Table 1.
Characteristics of the study population, the tumours, and the administered chemotherapy including toxicities
| Patient characteristics | Mean ± standard deviation or frequency (%) |
|---|---|
| Age at diagnosis (years) (n = 994) |
50.4 ± 9.6 |
| Body mass index (kg/m2) (n = 981) |
24.9 ± 4.1 |
| Body surface area (m2) (n = 993) |
1.7 ± 0.1 |
|
Tumour characteristics |
|
| Tumor status |
994 (100) |
| - Primary tumour |
966 (97.2) |
| - Relapsed tumour |
28 (2.8) |
| Tumour gradea |
979 (98.5) |
| - 1 |
39 (4.0) |
| - 2 |
334 (34.1) |
| - 3 |
606 (61.9) |
| Tumour type |
994 (100) |
| - Invasive ductal carcinoma |
823 (82.8) |
| - Invasive lobular carcinoma |
103 (10.4) |
| - Mixed |
27 (2.7) |
| - Others |
41 (4.1) |
| Tumour stageb |
978 (98.4) |
| - I |
113 (11.5) |
| - IIA |
306 (31.3) |
| - IIB |
245 (25.1) |
| - IIIA |
193 (19.7) |
| - IIIB |
44 (4.5) |
| - IIIC |
77 (7.9) |
| Receptor status |
|
| - Estrogen receptor positive |
683 (68.8) |
| - Progesterone receptor positive |
577 (58.1) |
| - HER2 positive |
205 (20.7) |
| Subtypec |
981 (98.7) |
| - Luminal A |
325 (33.1) |
| - Luminal B HER2- |
234 (23.9) |
| - Luminal B HER2+ |
121 (12.3) |
| - HER2-like |
84 (8.6) |
| - Triple negative |
217 (22.1) |
| Nottingham Prognostic Index (NPI)d (n = 757) |
5.0 ± 0.9 |
|
Chemotherapy characteristics |
|
| Chemotherapy setting |
994 (100) |
| - Adjuvant |
874 (87.9) |
| - Neoadjuvant |
120 (12.1) |
| Planned cycles of FEC chemotherapy |
994 (100) |
| - 3 cycles FEC |
559 (56.2) |
| - 4 or 5 cycles FEC |
2 (0.2) |
| - 6 cycles FEC |
433 (43.6) |
| Relative dose intensity (RDI) (n = 994) |
0.96 ± 0.1 |
| Growth factor use |
994 (100) |
| - Primary |
15 (1.5) |
| - Secondary |
325 (32.7) |
| - None |
654 (65.8) |
|
Baseline laboratory parameters |
|
| White blood cell count (109/L) (n = 985) |
7.2 ± 2.0 |
| Absolute neutrophil count (109/L) (n = 937) |
4.4 ± 1.6 |
| Haemoglobin (g/dl) (n = 989) |
13.3 ± 1.0 |
| Platelets (109/L) (n = 985) |
275.4 ± 65.1 |
| Total bilirubin (mg/dl) (n = 915) |
0.4 ± 0.2 |
| Creatinine (mg/dl) (n = 957) |
0.8 ± 0.1 |
| Alanine aminotransferase (U/L) (n = 955) |
23.3 ± 15.3 |
| Aspartate aminotransferase (U/L) (n = 955) |
21.9 ± 11.1 |
|
FEC chemotherapy toxicities |
|
| Febrile neutropenia |
166 (16.7) |
| - Febrile neutropenia in first cycle |
107 (10.7) |
| Prolonged (≥ 5 days) grade 4 neutropenia |
345 (34.7) |
| Deep neutropenia (< 100/μl) |
93 (9.4) |
| Other grade 3–4 toxicities | 46 (4.6) |