Table 1.
Patient demographics, responses and survival
| Doses administered | Responses | Survival | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pt No. |
Age at Rx (years) |
MYCN status |
No. of prior relapses |
Pre- study status |
Pre-study MIBG score |
131I-MIBG (actual) (MBq/kg) |
AT (mg/kg/day) |
INRC | Relative MIBG score |
PFS (months) |
OS (months) |
| Metastatic pheochromocytoma/paraganglioma | |||||||||||
| 1 | 9.8 | N/A | 1 | SD | 7 | 656.6 | 0.15 | N/A | 1.00 | 63.1‡ | 63.1‡ |
| 2 | 13.3 | N/A | 1 | SD | 9 | 668.4 | 0.15 | N/A | 1.00 | 100.2‡ | 100.2‡ |
| Neuroblastoma | |||||||||||
| 3 | 9.2 | NA | 1 | SD | 13 | 444 | 0.15 | NR | 0.85 | 100.6‡ | 100.6‡ |
| 4 | 7.7 | NA | 0 | SD | 11 | 462.5 | 0.15 | NR | 1.00 | 79.2 | 99.0‡ |
| 5 | 9.9 | NA | 1 | SD | 8 | 673.2 | 0.15 | NR | 0.88 | 94.1‡ | 94.1‡ |
| 6 | 6.0 | NA | 2 | PD | 6 | 669.7 | 0* | NR | 1.00 | 6.5 | 15.5 |
| 7 | 2.0 | A | 0 | SD | 2† | 647.5 | 0.25 | NR | 1.00 | 91.8‡ | 91.8‡ |
| 8 | 2.8 | NA | 1 | SD | 20 | 677.1 | 0.25 | NR | 1.00 | 83.3‡ | 83.3‡ |
| 9 | 3.3 | A | 2 | PD | 2† | 662.3 | 0.25 | PD | 1.00 | 0.9 | 3.7 |
| 10 | 4.7 | NA | 0 | SD | 14 | 632.7 | 0.25 | NR | 1.00 | 71.8‡ | 71.8‡ |
| 11 | 5.8 | NA | 5 | PD | 2† | 662.3 | 0.25 | PD | 1.00 | 0.7 | 4.8 |
| 12 | 6.1 | A | 2 | PD | 21 | 691.9 | 0.25 | PD | 0.90 | 2.8 | 4.0 |
| 13 | 6.1 | NA | 4 | PD | 2† | 677.1 | 0.25 | PD | 1.00 | 1.4 | 8.7 |
| 14 | 6.2 | A | 3 | SD | 5 | 662.3 | 0.25 | PD | 1.00 | 6.5 | 14.4 |
| 15 | 7.8 | NA | 4 | SD | 13 | 636.4 | 0.25 | NR | 1.00 | 3.7 | 14.7 |
| 16 | 8.3 | NA | 3 | SD | 21 | 658.6 | 0.25 | NR | 0.95 | 3.6 | 8.8 |
| 17 | 8.4 | NA | 0 | SD | 9 | 684.5 | 0.25 | NR | 0.88 | 83.3‡ | 83.3‡ |
| 18 | 8.4 | NA | 1 | PD | 10 | 654.9 | 0.25 | PD | 1.30 | 1.2 | 27.2 |
| 19 | 8.7 | NA | 3 | PD | 6 | 688.2 | 0.25 | PD | 1.50 | 1.2 | 9.8 |
| 20 | 15.2 | NA | 1 | SD | 9 | 647.5 | 0.25 | NR | 1.00 | 6.2 | 23.7 |
| 21 | 30.4 | NA | 2 | PD | 8 | 658.6 | 0.25§ | NR | 0.63 | 11.5 | 61.6 |
Abbreviations and Legend: A: Amplified; AT: Arsenic trioxide; INRC: International Neuroblastoma Response Criteria, N/A: not applicable; NA: Not amplified, No.: number, NR: No response; OS: overall survival; PFS: progression-free survival; PD: progressive disease; Pt: patient; Rx: treatment; SD: stable disease.
*
AT not administered due to central-line induced arrhythmia;
†
MIBG-avid soft tissue disease only;
‡
continue to be progression-free;
§
6/10 planned AT doses administered due to diarrhea and electrolyte imbalance