Table 2.
Treatment comparison on PFS and OS by MVD and MCD levels (dichotomized at the upper 33% value) by treatment arm.
| CABOZANTINIB (N=175) | EVEROLIMUS (N=185) | CABOZANTINIB vs EVEROLIMUS | ||||||
|---|---|---|---|---|---|---|---|---|
| N of events/N of patients | Months, Median (95% CI) |
N of events/N of patients | Months, Median (95% CI) |
Hazard ratio-Adjusted* (C vs E) (95%CI) |
p-interaction | Hazard ratio-Unadjusted* (C vs E) (95%CI) |
p-interaction | |
| Microvascular density | ||||||||
| PFS | ||||||||
| Low (≤208.2 mm2) | 65/112 | 7.3 (5.5–7.5) | 89/128 | 3.75 (3.6 –4.5) | 0.45 (0.32–0.64) | 0.4961 | 0.47 (0.34–0.65) | 0.3639 |
| High (>208.2 mm2) | 32/63 | 8.97 (6.28-NR) | 34/57 | 7.3 (4.1–9.1) | 0.56 (0.34–0.91) | 0.62 (0.38–0.99) | ||
| Adj HR (High vs Low)* | 0.77 (.50–1.18) | 0.63 (0.42–0.95) | ||||||
| OS | ||||||||
| Low (≤208.2 mm2) | 49/112 | 20.8 (17.1-NR) | 72/128 | 16.4 (13.2– 18.9) | 0.61 (0.42–0.89) | 0.7628 | 0.69 (0.48–0.99) | 0.7745 |
| High (>208.2 mm2) | 21/63 | NR (18.2-NR) | 27/57 | 20.4 (13.9-NR) | 0.55 (0.31–0.97) | 0.62 (0.35–1.10) | ||
| Adj HR (High vs Low)* | 0.75 (.45–1.26) | 0.84 (0.54–1.31) | ||||||
| Mast cell Density | ||||||||
| PFS | ||||||||
| Low (≤11.3 mm2) | 60/102 | 7.2 (5.6–8.5) | 82/114 | 3.8 (3.6–4.7) | 0.43 (0.30–0.60) | 0.1127 | 0.44 (0.32–0.62) | 0.1121 |
| High (>11.3 mm2) | 27/57 | 7.5 (7.2-NR) | 27/52 | 7.5 (5.6–9.2) | 0.71 (0.41–1.22) | 0.74 (0.44– 1.26) | ||
| Adj. HR (High vs Low)* | 0.85 (0.54–1.34) | 0.51 (0.32–0.79) | ||||||
| OS | ||||||||
| Low (≤11.3 mm2) | 43/102 | 20.1 (17.4-NR) | 67/114 | 15.4 (11.6–18.8) | 0.52 (0.35–0.77) | 0.2406 | 0.59 (0.40– 0.87) | 0.3691 |
| High (>11.3 mm2) | 19/57 | NR (17.2-NR) | 20/52 | NR (16.2-NR) | 0.82 (0.43–1.54) | 0.83 (0.44– 1.55) | ||
| Adj. HR (High vs Low)* | 0.88 (0.51–1.52) | 0.56 (0.34–0.94) | ||||||
*
Adjusted for IMDC risk group, presence of bone metastases and number of previous VEGFR TKI treatment (1 or ≥2)