DESTINY-Breast01: BM Subgroup Patients Demographics and Baseline Characteristics (August 1, 2019 DCO Date)
Patient Disposition1
- 24 patients (13.0%) had BM at baseline1
- 11 (45.8%) ongoing
- 13 (54.2%) discontinued, primarily for progressive disease (6/24, 25.0%)
Baseline Characteristics2
| Demographic Variable | BM Subgroup (n=24) | Non-BM Subgroup (n=160) | All Patients (N=184) |
| Age, median (range), yearsa | 58.0 (33.0-85.0) | 55.0 (28.0-96.0) | 55.0 (28.0-96.0) |
| ≥65 years, n (%) | 9 (37.5) | 35 (21.9) | 44 (23.9) |
| Female, n (%) | 24 (100) | 160 (100) | 184 (100) |
| Race, n (%) | |||
| Asian | 9 (37.5) | 61 (38.1) | 70 (38.0) |
| White | 13 (54.2) | 88 (55.0) | 101 (54.9) |
| Other | 1 (4.2) | 2 (1.3) | 3(1.6) |
| Missing | 1 (4.2) | 3 (1.9) | 4 (2.2) |
| Region, n (%) | |||
| Europe | 9 (37.5) | 59 (36.9) | 68 (37.0) |
| Asia | 9 (37.5) | 54 (33.8) | 63 (34.2) |
| North America | 6 (25.0) | 47 (29.4) | 53 (28.8) |
| ECOG PS, n (%) | |||
| 0 | 15 (62.5) | 87 (54.4) | 102 (55.4) |
| 1 | 9 (37.5) | 72 (45.0) | 81 (44.0) |
| 2 | 0 | 1 (0.6) | 1 (0.5) |
| HR status, n (%) | |||
| Positive | 9 (37.5) | 88 (55.0) | 97 (52.7) |
| Negative | 14 (58.3) | 69 (43.1) | 83 (45.1) |
| Unknown | 1 (4.2) | 3 (1.9) | 4 (2.2) |
| HER2 expression, n (%)b | |||
| IHC 3+ | 19 (79.2) | 135 (84.4) | 154 (83.7) |
| IHC 1+ or 2+, ISH+ | 5 (20.8) | 23 (14.4) | 28 (15.2) |
| Missing data | 0 | 2 (1.3) | 2 (1.1) |
| Sum of diameters of target lesions, median (range), cm | 6.4 (1.2-15.1) | 5.4 (1.4-24.5) | 5.5 (1.2-24.5) |
| No. of prior cancer regimens in the metastatic setting, median (range) | 6 (3-16) | 6 (2-27) | 6 (2-27) |
| Prior cancer systemic therapy, n (%) | |||
| Trastuzumab | 24 (100) | 160 (100) | 184 (100) |
| T-DM1c | 24 (100) | 160 (100) | 184 (100) |
| Pertuzumab | 15 (62.5) | 106 (66.3) | 121 (65.8) |
| Other anti-HER2 therapies | 15 (62.5) | 85 (53.1) | 100 (54.3) |
| HER2 TKI | 15 (62.5) | 78 (48.8) | 93 (50.5) |
| Hormone therapy | 11 (45.8) | 79 (49.4) | 90 (48.9) |
| Other systemic therapy | 24 (100) | 159 (99.4) | 183 (99.5) |
| Radiation therapy (any location) | 20 (83.3) | 110 (68.8) | 130 (70.7) |
| Best response to T-DM1 therapy, n (%) | |||
Complete response/partial response/stable disease | 10 (41.7) | 69 (43.1) | 79 (42.9) |
| Progressive disease | 10 (41.7) | 56 (35.0) | 66 (35.9) |
| Not evaluable | 4 (16.7) | 35 (21.9) | 39 (21.2) |
| Presence of visceral disease, n (%) | 24 (100) | 145 (90.6) | 169 (91.8) |
| Prior CNS treatment, n (%)d | |||
| Radiotherapy only | 14 (58.3) | ─ | ─ |
| Surgery only | 1 (4.2) | ─ | ─ |
| Radiotherapy plus surgery | 3 (12.5) | ─ | ─ |
Radiotherapy plus surgery plus capecitabine | 1 (4.2) | ─ | ─ |
| None reported | 5 (20.8) | ─ | ─ |
Abbreviations
BM = brain metastases
;CNS = central nervous system
;DCO = data cut-off
;ECOG = Eastern Cooperative Oncology Group
;HER2 = human epidermal growth factor receptor 2
;HR = hormone receptor
;IHC = immunohistochemistry
;ISH = in situ hybridization
;PS = performance status
;T-DM1 = trastuzumab emtansine
;TKI = tyrosine kinase inhibitor
References
2. Jerusalem G, Park Y, Yamashita S, et al. Trastuzumab deruxtecan in HER2-positive metastatic breast cancer patients with brain metastases: A DESTINY-Breast01 subgroup analysis [article and supplementary appendix]. Cancer Discov. 2022;12(12):2754-2762
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