Table 1 Clinical and tumor characteristics in patients enrolled in the BOLERO-2 and SOLAR-1 trials (cohort of PIK3CA-mutated cancers)
Patient/tumor characteristic | Everolimus and exemestane group (N = 485) | Placebo and exemestane group (N = 239) | Alpelisib and fulvestrant group (N = 169) | Placebo and fulvestrant group (N = 172) |
|---|---|---|---|---|
Age (years) | ||||
Median | 62 | 61 | 63 | 64 |
Range | 34–93 | 28–90 | 25–87 | 38–92 |
ECOG Performance Statusa (%) | ||||
0 | 60 | 59 | 66.3 | 65.7 |
1 | 36 | 35 | 33.1 | 33.7 |
2 | 2 | 3 | 0 | 0 |
Missing data | NA | NA | 0.6 | 0.6 |
Visceral disease (%) | 56 | 56 | 55 | 58.1 |
Metastatic site (%) | ||||
Lung | 29 | 33 | 33.7 | 39.5 |
Liver | 33 | 30 | 29 | 31.4 |
Bone | 76 | 77 | NA | NA |
No. of metastatic sites (%) | ||||
0–1 | 32 | 29 | 37.3 | 30.2 |
2 | 31 | 34 | 34.3 | 34.9 |
≥ 3 | 36 | 37 | 28.4 | 34.3 |
Previous chemotherapy (%) | ||||
Neoadjuvant or adjuvant only | 44 | 40 | 59.8 | 62.2 |
Treatment of metastatic disease (with or without neoadjuvant or adjuvant therapy) | 26 | 26 | 0 | 0.6 |
Previous CDK 4/6 inhibitorsb (%) | 0 | 0 | 5.3 | 6.4 |