Table II.
Patient Characteristics
| Level | Age (months), Gender |
Wt (kg) |
Disease Sites |
Histology31 /MYCN |
Adequate PBSC Yield (Yes/No) |
DLT (cycle/harvest # occurred) |
BM Status Cycle 2 |
PBSC Immuno (# pos /tested) |
Response End Induction I |
Response End Induction II |
EFS |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 20, M | 11 | A, BM, B |
UH/ND | Yes | PLT (1, 2) | Pos | 0/3 | PR | Off | DOD |
| 1 | 31, M | 13.7 | A, BM, B |
UH/ amp | Yes | - | Neg | 0/3 | PR | CR* | DOD |
| 1 | 60,F | 17.2 | A, BM, B |
ND | No | PLT (1) PBSC (1) |
Neg | 0/5 | PR | off | CCR |
| 1 | 25, M | 10.4 | A, B, LN |
UH/ amp | Yes | - | Neg | 0/2 | PR | PR | DOT+ |
| 1 | 54, M | 14.8 | A, BM, B, LN |
ND | Yes | PLT (2, 3) | Pos | 0/3 | PR | PD | DOD |
| 1 | 14, M | 10.2 | A, BM, B |
ND | N/A | N/A | Pos | N/A | PD | - | DOD |
| 1 | 15, M | 13 | C, BM, B |
FH/ amp | No | PLT (1) PBSC (2) |
Neg | 0/5 | PR | off | DOD |
| 1 | 93, F | 21.7 | RP, BM, B, LN |
ND/ non | No | PBSC (2) | Neg | 0/4 | PR | off | CCR |
| 0 | 32,M | 17.3 | A, BM, B, LN, L |
ND | Yes | PLT (1) | Pos | 0/1 | MR | PD after Cycle 5 |
DOD |
| 0 | 35, F | 16 | A, BM, B, L, LN |
ND | Yes | PLT (3) | Pos | 0/4 | PR | PR | DOD |
| 0 | 31, M | 11.2 | C, BM, B |
UH/ amp | Yes | - | Neg | 0/2 | MR | PR | DOD |
| 0 | 106, M | 25.4 | A, BM, B, LN |
ND | Yes | - | Neg | ND | MR | VGPR | DOD |
| 0 | 20, M | 17 | A, RP, BM, B, L |
UH/ amp | No | PLT (3) PBSC (3) |
Neg | 0/2 | SD | MR | DOD |
| 0 | 39, M | 16 | A, BM, B |
UH/ non | Yes | - | Pos | 0/2 | MR | MR | DOD |
| 0 | 38, M | 15.2 | A, BM, B, LN |
UH/ non | Yes | PLT (3) | Neg | 0/6 | PR | CR* | DOD |
| 0A | 50, M | 15.9 | A, BM, B, L |
UH/ non | Yes | - | Pos | ND | MR | PR | DOD |
| 0A | 20, F | 10 | A, BM, B, L |
UH/ non | Yes | PLT (2, 3) | Neg | ND | SD | PR | DOD |
| 0A | 29, F | 12.9 | A, BM, B |
FH/ non | Yes | - | Neg | ND | PR | CR | CCR |
| 0A | 35, M | 13.5 | A, BM, B |
UH/ amp | Yes | PLT (3) | Neg | 0/3 | PR | PR | CCR |
| 0A | 25, M | 14 | RP, LN | UH/ ND | Yes | PLT (2, 3) | Neg | ND | PR | VGPR | CCR |
| 0A | 36, M | 14.5 | A, BM, B |
UH/ND | Yes | - | Pos | ND | PR | VGPR | DOD |
| 0A | 46, F | 13.7 | A, BM, B,LN |
UH/ ND | Yes | - | Pos | 0/1 | PR | PR | CCR |
A= adrenal primary, C= celiac primary, RP=retroperitoneal primary, BM= bone marrow, B= bone, LN= lymph node, FH= favorable Shimada histology, UH= unfavorable Shimada histology, amp = amplified MYCN, non= non-amplified MYCN, PLT = dose limiting toxicity of plateletrecovery, PBSC= dose limiting toxicity of inadequate PBSC collection, DOD = dead of disease, DOT= dead of toxicity, N/A= not applicable, ND= not done.
*
patients not evaluated for response until after surgery for local control
+
patient died of toxicity (pneumonia) during non protocol BMT one month after completing protocol therapy.