Table 1.
Patient and disease characteristics of the FAS and pre-defined subgroups
| Population | Total FAS n = 126 | Patients < 65 years n = 103 | Patients ≥ 65 years n = 23 | HR+a n = 65 | HR−a n = 58 |
|---|---|---|---|---|---|
| Mean age (FAS) in years (SD) | 55.3 (SD 10.78) | 51.8 (SD 8.34) | 71.0 (SD 4.86) | 54.3 (SD 10.15) | 56.5 (SD 10.96) |
| ECOG at baseline | |||||
| 0 | 65 (51.6%) | 58 (56.3%) | 7 (30.4%) | 36 (55.4%) | 28 (48.3%) |
| 1 | 43 (34.1%) | 32 (31.1%) | 11 (47.8%) | 21 (32.3%) | 21 (36.2%) |
| 2 | 7 (5.6%) | 4 (3.9%) | 3 (13.0%) | 3 (4.6%) | 4 (6.9%) |
| 3 | 3 (2.4%) | 2 (1.9%) | 1 (4.3%) | 1 (1.5%) | 2 (3.4%) |
| Not done | 8 (6.3%) | 7 (6.8%) | 1 (4.3%) | 4 (6.2%) | 3 (5.2%) |
| Hormone receptor status | |||||
| HR+ (eBC) | 75 (59.5%) | 63 (61.2%) | 12 (52.2%) | 65a (100%) | |
| HR+ at NIS inclusion | 41 (32.5%) | 36 (35.0%) | 5 (21.7%) | 41 (63.1%) | |
| HR− (eBC) | 46 (36.5%) | 36 (35%) | 10 (43.5%) | 58a (100%) | |
| HR− at NIS inclusion | 42 (33.3%) | 33 (32.0%) | 9 (39.1%) | 42 (72.4%) | |
| HR unknown | 3 (2.9%) | ||||
| Patients with distant metastases | 115 (91.3%) | 93 (90.3%) | 22 (95.7%) | 59 (90.8%) | 54 (93.1%) |
| Metastatic status | |||||
| Visceral metastases | 92 (73.0%) | 73 (70.9%) | 19 (82.6%) | 47 (72.3%) | 44 (75.9%) |
| Non-visceral metastases | 23 (18.3%) | 20 (19.4%) | 3 (13.0%) | 12 (18.5%) | 10 (17.2%) |
| No metastases | 11 (8.7%) | 10 (9.7%) | 1 (4.3%) | 6 (9.2%) | 4 (6.9%) |
| HER2 IHC score primary tumor | |||||
| Positive+++ | 114 (90.5%) | 96 (93.2%) | 18 (78.3%) | 59 (90.8%) | 53 (91.4%) |
| Positive++b | 2 (1.6%) | 2 (1.9%) | 0 | 1 (1.5%) | 1 (1.7%) |
| Negative | 4 (3.2%) | 1 (1.0%) | 3 (13.0%) | 4 (6.2%) | 0 |
| Not examined/not evaluable | 8 (6.4%) | 4 (3.8%) | 2 (8.6%) | 1 (1.5%) | 4 (6.8%) |
| Re-testing of HER2 IHC at baseline | |||||
| Positive+++ | 82 (65.1%) | 68 (66.0%) | 14 (60.9%) | 40 (61.5%) | 41 (70.7%) |
| Positive++b | 1 (0.8%) | 1 (1.0%) | 0 | 0 | 1 (1.7%) |
| Negative | 1 (0.8%) | 1 (4.3%) | 1 (1.5%) | ||
| Not examined | 2 (1.6%) | 1 (1.0%) | 1 (4.3%) | 2 (3.1%) | |
| No re-testing | 40 (31.7%) | 33 (32.0%) | 7 (34.7%) | 22 (33.8%) | 16 (27.6%) |
| Method of surgery of primary tumor breast conserving | 56 (44.4%) | 46 (44.7%) | 10 (43.5%) | 31 (47.7%) | 25 (43.1%) |
| Mastectomy | 51 (40.5%) | 42 (40.8%) | 9 (38.7%) | 25 (38.5%) | 24 (41.3%) |
| Other | 9 (7.1%) | 9 (8.7%) | 0 | 7 (10.8%) | 2 (3.4%) |
| Missing | 8 (6.3%) | 5 (4.9%) | 3 (13.0%) | 1 (1.5%) | 6 (10.3%) |
| Resectability of primary tumor | |||||
| R0 | 113 (89.7%) | 90 (87.4%) | 23 (100%) | 59 (90.8%) | 51 (87.9%) |
| R1 | 1 (0.8%) | 1 (1.0) | 0 | 1 (1.5%) | 0 |
| RX | 3 (2.4%) | 3 (2.9%) | 0 | 1 (1.5%) | 2 (3.4%) |
| Unknown | 9 (7.1%) | 9 (8.7%) | 0 | 4 (6.2%) | 5 (8.6%) |
| Time (mean, years) from primary diagnosis to start of therapy with P | 4.7 (SD 2.27) | 4.4 (SD 2.22) | 5.7 (SD 2.26) | 5.0 (SD 2.32) | 4.3 (SD 2.19) |
| Any concomitant disease | 89 (70.6%) | 69 (67.0%) | 20 (87.0%) | 44 (67.7%) | 44 (75.9%) |
eBC early breast cancer, ECOG eastern cooperative oncology group, FAS full analysis set, HER2 human epidermal growth factor receptor 2, IHC immunohistochemistry, HR hormone receptor, P pertuzumab, n number, NIS non-interventional study, SD standard deviation, T trastuzumab
aHR status at start of NIS in case available (n = 83), otherwise HR status at initial diagnosis was used (n = 40). 13 patients had a switch HR positive to negative, and 3 patients a switch HR negative to positive.HR status in NIS unknown in 3 patients
bIHC (++) patients have a positive FISH or CISH test. In case IHC is negative, not evaluable/unknown or not investigated all patients have a positive FISH or CISH test, either for the primary tumor or at the re-test