Table 1.
Summary of patient demographics and baseline characteristics
| 25 mg (N = 1) | 50 mg (N = 4) | 100 mg (N = 4) | 200 mg (N = 5) | 250 mg (N = 5) | 300 mg (N = 4) | Total (N = 23) | |
|---|---|---|---|---|---|---|---|
| Age (year) | |||||||
| Median | 64 | 57.5 | 50.0 | 61.0 | 57.0 | 42.0 | 57.0 |
| Min, Max | 64, 64 | 47, 63 | 36, 61 | 46, 66 | 38, 71 | 39, 63 | 36, 71 |
| Age group, n (%) | |||||||
| < 60 | 0 (0.0) | 3 (75.0) | 2 (50.0) | 2 (40.0) | 3 (60.0) | 3 (75.0) | 13 (56.5) |
| ≥ 60 | 1 (100.0) | 1 (25.0) | 2 (50.0) | 3 (60.0) | 2 (40.0) | 1 (25.0) | 10 (43.5) |
| Race, n (%) | |||||||
| Asian | 1 (100.0) | 3 (75.0) | 2 (50.0) | 5 (100.0) | 3 (60.0) | 3 (75.0) | 17 (73.9) |
| White | 0 (0.0) | 0 (0.0) | 2 (50.0) | 0 (0.0) | 2 (40.0) | 0 (0.0) | 4 (17.4) |
| Other | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 2 (8.7) |
| Metastatic sites, n (%) | 1 (100.0) | 4 (100.0) | 4 (100.0) | 5 (100.0) | 5 (100.0) | 4 (100.0) | 23 (100.0) |
| With BM, n (%) | 0 (0.0) | 4 (100.0) | 3 (75.0) | 2 (40.0) | 3 (60.0) | 2 (50.0) | 14 (60.9) |
| With LM, n (%) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.3) |
| Without CNS, n (%) | 1 (100.0) | 0 (0.0) | 0 (0.0) | 3 (60.0) | 2 (40.0) | 2 (50.0) | 8 (34.8) |
| ECOG, n (%) | |||||||
| 0 | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 1 (25.0) | 3 (13.0) |
| 1 | 1 (100.0) | 3 (75.0) | 4 (100.0) | 5 (100.0) | 4 (80.0) | 3 (75.0) | 20 (87.0) |
| With surgical therapy, n (%) | 1 (100.0) | 4 (100.0) | 3 (75.0) | 5 (100.0) | 5 (100.0) | 3 (75.0) | 21 (91.3) |
| With radiation therapy (intracranial and/or extracranial), n (%) | 1 (100.0) | 4 (100.0) | 4 (100.0) | 5 (100.0) | 3 (60.0) | 3 (75.0) | 20 (87.0) |
| With any prior systemic anticancer therapy, n (%) | 1 (100.0) | 4 (100.0) | 4 (100.0) | 5 (100.0) | 5 (100.0) | 4 (100.0) | 23 (100.0) |
| Median | 7.0 | 9.0 | 5.5 | 9.0 | 8.0 | 5.5 | 7.0 |
| Min, max | 7, 7 | 3, 15 | 4, 8 | 4, 10 | 6, 11 | 3, 9 | 3, 15 |
| Therapy class, n (%) | |||||||
| HER2 antibody and/or ADC | 1 (100.0) | 4 (100.0) | 4 (100.0) | 5 (100.0) | 5 (100.0) | 4 (100.0) | 23 (100.0) |
| HER2 TKI | 0 (0.0) | 3 (75.0) | 3 (75.0) | 5 (100.0) | 4 (80.0) | 4 (100.0) | 19 (82.6) |
| Chemotherapy | 1 (100.0) | 4 (100.0) | 4 (100.0) | 5 (100.0) | 5 (100.0) | 4 (100.0) | 23 (100.0) |
| Endocrine therapy | 1 (100.0) | 2 (50.0) | 2 (50.0) | 3 (60.0) | 4 (80.0) | 2 (50.0) | 14 (60.9) |
| Other | 0 (0.0) | 2 (50.0) | 1 (25.0) | 3 (60.0) | 5 (100.0) | 2 (50.0) | 13 (56.5) |
N number of subjects in the analysis set for each treatment group, Max maximum, Min minimum, BM brain metastasis, LM leptomeningeal metastasis, ADC antibody–drug conjugate, TKI tyrosine kinase inhibitor. The percentage was calculated based on N as the denominator. Patients with BM are defined as BM regardless of with or without extracranial metastases. Patients with LM are defined as LM regardless of the patients are with or without extracranial/brain metastases