Table 1.
Characteristics of patients and alpelisib-related dAEs by treatment protocol
| NCT01870505 | NCT02167854 | NCT02734615 | NCT03056755 | Post-Approval | All | |
|---|---|---|---|---|---|---|
| N (%) | 51 (50.0) | 23 (22.5) | 8 (7.8) | 11 (10.8) | 9 (8.9) | 102 (100) |
| Sex (M/F) | 0/51 | 0/23 | 0/8 | 0/11 | 2/7 | 2/100 |
| Race, white (%) | 38 (74.5) | 16 (69.6) | 8 (100.0) | 8 (72.7) | 5 (55.6) | 75 (73.5) |
| Avg Age (SEM) | 55.5 (12.1) | 53.5 (8.6) | 60.0 (13.0) | 59.0 (7.7) | 65 (4.5) | 56.2 (1.1) |
| Primary Malignancy | HR+ Breast | HER2+ Breast | HR+ Breast | HR+ Breast | HR+ Breasta Prostateb Lungc EMPDd | |
| Drugs | Alpelisib Letrozole/Exemestane | Alpelisib anti-HER3 Trastuzumab | Alpelisib SERDe | Alpelisib Fulvestrant/Letrozole | Alpelisib Fulvestrant | |
| Dosef (range) | 300 mg (200-350 mg) | 300 mg (250-350 mg) | 225 mg (200-300 mg) | 300 mg (300-300 mg) | 300 mg (200-300 mg) | |
| Any grade rash (%g) | 23 (45.1) | 8 (34.8) | 4 (50.0) | 3 (27.3) | 3 (33.3) | 41 (40.2) |
| Grade 1/2 rash (%g) | 8 (15.7) | 8 (34.8) | 4 (50.0) | 1 (9.1) | 1 (11.1) | 22 (21.6) |
| Grade 3 rash (%g) | 15 (29.4) | 0 (0.0) | 0 (0.0) | 2 (18.2) | 2 (22.2) | 19 (18.6) |
a
HR+ Breast, n=6
b
Prostate, n=1
c
Squamous Cell Carcinoma of Lung, n=1
d
Extramammary Paget’s Disease (EMPD), n=1
e
selective estrogen receptor degrader
f
median dose of alpelisib at drug initiation
g
% of patients within each protocol/column