Table 2.
Comparison of toxicity between patients treated with (Group A) or without (Group B) vincristine plus dexamethasone pulses during the second year of continuation treatment.
| Toxicity* | Low-Risk ALL | Intermediate-/High-Risk ALL | Intermediate-Risk ALL | ||||||
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| Group A n=1442(%) |
Group B n=1481 (%) |
P-value | Group A n=1071 (%) |
Group B n=1060 (%) |
P-value | Group A n=1056(%) |
Group B n=1051 (%) |
P-value | |
|
| |||||||||
| Grade 5 (fatal) infection | 2 (0.14) | 5 (0.34) | 0.45 | 6 (0.56) | 5 (0.47) | 0.99 | 6 (0.57) | 5 (0.48) | 0.99 |
| Grade 3/4 Infection | 62 (4.30) | 50 (3.38) | 0.21 | 75 (7.00) | 64 (6.04) | 0.38 | 71 (6.72) | 63 (5.99) | 0.53 |
| Grade 3/4 Sepsis | 15 (1.04) | 10 (0.68) | 0.32 | 19 (1.77) | 21 (1.98) | 0.75 | 18 (1.70) | 21 (2.00) | 0.63 |
| Grade 3/4 Pneumonia | 17 (1.18) | 18 (1.22) | 0.99 | 26 (2.43) | 10 (0.94) | 0.01 | 23 (2.18) | 10 (0.95) | 0.03 |
| Grade 3/4 Osteonecrosis | 1 (0.07) | 2 (0.14) | 0.99 | 6 (0.56) | 8 (0.75) | 0.60 | 6 (0.57) | 8 (0.76) | 0.61 |
| Grade 3/4 Hyperglycemia | 3 (0.21) | 1 (0.07) | 0.37 | 17 (1.59) | 10 (0.94) | 0.24 | 17 (1.61) | 10 (0.95) | 0.24 |
| Grade 3/4 Hypertension | 2 (0.14) | 0 | 0.24 | 1 (0.09) | 3 (0.28) | 0.37 | 0 | 3 (0.29) | 0.12 |
| Grade 3/4 Vincristine-related peripheral neuropathy | 14 (0.97) | 11 (0.74) | 0.55 | 17 (1.59) | 6 (0.57) | 0.03 | 17 (1.61) | 6(0.57) | 0.03 |
*
Grade 1/2 toxicities are not included.