Induction toxicity according to randomization group
| Toxicity type . | ICE group (n = 286) . | sHD group (n = 286) . | P . |
|---|---|---|---|
| Hematologic toxicity (recovery time), median days (range) from treatment day 1 | |||
| Neutrophil count, ×109/L | |||
| >0.5 | 21 (8-54) | 27 (13-114) | <.0001 |
| >1.5 (G-CSF stopped) | 22 (10-57) | 28 (14-66) | <.0001 |
| Platelet count, ×109/L | |||
| >20 | 21 (10-58) | 29 (15-76) | <.0001 |
| >50 | 23 (11-56) | 32 (17-90) | <.0001 |
| Fever and infections (clinical picture and etiology), n (%) | |||
| Fever >38°C | 222 | 254 | .0002 |
| Days with fever, median (range) | 5 (1-24) | 5 (1-40) | |
| FUO | 121 (42.6) | 121 (42.8) | .97 |
| Bacteremia | 45 (15.8) | 80 (28.3) | .0004 |
| Sepsis | 40 (14.1) | 63 (22.3) | .01 |
| Pneumonia | 59 (20.8) | 83 (29.3) | .01 |
| Other involved site | 73 (25.7) | 85 (30.0) | .25 |
| Gastrointestinal system | 31 (10.9) | 30 (10.6) | .90 |
| Skin | 48 (16.9) | 59 (20.8) | .22 |
| Urinary system | 1 (0.4) | 2 (0.7) | .99 |
| Central nervous system | 1 (0.4) | 3 (1.1) | .61 |
| Bacterial | 77 (27.1) | 122 (43.1) | .0001 |
| Gram+ | 56 (19.7) | 94 (33.2) | .0003 |
| Gram− | 28 (9.9) | 44 (15.5) | .04 |
| Fungal | 24 (8.5) | 47 (16.6) | .003 |
| Aspergillus spp. | 17 (6.0) | 37 (13.1) | .004 |
| Proven | 2 (0.7) | 5 (1.8) | |
| Probable | 13 (4.6) | 21 (7.4) | |
| Possible | 2 (0.7) | 11 (3.9) | |
| Candida spp. | 3 (1.1) | 7 (2.5) | .33 |
| Other | 4 (1.4) | 5 (1.8) | .99 |
| Parasitic | 2 (0.7) | 0 | .48 |
| Viral | 15 (5.3) | 16 (5.7) | .84 |
| Unknown | 123 (43.3) | 108 (38.2) | .21 |
| Other toxicity (type/organ), CTC grading, n | |||
| Hemorrhage | .16 | ||
| Any grade | 41 | 53 | |
| Grade >2 | 15 | 16 | |
| Cardiovascular system | .87 | ||
| Any grade | 19 | 18 | |
| Grade >2 | 9 | 8 | |
| Coagulation | .36 | ||
| Any grade | 12 | 8 | |
| Grade >2 | 8 | 6 | |
| Hepatobiliary system | .01 | ||
| Any grade | 65 | 91 | |
| Grade >2 | 23 | 28 | |
| Metabolism | .04 | ||
| Any grade | 51 | 70 | |
| Grade >2 | 18 | 22 | |
| Kidney | .28 | ||
| Any grade | 9 | 5 | |
| Grade >2 | 3 | 3 | |
| Amylase | 1.0 | ||
| Any grade | 4 | 2 | |
| Grade >2 | 1 | 1 | |
| Central/peripheral nervous system | .78 | ||
| Any grade | 7 | 6 | |
| Grade >2 | 2 | 3 | |
| Gastrointestinal system | .42 | ||
| Any grade | 125 | 134 | |
| Grade >2 | 39 | 46 | |
| Skin | .0003 | ||
| Any grade | 37 | 71 | |
| Grade >2 | 5 | 7 | |
| Lungs | .13 | ||
| Any grade | 25 | 36 | |
| Grade >2 | 10 | 18 | |
| Allergy | .73 | ||
| Any grade | 19 | 21 | |
| Grade >2 | 2 | 4 |
| Toxicity type . | ICE group (n = 286) . | sHD group (n = 286) . | P . |
|---|---|---|---|
| Hematologic toxicity (recovery time), median days (range) from treatment day 1 | |||
| Neutrophil count, ×109/L | |||
| >0.5 | 21 (8-54) | 27 (13-114) | <.0001 |
| >1.5 (G-CSF stopped) | 22 (10-57) | 28 (14-66) | <.0001 |
| Platelet count, ×109/L | |||
| >20 | 21 (10-58) | 29 (15-76) | <.0001 |
| >50 | 23 (11-56) | 32 (17-90) | <.0001 |
| Fever and infections (clinical picture and etiology), n (%) | |||
| Fever >38°C | 222 | 254 | .0002 |
| Days with fever, median (range) | 5 (1-24) | 5 (1-40) | |
| FUO | 121 (42.6) | 121 (42.8) | .97 |
| Bacteremia | 45 (15.8) | 80 (28.3) | .0004 |
| Sepsis | 40 (14.1) | 63 (22.3) | .01 |
| Pneumonia | 59 (20.8) | 83 (29.3) | .01 |
| Other involved site | 73 (25.7) | 85 (30.0) | .25 |
| Gastrointestinal system | 31 (10.9) | 30 (10.6) | .90 |
| Skin | 48 (16.9) | 59 (20.8) | .22 |
| Urinary system | 1 (0.4) | 2 (0.7) | .99 |
| Central nervous system | 1 (0.4) | 3 (1.1) | .61 |
| Bacterial | 77 (27.1) | 122 (43.1) | .0001 |
| Gram+ | 56 (19.7) | 94 (33.2) | .0003 |
| Gram− | 28 (9.9) | 44 (15.5) | .04 |
| Fungal | 24 (8.5) | 47 (16.6) | .003 |
| Aspergillus spp. | 17 (6.0) | 37 (13.1) | .004 |
| Proven | 2 (0.7) | 5 (1.8) | |
| Probable | 13 (4.6) | 21 (7.4) | |
| Possible | 2 (0.7) | 11 (3.9) | |
| Candida spp. | 3 (1.1) | 7 (2.5) | .33 |
| Other | 4 (1.4) | 5 (1.8) | .99 |
| Parasitic | 2 (0.7) | 0 | .48 |
| Viral | 15 (5.3) | 16 (5.7) | .84 |
| Unknown | 123 (43.3) | 108 (38.2) | .21 |
| Other toxicity (type/organ), CTC grading, n | |||
| Hemorrhage | .16 | ||
| Any grade | 41 | 53 | |
| Grade >2 | 15 | 16 | |
| Cardiovascular system | .87 | ||
| Any grade | 19 | 18 | |
| Grade >2 | 9 | 8 | |
| Coagulation | .36 | ||
| Any grade | 12 | 8 | |
| Grade >2 | 8 | 6 | |
| Hepatobiliary system | .01 | ||
| Any grade | 65 | 91 | |
| Grade >2 | 23 | 28 | |
| Metabolism | .04 | ||
| Any grade | 51 | 70 | |
| Grade >2 | 18 | 22 | |
| Kidney | .28 | ||
| Any grade | 9 | 5 | |
| Grade >2 | 3 | 3 | |
| Amylase | 1.0 | ||
| Any grade | 4 | 2 | |
| Grade >2 | 1 | 1 | |
| Central/peripheral nervous system | .78 | ||
| Any grade | 7 | 6 | |
| Grade >2 | 2 | 3 | |
| Gastrointestinal system | .42 | ||
| Any grade | 125 | 134 | |
| Grade >2 | 39 | 46 | |
| Skin | .0003 | ||
| Any grade | 37 | 71 | |
| Grade >2 | 5 | 7 | |
| Lungs | .13 | ||
| Any grade | 25 | 36 | |
| Grade >2 | 10 | 18 | |
| Allergy | .73 | ||
| Any grade | 19 | 21 | |
| Grade >2 | 2 | 4 |
FUO, fever of unknown origin