Table 1 Demographics and baseline characteristics (ITT population)
Parameter | Letrozole + Dasatinib (n = 57 (%)) | Letrozole (n = 63 (%)) | |
|---|---|---|---|
Age, years (range) | Median | 62.3 (37.4, 80.9) | 61.3 (35.6, 86.9) |
DFI in Recurrent Metastatic Patients | |||
<=2 years | 27 (47) | 34 (54) | |
>2 years | 30 (53) | 29 (46) | |
Median (Range) in months | 27.5 (0, 277) | 21.2 (0, 290) | |
De Novo stage IV | 24 (42) | 20 (32) | |
ECOG performance status | 0 | 33 (58) | 40 (64) |
1 | 24 (42) | 22 (35) | |
2 | 0 | 1 (2) | |
Histological grade | G1 | 8 (14) | 6 (10) |
G2 | 22 (39) | 28 (44) | |
G3 | 17 (30) | 14 (22) | |
GX (Grade cannot be assessed) | 0 | 5 (8) | |
Unknown | 10 (18) | 10 (16) | |
Sites of metastasis | Bone | 42 (74) | 44 (70) |
Lymph node/soft tissue | 18 (32) | 18 (29) | |
Visceral-liver | 10 (18) | 12 (19) | |
Visceral-lung | 8 (14) | 10 (16) | |
Assessment type (evaluable population) | Measurable by RECIST | 34 (60) | 46 (73) |
Not measurable | 22 (39) | 15 (24) | |
Missing | 1 (2) | 2 (3) | |
Prior chemotherapy | Yes | 26 (46) | 33 (52) |
Adjuvant | 22 (39) | 30 (48) | |
Metastatic | 6 (11) | 3 (5) | |
No | 31 (54) | 29 (46) | |
Unknown | 0 | 1 (2) | |
Prior endocrine therapy | Yes | 22 (39) | 32 (51) |
Adjuvant | 19 (33) | 29 (46) | |
Adjuvant-tamoxifen | 18 (32) | 23 (37) | |
Adjuvant-others (aromatase inhibitor) | 1 (2) | 6 (10) | |
Metastatic | 4 (7) | 3(5) | |
Metastatic-tamoxifen | 3 (5) | 2 (3) | |
No | 35 (61) | 31 (49) | |
ER|PR status | ER + PR+ | 53 (93) | 57 (90) |
ER+PR− | 3 (5) | 6 (10) | |
ER-PR+ | 1 (2) | 0 | |
