TABLE 2.
NeuroBlate (Monteris Medical) Parameters and Their Relationship to Different Outcomes in Univariate Analysis
| Factor | PFS | DSPFS | OS | DSOS | |||||
|---|---|---|---|---|---|---|---|---|---|
| No (%) or median (range) | Median (mo) | P*a | Subhazard ratio (95% C.I) | P*b | Median (mo) | P*a | Subhazard ratio (95% C.I) | P*b | |
| Residual volume by blue TDT-line (cont.) | 0.47 cm3 (0-13.18) | .007 | 1.25 (1.1-1.3) | .0001 | .97 | 1.15 (0.9-1.3) | .06 | ||
| ≤ 0.025 cm3 | 7 (29%) | 10.7 | .01 | 4.37 (1.3-13.7) | .01 | 11.8 | .54 | 2.19 (0.6-7.5) | .21 |
| > 0.025 cm3 | 17 (71%) | 3.8 | 15.2 | ||||||
| Extent of coverage by blue TDT-line (cont.) | 95% (46-100%) | .002 | <0.01 (0.01-0.07) | .0001 | .96 | .371 (0.04-3.8) | .41 | ||
| ≤ 90% | 8 (33%) | 3.3 | .003 | 0.37 (0.1-1.1) | .07 | 14.4 | .37 | 0.52 (0.1-1.6) | .25 |
| > 90% | 16 (67%) | 5.5 | 15.2 | ||||||
| Residual volume by yellow TDT-line (cont.) | 0.09 cm3 (0-6.86) | .01 | 1.50 (1.2-1.8) | .0001 | .84 | 1.15 (0.9-1.5) | .31 | ||
| < 0.05 cm3 | 12 (50%) | 6.0 | .005 | 2.28 (0.9-5.7) | .08 | 15.2 | .45 | 1.26 (0.4-3.5) | .66 |
| ≥ 0.05 cm3 | 12 (50%) | 3.3 | 14.4 | ||||||
| Extent of coverage by yellow TDT-line (cont.) | 99% (59-100%) | .004 | 0.01 (0.01-0.4) | .02 | .94 | 0.55 (0.04-8.7) | .67 | ||
| ≤ 98% | 10 (42%) | 3.3 | .008 | 0.33 (0.1-0.8) | .02 | 14.4 | .74 | 0.63 (0.2-1.9) | .40 |
| > 98% | 14 (58%) | 5.5 | 15.2 | ||||||
| Tumor volume in blue- yellow transitional zone (cont.) | 0.38 cm3 (0-6.32) | .008 | 1.56 (1.2-1.9) | .0002 | .75 | 1.32 (1.1-1.6) | .01 | ||
| ≤ 0.025 cm3 | 8 (33%) | 8.2 | .04 | 6.52 (1.9-21.8) | .002 | 10.1 | .93 | 3.08 (0.8-11.3) | .09 |
| > 0.025 cm3 | 16 (67%) | 4.0 | 15.2 | ||||||
| TDT-line risk group (cont.) | |||||||||
| Unfavorable | 7 (29%) | 3.3 | .008 | 4.15 (2.1-8.1) | .0001 | 14.4 | .81 | 0.45 (0.2-0.9) | .04 |
| Intermediate | 9 (38%) | 4.5 | 21.4 | ||||||
| Favorable | 8 (33%) | 8.2 | 10.1 | ||||||
PFS: progression-free survival, DSPFS: disease specific progression-free survival, OS: overall survival, DSOS: disease specific overall survival, C.I: confidence interval, TDT-line: thermal damage threshold line
aLog rank test if 2 categories, Wald test from proportional hazards model if >2 categories or if the factor is measured on a continuum
bGray's test. The first group listed is the reference; ratios >1 indicate the risk of death is greater in the second group; ratios <1 that it is less. For factors measured factors or factors with >2 categories the hazard ratio represents the change in risk for a one unit (category) increment
*P value in front of major heading represents comparison across continuous variable and p value in front of subheadings represent comparison across the subgroups as categorical variable.
Bold and italics: significant