Table 1. Effect of alterations in PIK3CA, TP53 and receptor tyrosine kinase (RTK) signaling pathway genes on progression-free survival (PFS) in patients receiving ribociclib or placebo in combination with letrozole.
| PIK3CA | ||||
|---|---|---|---|---|
| Wild type | Altered | |||
| Ribociclib + Letrozole (n=143) | Placebo + Letrozole (n=142) | Ribociclib + Letrozole (n=69) | Placebo + Letrozole (n=73) | |
| PFS events, n | 54 | 93 | 40 | 55 |
| Median PFS, months (95% CI) | 29.6 (24.84-NR) | 14.69 (13.04-19.15) | 19.15 (13.01-23.85) | 12.71 (9.23-14.98) |
| Hazard ratio (95% CI) | 0.44 (0.31-0.62) | 0.53 (0.35-0.81) | ||
| TP53 | ||||
| Wild type | Altered | |||
| Ribociclib + Letrozole (n=180) | Placebo + Letrozole (n=194) | Ribociclib + Letrozole (n=32) | Placebo + Letrozole (n=21) | |
| PFS events, n | 72 | 129 | 22 | 19 |
| Median PFS, months (95% CI) | 27.63 (24.61-30.92) | 14.69 (13.04-16.72) | 10.22 (5.39-22.14) | 5.52 (1.84-7.39) |
| Hazard ratio (95% CI) | 0.44 (0.33-0.59) | 0.43 (0.23-0.83) | ||
| RTK signaling pathway genes | ||||
| Wild type | Altered | |||
| Ribociclib + Letrozole (n=189) | Placebo + Letrozole (n=187) | Ribociclib + Letrozole (n=23) | Placebo + Letrozole (n=28) | |
| PFS events, n | 81 | 128 | 13 | 20 |
| Median PFS, months (95% CI) | 24.84 (22.21-30.92) | 14.39 (12.85-16.46) | 21.29 (5.52-NR) | 11.43 (9.07-19.15) |
| Hazard ratio (95% CI) | 0.46 (0.35-0.62) | 0.73 (0.35-1.54) | ||
Abbreviations
1) PFS: Progression-Free Survival
2) CI: Confidence Interval
3) RTK: Receptor Tyrosine Kinase