Table 2.
Summary of 14 patients with response ≥SD (n = 59 evaluable patients)
| TUMOR SITES AT ENTRY: |
Overall Response (site responses) |
# Courses response maintained |
|||
|---|---|---|---|---|---|
| Stratum | MIBG Score | CT longest dimension |
Bone marrow |
||
| 2 | 3 | 0 | Negative | PR | 11 |
| 2 | 11 | 0 | Positivea (< 5%) | SD (SD on MIBG; CR in BM) | 15 |
| 2 | 15 | 0 | Negative | SD | 45+b |
| 2 | 7 | 0 | Positive | SD (MIBG sites resolved, not evaluable since radiated) | 35 |
| (all sites radiated C1) | (< 5%) | (5 courses compassionate) | |||
| 1 | 1 | 4 cm | Negative | SD | 30+c |
| 1 | 1 | 5 cm | Negative | SD | 30+d |
| 1 | 25 | 10.3 cm | Negative | SD | 24 |
| 1 | 0 | 4 cm | Negative | SD | 15 |
| 2 | 11 | 0 | Negative | SD | 9 |
| 1 | 15 | 10.9 | Negative | SD | 7 |
| 2 | 1 | 0 | Positive (<5–10%) | SD (CR at MIBG avid bone site; not evaluable since radiated) | 7 |
| 2 | 11 | 0 | Positive | SD | 7 |
| (< 5%) | |||||
| 1 | 1 | 6 cm | Negative | SD | 5 |
| 1 | 2 | 8.5 cm | Negative | SD | 4 |
a
BM slides not reviewed; reports were reviewed.
b
Centrally reviewed C1-C20; 15 compassionate courses. Alive with SD & no further therapy 13 months off fenretinide.
c
Completed C30 with SD; achieved CR on compassionate fenretinide 25 months later; last confirmed 50 months post C30; alive on fenretinide 53 months post C30.
d
Post C30 given 13-cis-retinoic acid for 3 months. Alive 57 months post C30. CR= complete response, PR=partial response, SD=stable disease, PD= progressive disease, BM=bone marrow; C= course