Table 1. Demographics and baseline disease characteristics.
| Variables | n (%) | ||||||||
| 50 mg QD (N=3) |
100 mg QD (N=3) |
200 mg QD (N=3) |
300 mg QD (N=3) |
400 mg QD (N=3) |
500 mg QD (N=3) |
600 mg QD (N=4) |
300 mg BID (N=6) |
All patients (N=28) |
|
| ECOG, Eastern Cooperative Oncology Group; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; FISH, fluorescence in situ hybridization. | |||||||||
| Age (year) [median (range)] |
61 (41−65) | 36 (35−40) | 59 (58−60) | 50 (50−60) | 60 (26−62) | 54 (47−58) | 57 (52−60) | 52 (25−62) | 59 (25−65) |
| Gender: female | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 4 (100) | 6 (100) | 28 (100) |
| ECOG score | |||||||||
| 0 | 0 (0) | 0 (0) | 1 (33.3) | 2 (66.7) | 3 (100) | 3 (100) | 3 (75.0) | 6 (100) | 18 (64.3) |
| 1 | 3 (100) | 3 (100) | 2 (66.7) | 1 (33.3) | 0 (0) | 0 (0) | 1 (25.0) | 0 (0) | 10 (35.7) |
| HER2 positive | |||||||||
| IHC 3+ | 3 (100) | 2 (66.7) | 3 (100) | 2 (66.7) | 2 (66.7) | 3 (100) | 3 (75.0) | 5 (83.3) | 23 (82.1) |
| FISH+ | 0 (0) | 1 (33.3) | 0 (0) | 1 (33.3) | 1 (33.3) | 0 (0) | 1 (25.0) | 1 (16.7) | 5 (17.9) |
| Tumor stage at study entry | |||||||||
| IV | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 4 (100) | 6 (100) | 28 (100) |
| Previous therapy | |||||||||
| Surgery | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 4(100) | 6 (100) | 28 (100) |
| Radiotherapy | 2 (66.7) | 1 (33.3) | 3 (100) | 2 (66.7) | 3 (100) | 2 (66.7) | 3 (75.0) | 4 (66.7) | 20 (71.4) |
| Chemotherapy | |||||||||
| 1−2 regimens | 1 (33.3) | 0 (0) | 1 (33.3) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 0 (0) | 1 (16.7) | 8 (28.6) |
| 3−7 regimens | 2 (66.7) | 3 (100) | 2 (66.7) | 2 (66.7) | 1 (33.3) | 1 (33.3) | 4 (100) | 5 (83.3) | 20 (71.4) |
| Anti-HER2 therapy | |||||||||
| Trastuzumab | 1 (33.3) | 3 (100) | 3 (100) | 0 (0) | 1 (33.3) | 1 (33.3) | 6 (100) | 3 (75.0) | 18 (64.3) |
| Pyrotinib | 0 (0) | 1 (33.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (3.6) |