Table 5.
Treatment cycle | Cumulative | ||||||
---|---|---|---|---|---|---|---|
A1 | B1 | C1 | A2 | B2 | C2 | ||
No. of cycles evaluable | 207 | 210 | 206 | 194 | 171 | 160 | 1148 |
Hematologic events | |||||||
Hemoglobin <8.0 g/dL | 78 (38) | 65 (31) | 84 (41) | 87 (45) | 54 (32) | 59 (37) | 427 (37) |
White blood cells <2.0/µL | 164 (79) | 94 (45) | 134 (65) | 135 (70) | 89 (52) | 108 (68) | 724 (63) |
Leukopenia grade 4, <1.0/µL, | |||||||
duration, d (range) | 7 (1-22) | 3 (1-18) | 4 (1-24) | 3 (1-12) | 3 (1-27) | 4 (1-21) | |
Neutrophils <1.0/µL | 120 (58) | 55 (26) | 82 (40) | 92 (47) | 32 (19) | 72 (45) | 453 (39) |
Neutropenia grade 4, <0.5/µL, | |||||||
duration (range) | 6 d (1-22) | 4 d (1-6) | 5 d (1-14) | 4 d (1-14) | 3 d (1-13) | 4 d (1-8) | |
Platelets <50/µL | 149 (72) | 37 (18) | 134 (65) | 135 (70) | 59 (35) | 100 (63) | 614 (53) |
Thrombopenia grade 4, <10/µL, | |||||||
duration, d (range) | 2 (1-15) | 2 (1-5) | 2 (1-18) | 1 (1-8) | 2 (1-21) | 1 (1-4) | |
General disorders | |||||||
Fever | 8 (4) | 3 (1) | 8 (4) | 3 (2) | — | 2 (1) | 24 (2) |
Pain | 53 (26) | 44 (21) | 29 (14) | 27 (14) | 21 (12) | 18 (11) | 192 (17) |
Infection | 79 (38) | 36 (17) | 36 (17) | 49 (25) | 22 (13) | 30 (19) | 252 (22) |
Liver toxicity | |||||||
Bilirubin >3xN | 5 (2) | — | 2 (1) | 3 (2) | 1 | 1 | 12 (1) |
GOT/GPT >5xN | 56 (27) | 18 (9) | 17 (8) | 24 (12) | 6 (4) | 7 (4) | 128 (11) |
AP >5xN | 2 (1) | 1 | 1 | 1 | — | — | 5 |
Gastrointestinal | |||||||
Vomiting | 29 (14) | 22 (10) | 15 (7) | 20 (10) | 9 (5) | 5 (3) | 100 (9) |
Mucositis (stomatitis) | 74 (36) | 78 (37) | 51 (25) | 52 (27) | 43 (25) | 31 (19) | 329 (29) |
Diarrhea | 14 (7) | 8 (4) | 13 (6) | 6 (3) | 2 (1) | 4 (3) | 47 (4) |
Colitis | 2 (1) | 3 (1) | 6 (3) | 2 (1) | 1 | 1 | 15 (1) |
Vascular | |||||||
Bleeding | 6 (3) | — | 5 (2) | 3 (2) | 1 | 2 (1) | 17 (1) |
Thromboembolic events | 3 (1) | 5 (2) | 3 (1) | 3 (2) | 2 (1) | 2 (1) | 18 (2) |
Other | |||||||
Lung | 9 (4) | 5 (2) | 3 (1) | 9 (5) | 2 (1) | 1 | 29 (3) |
Cardiac | 2 (1) | — | 1 | 3 (2) | 3 (2) | 1 | 10 (1) |
Neurologic | — | 3 (1) | 2 | 1 | 2 (1) | — | 8 (1) |
Skin reaction | 2 (1) | 1 | 1 | 3 (2) | 1 | — | 8 (1) |
Fibrinogen <100 mg/dL | 1 | 1 | — | 1 | — | — | 3 |
ATIII <40% | 1 | — | — | 1 | 2 (1) | — | 4 |
Creatinine >3xN | 4 (2) | 1 | 2 | 1 | 2 (1) | — | 10 (1) |
Values are n (%) unless otherwise indicated.
AP, alkaline phosphatase; ATIII, antithrombin III; GOT/GPT, glutamate oxaloacetate transaminase/glutamate pyruvate transaminase; —, none.