Table 1.
Patient characteristics of the screening populations.
| Learning Set BEV + CT (n = 58) |
Control Set CT Alone (n = 57) |
||||
|---|---|---|---|---|---|
| Median age (Range) | 62 | (34–81) | 59 | (36–86) | |
| DFS | ≤24 months | 15 | (26%) | 9 | (16%) |
| >24 months | 27 | (47%) | 34 | (60%) | |
| de novo metastatic | 16 | (28%) | 14 | (25%) | |
| ECOG PS | 0–1 | 56 | (97%) | 51 | (90%) |
| 2–4 and unknown | 2 | (3%) | 7 | (12%) | |
| Histology | Ductal | 43 | (74%) | 45 | (79%) |
| Lobular | 11 | (19%) | 7 | (12%) | |
| Others and unknown | 4 | (7%) | 5 | (9%) | |
| Grade | 1 | 1 | (2%) | 3 | (5%) |
| 2 | 34 | (59%) | 32 | (56%) | |
| 3 | 22 | (38%) | 21 | (37%) | |
| Unknown | 1 | (2%) | 1 | (2%) | |
| Receptor Status | HR+/HER2−/G1–2 | 30 | (52%) | 24 | (42%) |
| HR+/HER2−/G3 | 11 | (19%) | 9 | (16%) | |
| HR+/HER2+ | 2 | (3%) | 9 | (16%) | |
| HR−/HER2+ | 1 | (2%) | 4 | (7%) | |
| Triple negative | 13 | (22%) | 10 | (18%) | |
| HR+/HER2−/G unknown | 1 | (3%) | 1 | (2%) | |
| Metastases | Visceral | 37 | (64%) | 37 | (65%) |
| Non-visceral | 21 | (36%) | 20 | (35%) | |
| Adjuvant Endocrine Therapy | 27 | (47%) | 26 | (46%) | |
| Adjuvant Chemotherapy 1 | Anthracycline alone | 8 | (14%) | 10 | (18%) |
| Taxane alone | 0 | (0%) | 0 | (0%) | |
| Anthracycline and taxane | 20 | (35%) | 6 | (11%) | |
| No adjuvant chemotherapy | 27 | (47%) | 35 | (61%) | |
| Chemotherapy Backbone 2,3 | Paclitaxel | 30 | (52%) | 214 | (37%) |
| Docetaxel | 5 | (9%) | 115 | (19%) | |
| Capecitabine | 21 | (36%) | 9 6 | (16%) | |
| Taxane and trastuzumab | 2 | (3%) | 10 7 | (18%) | |
| Others | 0 | (0%) | 6 8 | (11%) | |
| Sample Type | Primary tumor | 42 | (72%) | 38 | (67%) |
| Metastasis | 16 | (28%) | 19 | (33%) | |
| Biopsy | 22 | (38%) | 27 | (47%) | |
| Resection | 36 | (62%) | 30 | (53%) | |
| PFS | Number of events | 54 | (93%) | 53 | (93%) |
| Median PFS (95%-CI) | 10.91 (8.02–14.55) | 11.79 (8.74–16.3) | |||
| OS | Number of events | 44 | (76%) | 50 | (88%) |
| Median OS (95%-CI) | 27.3 (22.1–40.4) | 23.0 (12.4–36.2) | |||
As the learning set and control set are not compared with each other, no p value is given. BEV:bevacizumab; CT: chemotherapy; DFS: disease-free survival; ECOG PS: Eastern Cooperative Oncology Group Performance Status; HR: hormone receptor; PFS: progression-free survival; OS: overall survival. 1 Test performed without empty categories ′taxane′ and ′de novo metastatic disease′ using Fisher’s exact test. In the control group 29 patients were treated with a chemotherapy combination. 2,3 Paclitaxel was combined in eight patients (14.0%) with epirubicin and in one patient (1.8%) with capecitabin. Docetaxel was combined in five patients (8.8%) with epirubicin. Capecitabine was combined in three patients (5.2%) with vinorelbine and in one patient (1.8%) with gemcitabine. Taxan and trastuzumab was combined in two patients (3.5%) with epirubicin. five Patients (8.8%) received epirubicin in combination with cyclophosphamide.