Table 4.
Survival outcomes stratified by post-HDIL-2 treatment with VEGFR-TKI or mTORi and response to HDIL-2: 2-month landmark analysis
| Best response and survival outcomes from HDIL-2 | Median OS (months) | HR (95 % CI) | p value* |
|---|---|---|---|
| No VEGFR-TKI or mTORi post-HDIL-2, n = 204 | 24.9 | ||
| Objective response to HDIL-2 | |||
| Yes versus No | 103.7 versus 19.5 | 0.18 (0.10–0.30) | <0.0001 |
| Clinical benefit to HDIL-2 | |||
| Yes versus No | 38.4 versus 12.2 | 0.27 (0.19–0.40) | <0.0001 |
| Best response to HDIL-2 | |||
| CR versus PR | 156.7 versus 34.2 | 0.17 (0.06–0.45) | 0.0004 |
| CR versus SD | 156.7 versus 24.1 | 0.13 (0.05–0.28) | <0.0001 |
| CR versus PD/NE | 156.7 versus 12.2 | 0.06 (0.02–0.13) | <0.0001 |
| PR versus SD | 34.2 versus 24.1 | 0.76 (0.36–1.44) | 0.43 |
| PR versus PD/NE | 34.2 versus 12.2 | 0.35 (0.17–0.66) | 0.0008 |
| SD versus PD/NE | 24.1 versus 12.2 | 0.46 (0.31–0.69) | 0.0001 |
| VEGFR-TKI or mTORi post-HDIL-2, n = 81 | 53.1 | ||
| Objective response to HDIL-2 | |||
| Yes versus No | 83.5 versus 50.0 | 0.44 (0.20–0.90) | 0.0235 |
| Clinical benefit to HDIL-2 | |||
| Yes versus No | 57.4 versus 27.2 | 0.29 (0.15–0.55) | 0.0003 |
| Best response to HDIL-2 | |||
| CR versus PR | NR versus 83.5 | 0.56 (0.03–3.07) | 0.55 |
| CR versus SD | NR versus 57.4 | 0.36 (0.02–1.75 | 0.24 |
| CR versus PD/NE | NR versus 27.2 | 0.12 (0.01–0.62) | 0.0073 |
| PR versus SD | 83.5 versus 57.4 | 0.64 (0.26–1.41) | 0.27 |
| PR versus PD/NE | 83.5 versus 27.2 | 0.21 (0.08–0.51) | 0.0004 |
| SD versus PD/NE | 57.4 versus 27.2 | 0.33 (0.17–0.65) | 0.0016 |
VEGFR-TKI vascular endothelial growth factor receptor–tyrosine kinase inhibitor, mTORi mammalian target of rapamycin inhibitor, and NR not reached
* Log-rank