Table 2.
Toxicities (Grade 3, 4, or 5)2 reported by high-risk neuroblastoma patients enrolled on COG study ANBL00P1 (n = 41)
| Induction Phase | CD34 selected PBSC (N = 14) | Unselected PBSC (N = 27) | Total (N=41) | ||||
|---|---|---|---|---|---|---|---|
| Count | Incidence (%) | Count | Incidence (%) | Count | Incidence (%) | ||
| Hepatotoxicity | Ascites (non-malignant) | 0 | 0.0 | 2 | 7.4 | 2 | 4.9 |
| AST elevation | 2 | 14.3 | 2 | 7.4 | 4 | 9.8 | |
| Documented infection | Catheter-related infection | 6 | 42.9 | 3 | 11.1 | 9 | 22.0 |
| Infection with grade 3 or 4 neutropenia | 8 | 57.1 | 14 | 51.9 | 22 | 53.7 | |
| Non-neutropenic infection | 3 | 21.4 | 5 | 18.5 | 8 | 19.5 | |
| Lung toxicity | Acute respiratory distress syndrome | 1 | 7.1 | 1 | 3.7 | 2 | 4.9 |
| Nephrotoxicity | Hypokalemia | 5 | 35.7 | 9 | 33.3 | 14 | 34.1 |
| HDC/SCR #1 | CD34 selected PBSC (N = 11) | Unselected PBSC (N = 22) | Total (N=33) | ||||
| Hepatotoxicity | ALT elevation | 1 | 9.1 | 1 | 4.5 | 2 | 6.1 |
| Documented infection | Catheter-related infection | 2 | 18.2 | 2 | 9.1 | 4 | 12.1 |
| Infection with grade 3 or 4 neutropenia | 4 | 36.4 | 4 | 18.2 | 8 | 24.2 | |
| Non-neutropenic infection | 1 | 9.1 | 4 | 18.2 | 5 | 15.2 | |
| Infection/febrile neutropenia – Other | 1 | 9.1 | 0 | 0.0 | 1 | 3.0 | |
| Nephrotoxicity | Syndrome of inappropriate antidiuretic hormone | 1 | 9.1 | 0 | 0.0 | 1 | 3.0 |
| Hypokalemia | 1 | 9.1 | 6 | 27.3 | 7 | 21.2 | |
| HDC/SCR #2 | CD34 selected PBSC (N = 8) | Unselected PBSC (N = 18) | Total (N=26) | ||||
| Hepatotoxicity | Weight gain - veno-occlusive disease (VOD) | 0 | 0.0 | 1 | 5.6 | 1 | 3.8 |
| Ascites | 0 | 0.0 | 1 | 5.6 | 1 | 3.8 | |
| Bilirubin | 0 | 0.0 | 3 | 16.7 | 3 | 11.5 | |
| Hepatic enlargement | 0 | 0.0 | 3 | 16.7 | 3 | 11.5 | |
| Hypoalbuminemia | 0 | 0.0 | 2 | 11.1 | 2 | 7.7 | |
| Portal vein flow | 0 | 0.0 | 1 | 5.6 | 1 | 3.8 | |
| AST elevation | 2 | 25.0 | 2 | 11.1 | 4 | 15.4 | |
| ALT elevation | 1 | 12.5 | 4 | 22.2 | 5 | 19.2 | |
| Hepatic – Other | 0 | 0.0 | 2 | 11.1 | 2 | 7.7 | |
| Documented infection | Catheter-related infection | 0 | 0.0 | 2 | 11.1 | 2 | 7.7 |
| Infection with grade 3 or 4 neutropenia | 2 | 25.0 | 7 | 38.9 | 9 | 34.6 | |
| Non-neutropenic infection | 1 | 12.5 | 2 | 11.1 | 3 | 11.5 | |
| Nephrotoxicity | Renal failure | 0 | 0.0 | 1 | 5.6 | 1 | 3.8 |
| Hypokalemia | 5 | 62.5 | 6 | 33.3 | 11 | 42.3 | |
2
Grade 5 toxicities included one patient who died of sepsis on day 14 following HDC/SCR #1 and one patient who died of complications of VOD on day +14 of HDC/SCR #2.