Characteristics of patients in AML-HR trial by random assignment
. | FLA vs ADE, no. patients . | . | G-CSF vs no G-CSF, no. patients . | . | ATRA vs no ATRA, no. patients . | . | |||
---|---|---|---|---|---|---|---|---|---|
. | FLA . | ADE . | G-CSF . | None . | ATRA . | None . | |||
No. randomly assigned | 126 | 124 | 178 | 178 | 180 | 182 | |||
Type of high risk | |||||||||
Adverse genetics | 22 | 25 | 28 | 27 | 23 | 26 | |||
Not in CR at entry | 5 | 13 | 15 | 10 | 13 | 8 | |||
In CR at entry | 17 | 12 | 13 | 17 | 10 | 18 | |||
Resistant disease | 41 | 38 | 64 | 61 | 65 | 64 | |||
Refractory disease | 5 | 3 | 4 | 8 | 6 | 5 | |||
Relapse | 58 | 58 | 82 | 82 | 86 | 87 | |||
CR1 less than 1 y | 27 | 24 | 45 | 33 | 40 | 38 | |||
CR1 longer than 1 y | 31 | 34 | 37 | 49 | 46 | 49 | |||
Age group | |||||||||
15-29 years of age | 12 | 15 | 16 | 19 | 14 | 16 | |||
30-39 years of age | 19 | 19 | 22 | 29 | 25 | 29 | |||
40-49 years of age | 21 | 20 | 34 | 25 | 33 | 27 | |||
50-59 years of age | 40 | 39 | 59 | 57 | 59 | 59 | |||
60-69 years of age | 27 | 23 | 38 | 40 | 40 | 42 | |||
70 years of age or older | 7 | 8 | 9 | 8 | 8 | 9 | |||
Sex | |||||||||
Female | 61 | 62 | 82 | 91 | 90 | 83 | |||
Male | 65 | 62 | 96 | 87 | 90 | 99 | |||
Type of AML | |||||||||
De novo | 108 | 105 | 153 | 155 | 153 | 156 | |||
Secondary | 18 | 19 | 25 | 23 | 27 | 20 | |||
Cytogenetic group | |||||||||
Favorable | 7 | 3 | 4 | 10 | 8 | 7 | |||
Intermediate | 45 | 44 | 66 | 65 | 66 | 68 | |||
Adverse | 34 | 25 | 42 | 36 | 35 | 34 | |||
Unknown | 40 | 52 | 66 | 67 | 71 | 73 | |||
Performance status | |||||||||
0 | 83 | 83 | 116 | 116 | 119 | 119 | |||
1 | 33 | 34 | 48 | 44 | 51 | 53 | |||
2 | 6 | 2 | 6 | 9 | 6 | 4 | |||
3 | 3 | 4 | 4 | 5 | 5 | 4 | |||
4 | 1 | 1 | 0 | 2 | 0 | 1 | |||
Prior transplantation | 1 | 3 | 3 | 4 | 3 | 4 | |||
Randomizations | |||||||||
FLA | — | — | 57 | 59 | 56 | 57 | |||
ADE | — | — | 59 | 58 | 57 | 55 | |||
Not randomized | — | — | 62 | 61 | 67 | 70 | |||
G-CSF | 59 | 57 | — | — | 79 | 80 | |||
No G-CSF | 58 | 59 | — | — | 80 | 80 | |||
Not randomized | 9 | 8 | — | — | 21 | 22 | |||
ATRA | 57 | 56 | 79 | 80 | — | — | |||
No ATRA | 55 | 57 | 80 | 80 | — | — | |||
Not randomized | 14 | 11 | 19 | 18 | — | — |
. | FLA vs ADE, no. patients . | . | G-CSF vs no G-CSF, no. patients . | . | ATRA vs no ATRA, no. patients . | . | |||
---|---|---|---|---|---|---|---|---|---|
. | FLA . | ADE . | G-CSF . | None . | ATRA . | None . | |||
No. randomly assigned | 126 | 124 | 178 | 178 | 180 | 182 | |||
Type of high risk | |||||||||
Adverse genetics | 22 | 25 | 28 | 27 | 23 | 26 | |||
Not in CR at entry | 5 | 13 | 15 | 10 | 13 | 8 | |||
In CR at entry | 17 | 12 | 13 | 17 | 10 | 18 | |||
Resistant disease | 41 | 38 | 64 | 61 | 65 | 64 | |||
Refractory disease | 5 | 3 | 4 | 8 | 6 | 5 | |||
Relapse | 58 | 58 | 82 | 82 | 86 | 87 | |||
CR1 less than 1 y | 27 | 24 | 45 | 33 | 40 | 38 | |||
CR1 longer than 1 y | 31 | 34 | 37 | 49 | 46 | 49 | |||
Age group | |||||||||
15-29 years of age | 12 | 15 | 16 | 19 | 14 | 16 | |||
30-39 years of age | 19 | 19 | 22 | 29 | 25 | 29 | |||
40-49 years of age | 21 | 20 | 34 | 25 | 33 | 27 | |||
50-59 years of age | 40 | 39 | 59 | 57 | 59 | 59 | |||
60-69 years of age | 27 | 23 | 38 | 40 | 40 | 42 | |||
70 years of age or older | 7 | 8 | 9 | 8 | 8 | 9 | |||
Sex | |||||||||
Female | 61 | 62 | 82 | 91 | 90 | 83 | |||
Male | 65 | 62 | 96 | 87 | 90 | 99 | |||
Type of AML | |||||||||
De novo | 108 | 105 | 153 | 155 | 153 | 156 | |||
Secondary | 18 | 19 | 25 | 23 | 27 | 20 | |||
Cytogenetic group | |||||||||
Favorable | 7 | 3 | 4 | 10 | 8 | 7 | |||
Intermediate | 45 | 44 | 66 | 65 | 66 | 68 | |||
Adverse | 34 | 25 | 42 | 36 | 35 | 34 | |||
Unknown | 40 | 52 | 66 | 67 | 71 | 73 | |||
Performance status | |||||||||
0 | 83 | 83 | 116 | 116 | 119 | 119 | |||
1 | 33 | 34 | 48 | 44 | 51 | 53 | |||
2 | 6 | 2 | 6 | 9 | 6 | 4 | |||
3 | 3 | 4 | 4 | 5 | 5 | 4 | |||
4 | 1 | 1 | 0 | 2 | 0 | 1 | |||
Prior transplantation | 1 | 3 | 3 | 4 | 3 | 4 | |||
Randomizations | |||||||||
FLA | — | — | 57 | 59 | 56 | 57 | |||
ADE | — | — | 59 | 58 | 57 | 55 | |||
Not randomized | — | — | 62 | 61 | 67 | 70 | |||
G-CSF | 59 | 57 | — | — | 79 | 80 | |||
No G-CSF | 58 | 59 | — | — | 80 | 80 | |||
Not randomized | 9 | 8 | — | — | 21 | 22 | |||
ATRA | 57 | 56 | 79 | 80 | — | — | |||
No ATRA | 55 | 57 | 80 | 80 | — | — | |||
Not randomized | 14 | 11 | 19 | 18 | — | — |
— indicates not applicable.