Table 1. Demographic data, treatments, response and outcome.
| Pt N |
Country | Sex | Age (yrs) | Stage | 1st Line Study |
Sx | CTH | RT | HDT | 2nd Line mIBG | Rel Treat |
Ch14.18/CHO start months after Dx | INSS Status prior ch14.18/CHO | Dose level | No. courses received | Centrally reviewed mIBG response | FU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
1 |
AT |
f |
8.5 |
4 |
HRNBL1 |
yes |
yes |
yes |
yes |
yes |
n.d. |
16 |
PR |
10mg |
3 |
NE |
DOD |
|
2 |
IT |
m |
4.4 |
4 |
HRNBL1 |
yes |
yes |
yes |
yes |
yes |
n.d. |
28 |
PR |
10mg |
2 |
NE |
CR |
|
3 |
IT |
m |
13.1 |
4 |
HRNBL1 |
no |
yes |
yes |
yes |
yes |
n.d. |
34 |
PR |
10mg |
2 |
Progression |
DOD |
|
4 |
AT |
f |
6.6 |
4 |
HRNBL1 |
yes |
yes |
no |
yes |
no |
n.d. |
13 |
PR |
20mg |
3 |
Progression |
DOD |
|
5 |
AT/FR |
f |
5.3 |
4 |
HRNBL1 |
yes |
yes |
yes |
yes |
yes |
TVD |
31 |
CR |
20mg |
3 |
Continuous CR |
DOD |
|
6 |
IT |
m |
17.3 |
4 |
HRNBL1 |
no |
yes |
no |
no |
no |
TVD |
34 |
PR |
20mg |
1 |
> 90% response |
DOD |
|
7 |
AT |
f |
13.8 |
4 |
HRNBL1 |
yes |
yes |
no |
yes |
no |
n.d. |
20 |
CR |
30mg |
3 |
NE |
CR |
|
8 |
IT |
f |
10.8 |
4 |
HRNBL1 |
yes |
yes |
yes |
yes |
no |
TVD |
29 |
PR |
30mg |
3 |
Stable* |
DOD |
|
9 |
AT |
f |
3.8 |
4 |
HRNBL1 |
yes |
yes |
yes |
yes |
no |
n.d. |
15 |
PR |
30mg |
3 |
> 50% response |
CR |
|
10 |
IT |
f |
15.5 |
4 |
AIEOP NB 92 |
yes |
yes |
no |
yes |
no |
TVD |
131 |
PR |
20mg |
2 |
Stable |
DOD |
|
11 |
AT |
m |
7.4 |
4 |
HRNBL1 |
yes |
yes |
yes |
yes |
no |
TVD |
32 |
PR |
20mg |
3 |
NE |
DOD |
|
12 |
AT |
f |
5.8 |
4 |
HRNBL1 |
no |
yes |
no |
yes |
no |
n.d. |
8 |
CR |
20mg |
3 |
Continuous CR |
LTF |
|
13 |
DE |
f |
7.5 |
4 |
NB97 |
yes |
yes |
yes |
yes |
yes* |
TCE |
26 |
PR |
20mg |
3 |
NE |
DOD |
|
14 |
AT |
m |
15.3 |
2b |
NBL2000 |
yes |
yes |
no |
no |
no |
mIBG- Topo |
32 |
PR |
20mg |
3 |
Progression |
DOD |
|
15 |
IT |
m |
5.9 |
3 |
HRNBL1 |
yes |
yes |
yes |
yes |
no |
n.d. |
10 |
PR |
20mg |
2 |
NE |
CR |
|
16 |
IT |
m |
7.7 |
4 |
HRNBL1 |
yes |
yes |
no |
yes |
yes |
TVD |
8 |
PR |
20mg |
2 |
NE |
DOD |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total | 13 | 16 | 9 | 14 | 6 | 8 | 41 |
Legend: AT Austria, IT Italy, DE Germany, FR France, HRNBL1: High Risk Neuroblastoma 1 Study of the SIOPEN group; TVD: topotecan, vincristine, doxorubicin; TCE: topotecan cylophosphamide etoposide; NB97: German Pediatric Oncology-Hematology Society study trial for neuroblastoma 1997; AEIOP NB92: Assciazone Italiana Ematologica Oncologica Pediatrica Neuroblastoma Study Protocol 1992; Yrs: years; Sx:surgery, CTH: chemotherapy, RT: radiotherapy, HDT high dose therapy followed by stem cell rescue, 2nd Line mIBG: 2nd line meta-Iodobenzylguanidine treatment with and without Topotecan, Rel Treat: relapse treatment, No. courses received: number of courses received; FU follow up, Total: total number of patients having received the respective treatment modality; m: male, f: female; NE: not evaluable; CR: Complete remission, VGPR: very good partial remission, PR: partial remission; SD stable disease; PD: progressing disease; DOD: dead of disease; LTF: lost to follow-up; Cerebral metastases occurred during the third course in patients 1 and 11. Response: 2 of 7 patients reached improved disease status after immunotherapy. Median duration till start of ch14.18/CHO treatment: 27 mo (range, 8 to 131months). Mean interval was 38.9 mo/ * Response was assessed after two courses.