Table 1. Clinical and biological characteristics.
ASCT Status | ||||
---|---|---|---|---|
All Patients | Yes (n = 60) | No (n = 110) | p-value | |
Gender | ||||
Female | 62 (36) | 20 (33) | 42 (38) | 0.6177 |
Male | 108 (74) | 40 (67) | 68 (62) | |
Stage 4a | 159 (94) | 55 (92) | 104 (95) | 0.687 |
Age at diagnosis (months) | 34.1 (0–179.3)b | 33.4 (5.5–90.1) | 36.2 (0–179.3) | 0.6598 |
MYCN | ||||
Not Amplified | 76 (45) | 22 (37) | 54 (49) | 0.1865 |
Amplified | 86 (51) | 34 (57) | 52 (47) | |
Time from 1st chemo to 3F8 | 7.7 (3.1–23.6)b | 8.5 (6.4–17.2) | 6.1 (3.1–23.6) | < 0.001 |
Time from ASCT/last chemo to 3F8 | 1.5 (0.8–7.5)b | 2.3 (1.2–7.5) | 1.3 (0.8–5.4) | < 0.001 |
Induction regimens | ||||
Children's Oncology Group1–3 | 149 (87) | 48 (80) | 101 (92) | 0.078 |
Limited institutional36, 37 | 13 (8) | 8 (13) | 5 (5) | |
European26, 27 | 8 (5) | 4 (7) | 4 (4) | |
Ultra-High-Riskc | ||||
No | 115 (68) | 47 (78) | 68 (62) | 0.039 |
Yes | 55 (32) | 13 (22) | 42 (38) | |
High-Dose 3F8 | ||||
No | 148 (87) | 58 (97) | 90 (82) | 0.0072 |
Yes | 22 (13) | 2 (3) | 20 (18) | |
MRD at study entry (pre-MRD) | ||||
Negative | 119 (70) | 40 (67) | 79 (72) | 0.4892 |
Positive | 51 (30) | 20 (33) | 31 (28) | |
MRD after 2 cycles (post-MRD) | ||||
Negative | 144 (85) | 50 (83) | 94 (85) | 0.4581 |
Positive | 21 (12) | 5 (8) | 16 (15) | |
HAMA | ||||
No | 38 (22) | 11 (18) | 27 (25) | 0.442 |
Yes | 132 (78) | 49 (82) | 83 (75) | |
FcGR2a | ||||
HH | 47 (28) | 16 (27) | 31 (28) | 0.9552 |
HR | 85 (50) | 31 (52) | 54 (49) | |
RR | 38 (22) | 13 (22) | 25 (23) | |
FcGR3a | ||||
FF | 24 (14) | 5 (8) | 19 (17) | 0.1752 |
VF | 85 (50) | 35 (58) | 50 (45) | |
VV | 61 (36) | 20 (33) | 41 (37) | |
KIR 2DL1 missing ligand | ||||
No | 91 (54) | 30 (50) | 61 (55) | 0.523 |
Yes | 79 (46) | 30 (50) | 49 (45) | |
KIR 2DL2 2DL3 missing ligand | ||||
No | 151 (89) | 55 (92) | 96 (87) | 0.4539 |
Yes | 19 (11) | 5 (8) | 14 (13) | |
KIR 3DL1 missing ligand | ||||
No | 108 (64) | 40 (67) | 68 (62) | 0.6177 |
Yes | 62 (36) | 20 (33) | 42 (38) |
Abbreviations: ASCT, autologous stem-cell transplantation; chemo, chemotherapy; HAMA, human anti-mouse antibody; NB, neuroblastoma; MRD, minimal residual disease in bone marrow
All non-stage 4 patients had MYCN-amplified stage 3 except for one non-ASCT patient who had MYCN-amplified stage 2B.
median (range)
Because of an incomplete response to induction, 2nd-line therapy was needed to achieve 1st CR/VGPR.