Table 2:
Baseline Disease Characteristics, SOLAR-1 (7)
| PIK3CA mutant tumors | PIK3CA non-mutant tumors | |||||
|---|---|---|---|---|---|---|
| Alpelisib + fulvestrant | Placebo + fulvestrant | All patients | Alpelisib + fulvestrant | Placebo + fulvestrant | All patients | |
| N = 169 (%) | N = 172 (%) | N = 341 (%) | N = 115 (%) | N = 116 (%) | N = 231 (%) | |
| Sites of metastases | ||||||
| Breast | 1 (1) | 3 (2) | 4 (1) | 5 (4) | 4 (3) | 9 (4) |
| Bone | ||||||
| Any | 131 (78) | 121 (70) | 252 (74) | 79 (69) | 89 (77) | 168 (73) |
| Only | 42 (25) | 35 (20) | 77 (23) | 26 (23) | 23 (20) | 49 (21) |
| Visceral | ||||||
| Any | 93 (55) | 100 (58) | 193 (57) | 66 (57) | 74 (64) | 140 (61) |
| Liver | 49 (29) | 54 (31) | 103 (30) | 41 (36) | 36 (31) | 77 (33) |
| Lung | 57 (34) | 68 (40) | 125 (37) | 37 (32) | 55 (47) | 92 (40) |
| Number of metastatic sites | ||||||
| 0 | 0 | 1 (1) | 1 (<1) | 0 | 0 | 0 |
| 1 | 63 (37) | 52 (30) | 115 (34) | 44 (38) | 33 (29) | 77 (33) |
| 2 | 58 (34) | 60 (35) | 118 (35) | 35 (30) | 38 (33) | 73 (32) |
| ≥3 | 48 (28) | 59 (34) | 107 (31) | 36 (31) | 45 (39) | 81 (35) |
| Prior treatment | ||||||
| Any CDK 4/6 inhibitor | 9 (5) | 11 (6) | 20 (6) | 7 (6) | 8 (7) | 15 (7) |
| Tamoxifen | 59 (35) | 62 (36) | 121 (36) | 37 (32) | 50 (43) | 87 (37) |
| Chemotherapy | 101 (60) | 107 (62) | 208 (61) | 78 (68) | 72 (62) | 150 (65) |
| Neoadjuvant | 25 (15) | 29 (17) | 54 (16) | 20 (17) | 23 (20) | 43 (19) |
| Adjuvant | 78 (42) | 86 (50) | 164 (48) | 64 (56) | 58 (50) | 122 (53) |
| Line of treatment in advanced disease | ||||||
| First line | 88 (52) | 89 (52) | 177 (52) | 72 (63) | 61 (53) | 133 (58) |
| Second line | 79 (47) | 82 (48) | 161 (47) | 44 (38) | 52 (45) | 96 (42) |
| Endocrine status | ||||||
| Primary resistance | 23 (14) | 22 (13) | 45 (13) | 31 (27) | 26 (22) | 57 (25) |
| Secondary resistance | 120 (71) | 127 (74) | 247 (72) | 66 (57) | 65 (56) | 131 (57) |
| Sensitive | 20 (12) | 19 (11) | 39 (11) | 16 (14) | 20 (17) | 36 (16) |
Percentages in the table for each category may not sum to 100% due to rounding