Table 1.
Patient characteristics at baseline
|
PIK3CA-mutant cohort N = 127 |
PIK3CA-wild-type cohort N = 130 | |||
|---|---|---|---|---|
| Characteristic | Alpelisib + letrozole n = 60 | Placebo + letrozole n = 67 |
Alpelisib + letrozole n = 71 | Placebo + letrozole n = 59 |
| Age, median (range), years | 65.5 (47–86) | 61.0 (37–82) | 63.0 (50–84) | 64.0 (49–84) |
| Race, n (%) | ||||
| White | 53 (88.3) | 51 (76.1) | 64 (90.1) | 54 (91.5) |
| Asian | 5 (8.3) | 9 (13.4) | 2 (2.8) | 1 (1.7) |
| Black or African American | 1 (1.7) | 2 (3.0) | 2 (2.8) | 3 (5.1) |
| Unknown | 1 (1.7) | 2 (3.0) | 0 | 1 (1.7) |
| Other | 0 | 3 (4.5) | 3 (4.2) | 0 |
| ECOG performance status, n (%) | ||||
| 0 | 56 (93.3) | 62 (92.5) | 66 (93.0) | 54 (91.5) |
| 1 | 4 (6.7) | 5 (7.5) | 5 (7.0) | 5 (8.5) |
| Hormone receptor status, n (%) | ||||
| Estrogen receptor-positive | 60 (100) | 67 (100) | 70 (98.6) | 59 (100) |
| Progesterone receptor-positive | 48 (80.0) | 60 (89.6) | 65 (91.5) | 48 (81.4) |
| Both positive | 48 (80.0) | 60 (89.6) | 64 (90.1) | 48 (81.4) |
| Details of tumor histology/cytology, n (%) | ||||
| Adenocarcinoma | 1 (1.7) | 2 (3.0) | 1 (1.4) | 2 (3.4) |
| Breast lobular invasive | 14 (23.3) | 13 (19.4) | 19 (26.8) | 8 (13.6) |
| Ductal invasive carcinoma | 41 (68.3) | 49 (73.1) | 49 (69.0) | 45 (76.3) |
| Other | 4 (6.7) | 3 (4.5) | 2 (2.8) | 4 (6.8) |
| Histologic grade, n (%) | ||||
| Well differentiated | 17 (28.3) | 22 (32.8) | 13 (18.3) | 13 (22.0) |
| Moderately differentiated | 30 (50.0) | 30 (44.8) | 37 (52.1) | 33 (55.9) |
| Poorly differentiated | 9 (15.0) | 8 (11.9) | 15 (21.1) | 8 (13.6) |
| Other | 4 (6.7) | 7 (10.4) | 6 (8.5) | 5 (8.5) |
| Primary tumor stage at study entry, n (%) | ||||
| T1b | 0 | 0 | 1 (1.4) | 0 |
| T1c | 19 (31.7) | 16 (23.9) | 18 (25.4) | 15 (25.4) |
| T2 | 34 (56.7) | 51 (76.1) | 39 (54.9) | 37 (62.7) |
| T3 | 7 (11.7) | 0 | 13 (18.3) | 7 (11.9) |
| Lymph node stage at study entry, n (%) | ||||
| N0 | 39 (65.0) | 49 (73.1) | 47 (66.2) | 36 (61.0) |
| N1 | 17 (28.3) | 17 (25.4) | 19 (26.8) | 19 (32.2) |
| N2 | 3 (5.0) | 0 | 4 (5.6) | 2 (3.4) |
| N3 | 1 (1.7) | 1 (1.5) | 1 (1.4) | 2 (3.4) |
| Time since initial diagnosis of primary site, median (range) months | 1.5 (0.6–5.9) | 1.5 (0.8–7.5) | 1.5 (0.7–49.3) | 1.4 (0.8–4.1) |
| Type of lesions at baseline, n (%) | ||||
| Target only | 45 (75.0) | 54 (80.6) | 51 (71.8) | 40 (67.8) |
| Both target and nontarget | 15 (25.0) | 12 (17.9) | 20 (28.2) | 19 (32.2) |
| Unknown | 0 | 1 (1.5) | 0 | 0 |
| Multicentric disease, n (%) | 3 (5.0) | 8 (11.9) | 5 (7.0) | 5 (8.5) |
Abbreviation: ECOG, Eastern Cooperative Oncology Group.