Table 1.
Baseline characteristics of the entire patient population
| Characteristic | No. |
|---|---|
| Number of patients | 420 |
| Gender | |
| Male/Female | 288/132 |
| Age, years | |
| Median (range) | 50 (21–73) |
| Hematological malignancy | 420 |
| de novo AML | 357 |
| Secondary AML | 50 |
| Blast crisis of chronic myeloprolipherative diseases | 13 |
| Cytarabine‐based cytotoxic agent protocols | 420 |
| Standard‐dose cytarabine | |
| Induction course of EORTC‐GIMEMA AML‐10 trial | 200 |
| Intermediate‐dose cytarabine | |
| Induction course of HOVON‐SAKK trial | 100 |
| High‐dose cytarabine | |
| Induction course of FLAG‐Ida trial | 71 |
| Induction course of EORTC‐GIMEMA AML‐12 trial | 49 |
| Percentage of dose intensity administered | |
| Median (range) | 90% (80–100%) |
Unless otherwise specified data refer to the number of patients.
EORTC‐GIMEMA AML‐10 protocol: the schedule of induction course contained continuous i.v. infusion of cytarabine 100 mg/m2 daily for 10 days plus etoposide 100 mg/m2 per day by 1‐h i.v. infusion on days 1 through 5 plus daunorubicin 50 mg/m2 per day as a 5‐min i.v. infusion (n = 127 patients) or idarubicin 10 mg/m2 as a 5‐min i.v. infusion (n = 53 patients) or mitoxantrone 12 mg/m2 as a 30‐min i.v. infusion (n = 20 patients) on days 1, 3, and 5 [ref. 16].
HOVON‐SAKK protocol: the schedule of induction course contained continuous i.v. infusion of cytarabine 200 mg/m2 daily for 7 days plus idarubicin 12 mg/m2 daily as a 3‐h i.v. infusion on days 5 through 7 [ref. 17].
FLAG‐Ida protocol: the schedule of induction course contained cytarabine 2000 mg/m2 daily as 3‐h i.v. infusion for 4 days plus fludarabine 30 mg/m2 daily as 30 min i.v. infusion for 4 days plus idarubicin 12 mg/m2 daily as a 1‐h i.v. infusion on days 2 through 4 [ref. 18].
EORTC‐GIMEMA AML‐12 protocol: the schedule of induction course contained cytarabine 3000 mg/m2 every 12 h as 3‐h i.v. infusion on days 1, 3, 5, and 7 plus daunorubicin 50 mg/m2 per day as a 5‐minute i.v. infusion on days 1, 3, and 5 plus etoposide 50 mg/m2 per day by 1‐h i.v. infusion on days 1 through 5 [ref. 19].
AML, acute myeloid leukemia; EORTC, European Organization for Research and Treatment of Cancer; GIMEMA, Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto; HOVON‐SAKK, Dutch‐Belgian Cooperative Group for Hemato‐Oncology and Swiss Group for clinical research; FLAG‐Ida, fludarabine–cytarabine–idarubicin plus granulocyte colony‐stimulating factors.