Table 3:
Cohort 2 Bridge Therapy and Disease Response from End-Induction to End-of-Bridge Therapy
| Bridge Therapy | Pt (n) | Number of Bridge Treatment Cycles (n) |
End-Induction Overall INRC Response (n) |
End-of- Bridge Overall INRC Response (n) |
End-of-Bridge Primary Tumor Response (n) |
End-of- Bridge Metastatic Bone and Soft Tissue Response (n) |
End-of- Bridge Bone Marrow Response (n) |
Event Y/N |
Death Y/N |
|---|---|---|---|---|---|---|---|---|---|
| DIT alone | 20 | 1–6 | CR: 0 PR: 7 MR: 10 SD: 3 |
CR: 7 PR: 10 MR: 3 SD: 0 |
CR: 13 PR: 4 SD: 2 1NE 1 2Unknown: 0 |
CR: 8 PR: 11 SD: 1 1NE: 0 2Unknown: 0 |
CR: 17 PR: 2 MD: 0 SD: 0 1NE: 1 2Unknown: 0 |
7/13 | 3/17 |
| DIT followed by surgery | 1 | 10 | SD: 1 | PR: 1 | CR: 1 | PR: 1 | CR: 1 | 1/0 | 0/1 |
| ICE followed by DIT | 1 | ICE: 2 DIT: 5 |
MR: 1 | CR: 1 | CR: 1 | CR: 1 | CR: 1 | 0/1 | 0/1 |
| MIBG Alone | 12 | MIBG: 1 (n=10) 2 (n=2) |
CR: 0 PR: 6 MR: 4 SD: 2 |
CR: 1 PR: 7 MR: 4 SD: 0 |
CR: 7 PR: 4 SD: 1 1NE: 0 2Unknown: 0 |
CR: 2 PR: 8 SD: 1 1NE: 1 2Unknown: 0 |
CR: 4 PR: 3 MD: 3 SD: 0 1NE: 2 2Unknown:0 |
7/5 | 5/7 |
| MIBG followed by DIT | 2 | MIBG: 1 (n=2) DIT: 5 (n=1) 3 (n=1) |
SD: 2 | CR: 1 PR: 1 |
CR: 2 | CR: 1 PR: 1 |
CR: 2 | 0/2 | 0/2 |
| I/T followed by MIBG | 4 | I/T: 1–6 MIBG : 2 (n=1) 1 (n=3) |
CR: 0 PR: 0 MR: 3 SD: 1 |
CR: 0 PR: 3 MR: 1 SD: 0 |
CR: 4 PR: 0 SD:0 1NE:0 2Unknown: 0 |
CR: 0 PR: 3 SD: 1 1NE:0 2Unknown: 0 |
CR: 2 PR: 1 MD: 1 SD: 0 1NE: 0 2Unknown: 0 |
2/2 | 2/2 |
| I + Bortezomib followed by MIBG | 1 | MIBG: 1 | MR: 1 | PR: 1 | CR: 1 | PR: 1 | CR: 1 | 1/0 | 0/1 |
| I/T followed by MIBG plus I/V | 1 | IT: 1 MIBG + I/V: 1 |
MR: 1 | PR: 1 | CR: 1 | PR: 1 | CR: 1 | 1/0 | 0/1 |
| Surgery and MIBG | 2 | MIBG: 1 (n=2) |
CR: 0 PR: 1 MR: 0 SD: 1 |
CR: 0 PR: 1 MR: 1 SD: 0 |
CR: 0 PR: 2 SD:0 1NE:0 2Unknown: 0 |
CR: 0 PR: 1 SD: 1 1NE:0 2Unknown: 0 |
CR: 0 PR: 2 MD:0 SD:0 1NE:0 2Unknown: 0 |
2/0 | 1/1 |
| Cyclo/ Topo |
3 | 2 (n=1) 1 (n=1) Unknown (n=1) |
CR: 0 PR: 3 MR: 0 SD: 0 |
CR: 1 PR: 1 MR: 0 SD: 0 2Unknown:1 |
CR: 2 PR: 0 SD: 0 1NE: 0 2Unknown: 1 |
CR: 2 PR: 0 SD: 0 1NE: 0 2Unknown: 1 |
CR: 1 PR: 1 MD: 0 SD: 0 1NE: 0 2Unknown: 1 |
1/2 | 1/2 |
| ICE followed by Cyclo/ Topo and surgery |
1 | ICE: 2 Cyclo/Topo: 2 |
MR: 1 | SD: 1 | CR: 1 | SD: 1 | CR: 1 | 0/1 | 0/1 |
| Cixutumu-mab and Temsiro-limus (ADVL1221) followed by surgery | 1 | 1 | MR: 1 | CR: 1 | CR: 1 | CR: 1 | CR: 1 | 1/0 | 1/0 |
| I/T followed by surgery | 1 | 1 | MR: 1 | MR: 1 | PR: 1 | SD: 1 | MR: 1 | 1/0 | 1/0 |
| External Beam Radiation |
1 | NA | PR: 1 | PR: 1 | PR: 1 | CR: 1 | PR: 1 | 0/1 | 0/1 |
Abbreviations: CR, complete response; Cyclo/Topo, cyclophosphamide and topotecan; DIT, dinutuximab, irinotecan, and temozolomide; ICE, ifosfamide, carboplatin, and etoposide; I, irinotecan; INRC, International Neuroblastoma Response Criteria; I/T, irinotecan and temozolomide; I/V, irinotecan and vincristine; MD, minimal disease; MIBG, meta-iodobenzylguanidine; MR, minor response; NA, not applicable; NE, not evaluable; PR, partial response; SD, stable disease; Y/N, yes/no.
1
Response not evaluable; site not involved at diagnosis and remains uninvolved
2
Unknown response of evaluable disease