Table 1.
Patient and treatment characteristics
| Patient and treatment characteristics | |||||||
|---|---|---|---|---|---|---|---|
| Parameters | Pilot phase n = 32 | Validation phase n = 115 | |||||
| Relapse n = 16 | Control n = 16 | p value | Relapse n = 30 | Control n = 85 | p value | ||
| Age at diagnosis (years) | Median | 53.5 | 52 | 0.88 | 52 | 54 | 0.59 |
| Range | 36–71 | 35–74 | 33–79 | 37–78 | |||
| Menopause (n) | No | 4 (25 %) | 4 (25 %) | 1.0 | 11 (36.7 %) | 32 (37.6 %) | 0.37 |
| Yes | 8 (50 %) | 8 (50 %) | 17 (56.7 %) | 40 (47.1 %) | |||
| Unclear | 4 (25 %) | 4 (25 %) | 2 (6.7 %) | 13 (15.3 %) | |||
| T (n) | T1 | 10 (62.5 %) | 10 (62.5 %) | 1.0 | 26 (86.7 %) | 75 (88.2 %) | 0.82 |
| T2 | 6 (37.5 %) | 6 (37.5 %) | 4 (13.3 %) | 10 (11.8 %) | |||
| N (n) | N0 | 13 (81.3 %) | 13 (81.3 %) | 1.0 | 24 (80 %) | 67 (78.8 %) | 0.88 |
| N1 | 2 (12.5 %) | 2 (12.5 %) | 6 (20 %) | 18 (21.1 %) | |||
| N2 | 1 (6.3 %) | 1 (6.3 %) | 0 | 0 | |||
| M (n) | M0 | 16 (100 %) | 16 (100 %) | 1.0 | 30 (100 %) | 85 (100 %) | 1.0 |
| M1 | 0 | 0 | 0 | 0 | |||
| Grading (n) | G1 | 1 (6.3 %) | 0 | 0.87 | 3 (10 %) | 8 (9.4 %) | 0.75 |
| G2 | 8 (50 %) | 9 (56.3 %) | 18 (60 %) | 55 (64.7 %) | |||
| G3 | 7 (43.8 %) | 7 (43.8 %) | 9 (30 %) | 22 (25.9 %) | |||
| Histology (n) | IDC | 13 (81.3 %) | 15 (93.8 %) | 0.56 | 22 (73.3 %) | 63 (74.1 %) | 0.98 |
| ILC | 3 (18.8 %) | 1 (6.3 %) | 5 (16.7 %) | 12 (14.1 %) | |||
| Tubular | 0 | 0 | 2 (6.7 %) | 6 (7.1 %) | |||
| Other | 0 | 0 | 1 (3.3 %) | 4 (4.7 %) | |||
| In situ component (n) | Yes | 14 (87.5 %) | 10 (62.5 %) | 0.24 | 17 (56.7 %) | 47 (55.3 %) | 0.97 |
| No | 2 (12.5 %) | 6 (6.25 %) | 13 (43.3 %) | 35 (41.2 %) | |||
| Lymphangiosis | 0 | 0 | 0 | 1 (1.2 %) | |||
| Not stated | 0 | 0 | 0 | 2 (2.4 %) | |||
| Receptors (n) | ER positive | 8 (50 %) | 10 (62.5 %) | 0.56 | 23 (76 %) | 67 (78.8 %) | 0.81 |
| ER negative | 8 (50 %) | 6 (37.5 %) | 7 (23.3 %) | 18 (21.2 %) | |||
| PR positive | 8 (50 %) | 8 (50 %) | 0.56 | 19 (63.3 %) | 62 (72.9 %) | 0.32 | |
| PR negative | 8 (50 %) | 8 (50 %) | 11 (36.7 %) | 23 (27.1 %) | |||
| her2neu | Positive | 8 (50 %) | 4 (25 %) | 0.24 | 11 (37 %) | 24 (28 %) | 0.81 |
| Negative | 5 (31 %) | 9 (56 %) | 18 (60 %) | 44 (52 %) | |||
| Not assessable | 3 (19 %) | 3 (19 %) | 1 (3 %) | 17 (20 %) | |||
| Proliferation index | ki67 < 20 % | 10 (63 %) | 6 (38 %) | 0.24 | 15 (50 %) | 49 (58 %) | 0.78 |
| ki67 > 20 % | 5 (31 %) | 9 (56 %) | 10 (33 %) | 26 (31 %) | |||
| Not assessable | 1 (6 %) | 1 (6 %) | 5 (17 %) | 10 (11 %) | |||
| Boost (n) | Intraoperative | 8 (50 %) | 8 (50 %) | 1.0 | 11 (36.7 %) | 34 (40 %) | 0.91 |
| Percutaneous | 8 (50 %) | 8 (50 %) | 16 (53.3 %) | 51 (60 %) | |||
| None | 0 | 0 | 3 (10 %) | 0 | |||
| Boost dose (Gy) | Dose intraoperative | 10 Gy | 10 Gy | 0.84 | 10 Gy | 10 Gy | 0.58 |
| Dose percutaneous | 12 Gy | 12 Gy | 12 (15–19) Gy | 12 (9–19) Gy | |||
| WBRT dose (Gy) | Median | 54 Gy | 54 Gy | 0.78 | 54 Gy | 54 Gy | 0.68 |
| Range | 51.2–61.2 Gy | 51.2–57.8 Gy | 51–63 Gy | 51–57.6 Gy | |||
| Surgery (n) | BCT | 16 (100 %) | 15 (93.8 %) | 0.78 | 30 (100 %) | 85 (100 %) | 1.0 |
| Mastectomy | 0 | 1 (6.3 %) | 0 | 0 | |||
| Re-Excisition (n) | Yes | 8 (50 %) | 4 (25 %) | 0.24 | 12 (40 %) | 33 (38.8 %) | 0.91 |
| No | 8 (50 %) | 12 (75 %) | 18 (60 %) | 52 (61.2 %) | |||
| Year of surgery (n) | Before 1998 | 5 (31.3 %) | 5 (31.3 %) | 1.0 | 14 (46.7 %) | 38 (44.7 %) | 0.85 |
| Since 1998 | 11 (68.8 %) | 11 (68.8 %) | 16 (53.3 %) | 47 (55.3 %) | |||
| Chemotherapy (n) | Yes | 8 (50 %) | 6 (37.5 %) | 0.56 | 11 (36.7 %) | 20 (23.5 %) | 0.18 |
| No | 8 (50 %) | 10 (62.5 %) | 19 (63.3 %) | 65 (76.5 %) | |||
| Hormonal treatment (n) | Yes | 8 (50 %) | 7 (43.8 %) | 0.78 | 16 (53.3 %) | 56 (65.9 %) | 0.27 |
| No | 8 (50 %) | 9 (56.3 %) | 13 (43.3 %) | 26 (30.6 %) | |||
| Unclear | 0 | 0 | 1 (3.3 %) | 3 (3.5 %) | |||
| Tumor burden in biopsy (%) | Median | 70 | 50 | 0.34 | 70 | 50 | 0.52 |
| Range | 10–90 | 10–90 | 10–90 | 10–90 | |||
Patient and treatment characteristics as well as the relative tumor burden in the samples are shown. The relapse group and control were compared with the Mann-Whitney U test. Neither in the pilot nor in the validation phase statistically significant differences of potentially prognostic parameters were detected between the relapse and the control group. The stainings for her2 and ki-67 were performed according to the standard procedures implemented at the Department of Pathology. Because some of the specimens were quite old (minimum 5 years) in some cases, the stainings—even on repetition—did not yield valid result due to technical problems with the non-adhesive FFPE sections