-dose group.
Read more of Cancer Therapy Advisor's coverage of the American Society of Hematology (ASH) 2017 meeting by visiting the conference page.
- Wei H, Wang Y, Lin D, et al. The intermediate dose verse conventional dose cytarabine in induction therapy in adult acute myeloid leukemia: a phase III randomized controlled trial. Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.