Table 3.
Subgroup analyses of progression-free survival
| n | Number of events, n (%) | Median PFS, months (95% CI) | HR (95% CI) | |
|---|---|---|---|---|
| Overall population | 132 | 70 (53.0) | 22.8 (16.9–37.5) | – |
| Prior (neo)adjuvant therapya | ||||
| Yes | 38 | 18 (47.4) | 27.7 (12.4–NE) | 0.91 (0.53–1.56) |
| No | 94 | 52 (55.3) | 20.8 (16.9–38.8) | – |
| Age | ||||
| < 65 | 96 | 53 (55.2) | 22.8 (16.5–37.5) | 1.29 (0.75–2.23) |
| ≥ 65 | 36 | 17 (47.2) | 33.1 (18.7–NE) | – |
| Site of disease | ||||
| Non-visceral | 51 | 19 (37.3) | 37.5 (20.7–NE) | 0.62 (0.37–1.06) |
| Visceral | 81 | 51 (63.0) | 18.4 (13.8–33.7) | – |
| HER2 status IHC/ISH | ||||
| IHC ≤ 2 + and ISH-positive | 21 | 13 (61.9) | 16.5 (10.4–34.8) | – |
| IHC 3 + | 111 | 57 (51.4) | 22.9 (18.4–49.5) | 0.66 (0.36–1.21) |
| HR status | ||||
| ER- and/or PgR-positive | 72 | 41 (56.9) | 18.9 (14.7–33.1) | – |
| ER- and PgR-negative | 60 | 29 (48.3) | 33.7 (20.6–NE) | 0.79 (0.49–1.27) |
| Menopausal status | ||||
| Premenopausal | 46 | 27 (58.7) | 22.8 (16.6–49.5) | – |
| Postmenopausal | 86 | 43 (50.0) | 22.8 (14.6–NE) | 1.05 (0.65–1.70) |
| Recurrence | ||||
| De novo metastatic disease | 83 | 48 (57.8) | 20.7 (16.6–37.5) | – |
| Recurrent metastatic diseaseb | 49 | 22 (44.9) | 28.1 (16.7–NE) | 0.77 (0.47–1.28) |
CI confidence interval, ER estrogen receptor, HER2 human epidermal growth factor receptor 2, HR hazard ratio, IHC immunohistochemistry, ISH in situ hybridization, PFS progression-free survival, PgR progesterone receptor
aIncludes prior trastuzumab and/or chemotherapy (patients receiving hormonal therapy alone are included in the ‘No’ population)
bPatients with non-recurrence were classified as having "de novo metastatic disease”