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. 2018 Dec 13;5(2):e184475. doi: 10.1001/jamaoncol.2018.4475

Table 1. Patient Characteristics at Baseline.

Characteristic Alpelisib Dose Level Plus Fulvestrant, 500 mg
300 mg Once Daily (n = 9) 350 mg Once Daily (n = 8) 400 mg Once Daily (n = 70) All Patients (N = 87)
Age, median (range), y 56 (39-73) 55 (43-65) 59 (37-79) 58 (37-79)
ECOG performance status, No. (%)
0 4 (44) 3 (38) 32 (46) 39 (45)
1 5 (56) 5 (63) 36 (51) 46 (53)
2 0 0 1 (1) 1 (1)
Missing 0 0 1 (1) 1 (1)
Breast cancer stage at initial diagnosis, No. (%)
0 0 0 1 (1) 1 (1)
I/Ia 2 (22) 2 (25) 7 (10) 11 (13)
II/IIa/IIb/IIc 2 (22) 1 (13) 29 (41) 32 (37)
III/IIIa/IIIb/IIIc 0 1 (13) 11 (16) 12 (14)
IV 4 (44) 1 (13) 18 (26) 23 (26)
Missing 1 (11) 3 (38) 4 (6) 8 (9)
No. of metastatic sites, median (range) 3 (1-5) 3 (1-5) 3 (1-8) 3 (1-8)
Time between initial diagnosis and study treatment initiation, median (range), mo 62 (9-176) 106 (20-292) 94 (12-349) 93 (9-349)
No. of prior antineoplastic therapies, median (range) 6 (1-11) 5 (2-7) 5 (1-16) 5 (1-16)
Prior mTOR inhibitor, No. (%) 1 (11) 2 (25) 18 (26) 21 (24)
Prior fulvestrant, No. (%) 5 (56) 6 (75) 28 (40) 39 (45)
Prior chemotherapy, No. (%) 7 (78) 6 (75) 66 (94) 79 (91)
Locally assessed PIK3CA status, No. (%)
Altered (mutation/amplification) 9 (100) 8 (100) 35 (50) 52 (60)
Wild type 0 0 33 (47) 33 (38)
Unknown 0 0 2 (3) 2 (2)

Abbreviations: ECOG, Eastern Cooperative Oncology Group; mTOR, mammalian target of rapamycin.