Table 1.
Baseline characteristics of evaluable patients in MIMOSA trial.
| Total N=11 | |
|---|---|
| Age, median (range) | 55,1y, (44–62) |
| WHO performance status, no. (%) | |
| 0 | 10 (91) |
| 1 | 1 [9] |
| Germline BRCA1/2, no. (%) | |
| Pathogenic variant | 1 [9] |
| Wildtype | 2 [18] |
| Unknown | 8 (73) |
| Hormone receptor status, no. (%) | |
| ER+a | 9 (82) |
| ER- | 2 [18] |
| TIL-score, median (range) | 1% [[1], [2], [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20]] |
| LDH at baseline, no. | |
| ≤1x ULN | 7 (64) |
| ≤2x ULN | 4 (36) |
| Disease-free interval | |
| De novo metastatic disease | 4 (36) |
| DFS ≥12 months | 7 (64) |
| No. of metastatic sites, no. (%) | |
| 1-2 | 3(27) |
| ≥3 | 8 (73) |
| Location of metastasis, no. (%) | |
| Lymph node only | 0 (0) |
| Visceral metastasis | 9 (82) |
| Other metastatic sitesb | 4 (36) |
| No. of previous lines of therapy for MBCc, no. (%) | |
| 1 | 3 [27] |
| 2-3 | 8 (73) |
| Previous anti-HER2 therapy, no. (%) | |
| Trastuzumab | 11 (100) |
| Pertuzumab | 9 (82) |
| TDM-1 | 6 (55) |
| Lapatinib | 1 [9] |
Abbreviations: WHO performance status: World Health Organization performance status; LVEF: left ventricular ejection fraction; BRCA: Breast Cancer-1 or -2 gene; ER: estrogen receptor, TIL: tumor-infiltrating lymphocytes; LDH: lactate-dehydrogenase; MBC: metastatic breast cancer; TDM-1: trastuzumab emtansine.
a
ER-positivity is defined as ER-expression of ≥10%.
b
Other metastatic sites include bone, brain, skin and subcutaneous tissue.
c
Prior lines of chemotherapy with/without anti-HER2 agent and/or ADCs.