Table 1.
Xenograft (histology) | Chemotherapy group | KM estimate median time to event (days)a | p valueb | EFS T/C (days)c | Median RTV at end of studyd | Tumor volume T/C (cm3)e | p valuef | Median group response |
---|---|---|---|---|---|---|---|---|
KT-51 (UH) | V | 17.36 | 0.282 | 1.3 | 99.00 | 0.68 | 0.005 | PD1 |
KT-51 (UH) | A | 11.98 | 0.126 | 0.9 | 99.00 | 1.38 | 0.038 | PD1 |
KT-51 (UH) | D | 14.12 | 0.501 | 1.0 | 99.00 | 1.31 | 0.195 | PD1 |
KT-51 (UH) | VA | 17.05 | 0.394 | 1.2 | 11.19 | 1.42 | 0.072 | PD1 |
KT-51 (UH) | VAD | 21.54 | 0.073 | 1.6 | 58.74 | 0.56 | 0.005 | PD1 |
KT-53 (UH) | V | 49.55 | <0.001 | 4.1 | >10 | 0.02 | <0.001 | CR |
KT-53 (UH) | A | 12.31 | 0.192 | 1.0 | >10 | 0.89 | 0.234 | PD1 |
KT-53 (UH) | D | 12.01 | 0.853 | 1.0 | >10 | 0.80 | 0.040 | PD1 |
KT-53 (UH) | VA | 39.02 | <0.001 | 3.2 | >10 | 0.04 | <0.001 | PD2 |
KT-53 (UH) | VAD | 40.05 | 0.006 | 3.3 | >10 | 0.05 | 0.012 | PD2 |
KT-43 (FH) | V | – | 0.002 | >3.8 | 8.9649 | 0.15 | 0.002 | CR |
KT-43 (FH) | A | 24.20 | 0.997 | 1.1 | 16.4177 | 1.24 | 0.876 | PD1 |
KT-43 (FH) | D | – | – | – | – | – | – | – |
KT-43 (FH) | VA | – | 0.002 | >3.8 | 54.6278 | 0.21 | 0.017 | CR |
KT-43 (FH) | VAD | – | 0.002 | >3.8 | 1.9462 | 0.09 | 0.008 | CR |
KT-45 (FH) | V | – | 0.001 | >3.4 | 0 | 0.00 | <0.001 | MCR |
KT-45 (FH) | A | – | 0.001 | >3.4 | 0.5257 | 0.02 | <0.001 | CR |
KT-45 (FH) | D | 47.23 | 0.004 | 1.9 | 99 | 0.29 | <0.001 | PD2 |
KT-45 (FH) | VA | – | 0.001 | >3.4 | 0 | 0.00 | <0.001 | MCR |
KT-45 (FH) | VAD | – | 0.001 | >3.3 | 0 | 0.00 | <0.001 | MCR |
KT-47 (FH) | V | >EP | <0.001 | >4.9 | 0.39 | 0.01 | <0.001 | MCR |
KT-47 (FH) | A | 41.43 | <0.001 | 2.4 | >10 | 0.16 | <0.001 | PR |
KT-47 (FH) | D | 24.80 | <0.001 | 1.5 | >10 | 0.21 | <0.001 | PD1 |
KT-47 (FH) | VA | >EP | 0.002 | >5.0 | 0.20 | 0.01 | 0.004 | MCR |
KT-47 (FH) | VAD | >EP | <0.001 | >4.9 | 0.24 | 0.01 | <0.001 | CR |
KT-75 (FH) | V | – | <0.001 | >4.7 | 0 | 0.00 | <0.001 | MCR |
KT-75 (FH) | A | 29.60 | <0.001 | 1.6 | 99 | 0.28 | <0.001 | PD1 |
KT-75 (FH) | D | – | – | – | – | – | – | – |
KT-75 (FH) | VA | – | <0.001 | >4.7 | 0 | 0.00 | <0.001 | MCR |
KT-75 (FH) | VAD | – | <0.001 | >4.7 | 0 | 0.00 | 0.001 | MCR |
PD1—progressive disease 1 (>25% increase in tumor volume with tumor growth delay value ≤ 1.5)
PD2—progressive disease 2 (>25% increase in tumor volume with tumor growth delay value > 1.5)
CR—complete response—disappearance of measurable tumor mass (<0.10 cm3) for at least one time point
MCR—maintained complete response—tumor mass <0.10 cm3 at end of study period
PR—partial response—tumor volume regression of ≥50% for at least one time point but with measurable tumor (≥0.10 cm3)
FH favorable histology, UH unfavorable histology (diffuse anaplasia), V vincristine, A actinomycin-D, D doxorubicin, VA vincristine + actinomycin-D, VAD vincristine + actinomycin-D + doxorubicin, EP evaluation period, EFS event-free survival, KM Kaplan–Meier, RTV relative tumor volume
aKaplan–Meier estimate of median days to event was determined by using interpolated days to event. >EP indicates that median event free survival for the treated group is greater than the evaluation period (EP)
bExact log-rank test p values comparing event free survival distributions between treated and control groups
cEFS T/C: ratio of the median time to event between treated and control groups
dMedian final RTV is the ratio of tumor volume at the end of treatment to that at initiation of treatment
eTumor volume T/C is the ratio of mean tumor volume of treated tumors divided by that of control tumors
fWilcoxon rank sum test p values comparing tumor volumes between control and treated groups