Table 2.
Univariate and Multivariate Analyses of Variables on Progression-Free Survival in 147 Patients Treated With Anti-GD2 Antibody 3F8 Plus Subcutaneous GM-CSF
| Variable | No. of Patients* |
P |
Hazard Ratio | 95% CI | |
|---|---|---|---|---|---|
| Univariate Analysis | Multivariate Analysis | ||||
| Frequency change in CBRM1/5-positive granulocytes† | 147 | .024 | .005 | 0.51 | 0.32 to 0.81 |
| MYCN amplification | 140 | .32 | — | — | — |
| Prior bone marrow or stem-cell transplantation | 147 | .12 | — | — | — |
| History of prior relapse‡ | 147 | .025 | .092 | 1.81 | 0.91 to 3.59 |
| Second-line cyclophosphamide-based regimen | 147 | .001 | .001 | 2.24 | 1.39 to 3.63 |
| Disease status at enrollment§ | 147 | .008 | .67 | 0.95 | 0.75 to 1.21 |
| Missing KIR ligand | 147 | .073 | .034 | 0.60 | 0.38 to 0.96 |
| FcGR2A polymorphism‖ | 147 | .40 | — | — | — |
Abbreviations: GM-CSF, granulocyte-macrophage colony-stimulating factor; KIR, killer immunoglobulin-like receptor.
Four secondary refractory patients were excluded from this analysis.
Frequency was defined as the percentage of granulocyte cells positive for CBRM1/5 activation marker; change was measured from day 0 to day 4 using median cut point.
History of prior relapse included all patients in second complete remission/very good partial remission.
First complete remission/very good partial remission v primary refractory v second complete remission/very good partial remission.
R/R or R/H v H/H.