Clinical characteristics of patients with detection of PATA and absence of disease progression
| Clinical characteristics of patients without progression | Patient #: disease at enrollment | Hu14.18K322A dose (mg/m2/dose); number of courses | Best response | Months without progression |
| #12: elevated urine HVA, non-MIBG avid CT, N-MYC indeterminate (class 2 disease burden). | 6; 4 courses | SD (CT stable, VMA/HVA normal) | >63 | |
| #19: elevated VMA/HVA, 1 MIBG+ site, no N-MYC amplification (class 2 disease burden). | 20; 4 courses | SD (persistent MIBG+ site, VMA/HVA normal) | >61 | |
| #20: 1 MIBG+ site, no N-MYC amplification (class 2 disease burden). | 20; 4 courses | CR (after 2 courses) | >52 | |
| #31: 1 MIBG+ site, positive for N-MYC amplification (class 2 disease burden) | 60; 9 courses | CR (after 6 courses, recurrence at previously MIBG+ site after 37 months) | >31 | |
| Clinical response and PATA status interaction | Disease state after 2.5 years | PATA− (n=29) | PATA+ (n=9) | P value |
| Disease progression | 29 | 5 | 0.002 | |
| No progression | 0 | 4 | ||
| Clinical response and PATA status/disease burden interaction | PATA status and disease burden | Progression (n=34) | No progression (n=4) | P value |
| PATA+ and low disease burden (class 1 or 2) | 0 | 4 | 0.001 | |
| PATA− or high disease burden (class 3 or 4) | 34 | 0 |
Clinical data for each of the four patients without progression are provided in the ‘Clinical characteristics of patients without progression’ section. Correlations of PATA status (PATA+ vs. PATA−) with disease state (progression vs. no progression) are found in the ‘Clinical response and PATA status interaction’ section. Finally, correlations of PATA status and disease burden with disease status are found in the ‘Clinical response and PATA status/disease burden interaction’ section.
CR, complete remission; CT, Computed Tomography Scan; HVA, homovanillic acid; MIBG, 131I -metaiodobenzylguanidine; N-MYC, Proto-oncogene; PATA, pre-existing antitherapeutic antibodies; SD, stable disease; VMA, vanillylmandelic acid.