Toxicity of consolidation therapy
| Toxicity . | P1 arm . | P2 arm: TSC (93 patients) . | |||
|---|---|---|---|---|---|
| HDAraC 1 (110 patients) . | HDAraC 2 (95 patients) . | HDAraC 3 (81 patients) . | HDAraC 4 (74 patients) . | ||
| Extrahematologic (WHO grade ≥ 3), % | |||||
| Bilirubin | 0 | 1 | 0 | 1 | 10 |
| AST | 1 | 1 | 0 | 0 | 1 |
| ALT | 2 | 4 | 4 | 4 | 7 |
| ALP | 5 | 0 | 0 | 0 | 0 |
| GGT | 1 | 1 | 3 | 3 | 22 |
| Mucositis | 3 | 0 | 0 | 0 | 26 |
| Nausea/vomiting | 3 | 0 | 5 | 0 | 24 |
| Diarrhea | 1 | 1 | 3 | 3 | 24 |
| Creatinine | 0 | 0 | 0 | 0 | 0 |
| Hemostasis | 0 | 0 | 0 | 0 | 6 |
| Cutaneous | 0 | 0 | 0 | 0 | 5 |
| Allergy | 0 | 0 | 0 | 0 | 3 |
| Cardiac | 0 | 0 | 0 | 0 | 3 |
| Pulmonary | 1 | 0 | 1 | 0 | 15 |
| Other | 4* | 0 | 0 | 0 | 0 |
| Infection | |||||
| WHO grade ≥ 3, % | 16 | 18 | 19 | 10 | 39 |
| Days with fever | 3 | 4 | 2 | 2 | 16 |
| Days with antibiotics | 8 | 10 | 8 | 8 | 35 |
| Hematologic | |||||
| WBCs < 1 × 109/L, d | 13 | 14 | 12 | 13 | 37 |
| ANC < 0.5 × 109/L, d | 15 | 14 | 14 | 14 | 37 |
| Platelets < 50 × 109/L, d | 17 | 16 | 17 | 16 | 47 |
| Platelets < 100 × 109/L, d | 23 | 25 | 23 | 27 | 62 |
| RBC transfusions | 6 | 5 | 4 | 4 | 10 |
| Platelet transfusions | 4 | 4 | 3 | 4 | 12 |
| Toxicity . | P1 arm . | P2 arm: TSC (93 patients) . | |||
|---|---|---|---|---|---|
| HDAraC 1 (110 patients) . | HDAraC 2 (95 patients) . | HDAraC 3 (81 patients) . | HDAraC 4 (74 patients) . | ||
| Extrahematologic (WHO grade ≥ 3), % | |||||
| Bilirubin | 0 | 1 | 0 | 1 | 10 |
| AST | 1 | 1 | 0 | 0 | 1 |
| ALT | 2 | 4 | 4 | 4 | 7 |
| ALP | 5 | 0 | 0 | 0 | 0 |
| GGT | 1 | 1 | 3 | 3 | 22 |
| Mucositis | 3 | 0 | 0 | 0 | 26 |
| Nausea/vomiting | 3 | 0 | 5 | 0 | 24 |
| Diarrhea | 1 | 1 | 3 | 3 | 24 |
| Creatinine | 0 | 0 | 0 | 0 | 0 |
| Hemostasis | 0 | 0 | 0 | 0 | 6 |
| Cutaneous | 0 | 0 | 0 | 0 | 5 |
| Allergy | 0 | 0 | 0 | 0 | 3 |
| Cardiac | 0 | 0 | 0 | 0 | 3 |
| Pulmonary | 1 | 0 | 1 | 0 | 15 |
| Other | 4* | 0 | 0 | 0 | 0 |
| Infection | |||||
| WHO grade ≥ 3, % | 16 | 18 | 19 | 10 | 39 |
| Days with fever | 3 | 4 | 2 | 2 | 16 |
| Days with antibiotics | 8 | 10 | 8 | 8 | 35 |
| Hematologic | |||||
| WBCs < 1 × 109/L, d | 13 | 14 | 12 | 13 | 37 |
| ANC < 0.5 × 109/L, d | 15 | 14 | 14 | 14 | 37 |
| Platelets < 50 × 109/L, d | 17 | 16 | 17 | 16 | 47 |
| Platelets < 100 × 109/L, d | 23 | 25 | 23 | 27 | 62 |
| RBC transfusions | 6 | 5 | 4 | 4 | 10 |
| Platelet transfusions | 4 | 4 | 3 | 4 | 12 |
AST indicates aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; GGT, γ-glutamyltransferase; WBCs, white blood cells; ANC, absolute neutrophil count; and RBC, red blood cells.
One patient presented pancreatitis and 3 patients a severe cerebellar syndrome.