Characteristics of 565 randomized patients
. | Randomized groups . | . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|
| . | STD DAT . | . | HD DAT . | . | . | |||
| Characteristic . | No CsA . | CsA . | No CsA . | CsA . | Total . | |||
| No. of patients | 145 | 139 | 138 | 143 | 565 | |||
| Race or ethnicity, no. (%) | ||||||||
| White | 97 (67) | 88 (63) | 85 (62) | 91 (64) | 361 (64) | |||
| Black | 24 (17) | 18 (13) | 20 (14) | 19 (13) | 81 (14) | |||
| Hispanic | 18 (12) | 20 (14) | 22 (16) | 26 (18) | 86 (15) | |||
| Other | 6 (4) | 13 (9) | 11 (8) | 7 (5) | 37 (7) | |||
| Sex, no. (%) | ||||||||
| Male | 77 (53) | 73 (53) | 70 (51) | 78 (55) | 298 (53) | |||
| Female | 68 (47) | 66 (47) | 68 (49) | 65 (45) | 267 (47) | |||
| Age, no. (%) | ||||||||
| Younger than 2 | 32 (22) | 33 (24) | 29 (21) | 24 (17) | 118 (21) | |||
| 2 or older | 113 (78) | 106 (76) | 109 (79) | 119 (83) | 447 (79) | |||
| Initial WBCs, no. (%) | ||||||||
| Fewer than 15 × 109/L | 68 (47) | 70 (50) | 44 (32) | 47 (33) | 229 (41) | |||
| 15-24 × 109/L | 14 (10) | 13 (9) | 22 (16) | 18 (13) | 67 (12) | |||
| 25-49 × 109/L | 17 (12) | 16 (12) | 20 (14) | 22 (15) | 75 (13) | |||
| 50 or more × 109/L | 46 (32) | 40 (29) | 52 (38) | 56 (39) | 194 (34) | |||
| FAB classification, no. (%) | ||||||||
| M0 | 5 (3) | 3 (2) | 6 (4) | 11 (8) | 25 (4) | |||
| M1 | 20 (14) | 29 (21) | 25 (18) | 28 (20) | 102 (18) | |||
| M2 | 37 (26) | 34 (24) | 40 (29) | 37 (26) | 148 (26) | |||
| M4 | 21 (14) | 19 (14) | 27 (20) | 24 (17) | 91 (16) | |||
| M5 | 35 (24) | 27 (19) | 25 (18) | 26 (18) | 113 (20) | |||
| M6 | 5 (3) | 1 (1) | 1 (1) | 1 (1) | 8 (1) | |||
| M7 | 10 (7) | 16 (12) | 12 (9) | 11 (8) | 49 (9) | |||
| Granulocytic sarcoma | 1 (1) | 2 (1) | 1 (1) | 1 (1) | 5 (1) | |||
| Other | 11 (8) | 8 (6) | 1 (1) | 4 (3) | 24 (4) | |||
| Karyotype, no. (%) | ||||||||
| Normal | 31 (21) | 36 (26) | 38 (28) | 39 (27) | 144 (25) | |||
| t(8;21) | 14 (10) | 17 (12) | 16 (12) | 12 (8) | 59 (10) | |||
| inv(16) | 10 (7) | 6 (4) | 9 (6) | 13 (9) | 38 (7) | |||
| 11 q23 abnormalities | 18 (12) | 27 (19) | 19 (14) | 20 (14) | 84 (15) | |||
| Miscellaneous | 45 (31) | 31 (22) | 31 (22) | 40 (28) | 147 (26) | |||
| Not reviewed | 27 (19) | 22 (16) | 25 (18) | 19 (13) | 93 (16) | |||
| Evaluable for response, no. | 144 | 138 | 135 | 143 | 560 | |||
| Response, no. (%) | ||||||||
| M1 marrow | 114 (94) | 120 (94) | 116 (95) | 125 (95) | 475 (95) | |||
| M2a marrow | 7 (6) | 7 (6) | 6 (5) | 6 (5) | 26 (5) | |||
| Remission rate, % | 84.0 | 92.0 | 90.4 | 91.6 | 89.5 | |||
| Remission after induction, no. (%) | ||||||||
| Induction 1 | 86 (71) | 92 (72) | 79 (65) | 101 (77) | 358 (71) | |||
| Induction 2 | 35 (29) | 35 (28) | 43 (35) | 30 (23) | 143 (29) | |||
| MDR positive*, no./no. tested (%) | 15/108 (13.9%) | 17/107 (15.9%) | 16/113 (14.2%) | 14/119 (11.8%) | 62/447 (13.9%) | |||
| 3-year EFS estimate ± SE, % | 29.2 ± 3.9 | 41.6 ± 4.5 | 37.6 ± 4.4 | 42.5 ± 4.3 | 36.3 ± 2.2 | |||
| 3-year OS estimate ± SE, % | 55.2 ± 4.2 | 52.8 ± 4.4 | 50.7 ± 4.3 | 55.5 ± 4.2 | 53.6 ± 2.2 | |||
. | Randomized groups . | . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|
| . | STD DAT . | . | HD DAT . | . | . | |||
| Characteristic . | No CsA . | CsA . | No CsA . | CsA . | Total . | |||
| No. of patients | 145 | 139 | 138 | 143 | 565 | |||
| Race or ethnicity, no. (%) | ||||||||
| White | 97 (67) | 88 (63) | 85 (62) | 91 (64) | 361 (64) | |||
| Black | 24 (17) | 18 (13) | 20 (14) | 19 (13) | 81 (14) | |||
| Hispanic | 18 (12) | 20 (14) | 22 (16) | 26 (18) | 86 (15) | |||
| Other | 6 (4) | 13 (9) | 11 (8) | 7 (5) | 37 (7) | |||
| Sex, no. (%) | ||||||||
| Male | 77 (53) | 73 (53) | 70 (51) | 78 (55) | 298 (53) | |||
| Female | 68 (47) | 66 (47) | 68 (49) | 65 (45) | 267 (47) | |||
| Age, no. (%) | ||||||||
| Younger than 2 | 32 (22) | 33 (24) | 29 (21) | 24 (17) | 118 (21) | |||
| 2 or older | 113 (78) | 106 (76) | 109 (79) | 119 (83) | 447 (79) | |||
| Initial WBCs, no. (%) | ||||||||
| Fewer than 15 × 109/L | 68 (47) | 70 (50) | 44 (32) | 47 (33) | 229 (41) | |||
| 15-24 × 109/L | 14 (10) | 13 (9) | 22 (16) | 18 (13) | 67 (12) | |||
| 25-49 × 109/L | 17 (12) | 16 (12) | 20 (14) | 22 (15) | 75 (13) | |||
| 50 or more × 109/L | 46 (32) | 40 (29) | 52 (38) | 56 (39) | 194 (34) | |||
| FAB classification, no. (%) | ||||||||
| M0 | 5 (3) | 3 (2) | 6 (4) | 11 (8) | 25 (4) | |||
| M1 | 20 (14) | 29 (21) | 25 (18) | 28 (20) | 102 (18) | |||
| M2 | 37 (26) | 34 (24) | 40 (29) | 37 (26) | 148 (26) | |||
| M4 | 21 (14) | 19 (14) | 27 (20) | 24 (17) | 91 (16) | |||
| M5 | 35 (24) | 27 (19) | 25 (18) | 26 (18) | 113 (20) | |||
| M6 | 5 (3) | 1 (1) | 1 (1) | 1 (1) | 8 (1) | |||
| M7 | 10 (7) | 16 (12) | 12 (9) | 11 (8) | 49 (9) | |||
| Granulocytic sarcoma | 1 (1) | 2 (1) | 1 (1) | 1 (1) | 5 (1) | |||
| Other | 11 (8) | 8 (6) | 1 (1) | 4 (3) | 24 (4) | |||
| Karyotype, no. (%) | ||||||||
| Normal | 31 (21) | 36 (26) | 38 (28) | 39 (27) | 144 (25) | |||
| t(8;21) | 14 (10) | 17 (12) | 16 (12) | 12 (8) | 59 (10) | |||
| inv(16) | 10 (7) | 6 (4) | 9 (6) | 13 (9) | 38 (7) | |||
| 11 q23 abnormalities | 18 (12) | 27 (19) | 19 (14) | 20 (14) | 84 (15) | |||
| Miscellaneous | 45 (31) | 31 (22) | 31 (22) | 40 (28) | 147 (26) | |||
| Not reviewed | 27 (19) | 22 (16) | 25 (18) | 19 (13) | 93 (16) | |||
| Evaluable for response, no. | 144 | 138 | 135 | 143 | 560 | |||
| Response, no. (%) | ||||||||
| M1 marrow | 114 (94) | 120 (94) | 116 (95) | 125 (95) | 475 (95) | |||
| M2a marrow | 7 (6) | 7 (6) | 6 (5) | 6 (5) | 26 (5) | |||
| Remission rate, % | 84.0 | 92.0 | 90.4 | 91.6 | 89.5 | |||
| Remission after induction, no. (%) | ||||||||
| Induction 1 | 86 (71) | 92 (72) | 79 (65) | 101 (77) | 358 (71) | |||
| Induction 2 | 35 (29) | 35 (28) | 43 (35) | 30 (23) | 143 (29) | |||
| MDR positive*, no./no. tested (%) | 15/108 (13.9%) | 17/107 (15.9%) | 16/113 (14.2%) | 14/119 (11.8%) | 62/447 (13.9%) | |||
| 3-year EFS estimate ± SE, % | 29.2 ± 3.9 | 41.6 ± 4.5 | 37.6 ± 4.4 | 42.5 ± 4.3 | 36.3 ± 2.2 | |||
| 3-year OS estimate ± SE, % | 55.2 ± 4.2 | 52.8 ± 4.4 | 50.7 ± 4.3 | 55.5 ± 4.2 | 53.6 ± 2.2 | |||
More than 5% MRK16