Table 1.
Variable | Total cohort (n = 72) | Neratinib monotherapy n = 27) | Neratinib with capecitabine (n = 45) |
---|---|---|---|
n (%) | n (%) | n (%) | |
Age | |||
< 65 | 58 (81) | 19 (70) | 39 (87) |
≥ 65 | 14 (19) | 8 (30) | 6 (13) |
ECOG Performance status | |||
0 | 15 (21) | 3 (11) | 12 (27) |
1 | 49 (68) | 19 (70) | 30 (67) |
2 | 6 (8) | 3 (11) | 3 (7) |
3 | 2 (3) | 2 (7) | 0 (0) |
Cutaneous disease | |||
Yes | 14 (19) | 6 (22) | 8 (18) |
Bone | |||
Yes | 46 (64) | 17 (63) | 29 (64) |
Visceral | |||
Yes | 53 (74) | 21 (78) | 32 (71) |
Brain metastasis | |||
Yes | 38 (53) | 15 (56) | 18 (40) |
Leptomeningeal disease | |||
Yes | 7 (10) | 5 (19) | 4 (9) |
Measurable disease | |||
Yes | 63 (88) | 23 (85) | 40 (89) |
Histology | |||
IDC | 61 (85) | 25 (93) | 36 (80) |
ILC | 6 (8) | 2 (7) | 4 (9) |
Mixed IDC/ILC | 2 (3) | 0 (0) | 2 (4) |
Unknown | 3 (4) | 0 (0) | 3 (7) |
Grade | |||
1 | 2 (3) | 1 (4) | 1 (2) |
2 | 19 (26) | 8 (30) | 11 (24) |
3 | 48 (67) | 18 (67) | 40 (89) |
Unknown | 3 (4) | 0 (0) | 3 (7) |
ER status | |||
Negative | 29 (40) | 11 (41) | 18 (40) |
Positive | 42 (58) | 16 (59) | 26 (58) |
Unknown | 1 (1) | 0 (0) | 1 (2) |
ER Allred score: median (IQR), (range) | 6 (0–8), (0–8) | 7 (0–8), (0–8) | 5 (0–8), (0–8) |
PgR status | |||
Negative | 37 (51) | 12 (44) | 25 (56) |
Positive | 26 (36) | 12 (44) | 14 (31) |
Unknown | 9 (13) | 3 (11) | 6 (13) |
PgR Allred score: median (IQR), (range) | 0 (0–5), (0–8) | 1 (0–5), (0–8) | 1 (0–4), (0–8) |
HER2 status | |||
IHC3 + | 58 (81) | 22 (81) | 36 (80) |
IHC2 + /ISH+ | 11 (15) | 3 (11) | 8 (18) |
HER2 Positive but IHC unknown | 3 (4) | 2 (7) | 1 (2) |
Prior lines of treatment: median (IQR), (range) | 3 (2–4) (1–7) | 3 (3–5), (1–7) | 2 (2–3), (1–6) |
Prior anti-HER2 TKI | |||
Yes | 22 (31) | 13 (48) | 9 (20) |
Prior pertuzumab | |||
Yes | 35 (49) | 12 (44) | 23 (51) |
Prior T-DM1 | |||
Yes | 62 (86) | 24 (89) | 38 (84) |
Prior Fulvestrant | 4 (6) | 4 (15) | 0 (0) |
Prior Trastuzumab | 3(6) | 2 (7) | 1 (2) |
IDC Invasive ductal carcinoma, ILC Invasive lobular carcinoma