Table 5.
Grade 3 and 4 toxicity with or without dexrazoxane
| Without dexrazoxane |
With dexrazoxane |
|||
|---|---|---|---|---|
| Count (n = 108) | Incidence, % | Count (n = 106) | Incidence, % | |
| ANC grade 4* | 84 | 77.8 | 99 | 93.4 |
| ANC grade 3 | 9 | 8.3 | 1 | 0.9 |
| Platelets* | 32 | 29.6 | 77 | 72.6 |
| Hemoglobin* | 44 | 40.7 | 64 | 60.4 |
| Thrombosis* | 1 | 0.9 | 4 | 3.8 |
| Infection, not otherwise specified/unknown* | 48 | 44.4 | 75 | 70.8 |
| Sepsis* | 9 | 8.4 | 18 | 17.0 |
| Typhlitis | 9 | 8.4 | 3 | 2.8 |
| Pulmonary*† | 3 | 2.8 | 13 | 12.3 |
| Cardiac function | 2 | 1.9 | 0 | 0 |
| Peripheral nervous system/central nervous system‡ | 3/0 | 2.8/0 | 2/1 | 1.9/0.9 |
| Stomatitis | 31 | 28.7 | 30 | 28.3 |
| Vomiting/nausea | 10 | 9.3 | 10 | 9.4 |
| Allergic reaction | 2 | 1.9 | 7 | 6.6 |
| Secondary malignancy | 1 | 0.9 | 3 | 2.8 |
Significant grade 3 toxicities that occurred in more than 5% of patients, all grade 4 toxicities, and specific targeted toxicities (pulmonary, cardiac, peripheral nervous system) are included above. Except as specified (eg, ANC), the numbers represent combined grade 3 and grade 4 toxicities.
ANC indicates absolute neutrophil count.
*
Statistically significantly different (log-rank test, P ≤ .05).
†
Includes diffusion capacity for carbon monoxide, vital capacity, pulmonary/functional and oxygen saturation.
‡
Central nervous system includes mood, cortical, and cerebellar.