Table 1.
Baseline status.
|
Group |
p values | ||
|---|---|---|---|
| IMS (n = 30) | Control (n = 31) | ||
| Age in years (mean, ±SD; t-test) | 48.4 ± 7.5 | 50.8 ± 8.0 | 0.228 |
| Tumour status (n; Chi square test) | |||
| Tumour classification | 0.879 | ||
| T1 | 7 | 9 | |
| T2 | 21 | 19 | |
| T3 | 1 | 2 | |
| Tx | 1 | 1 | |
| Pos. lymph nodes | 0.343 | ||
| N0 | 10 | 16 | |
| N1 | 19 | 14 | |
| N2 | 1 | 1 | |
| Tumour grade | 0.963 | ||
| G1 | 1 | 1 | |
| G2 | 24 | 24 | |
| G3 | 5 | 6 | |
| Menopause status (n; Kruskal-Wallis test) | 0.349 | ||
| Premenopausal | 17 | 13 | |
| Perimenopausal | 2 | 1 | |
| Postmenopausal | 11 | 17 | |
| Receptor status estrogen | 0.714 | ||
| + | 20 | 17 | |
| − | 8 | 12 | |
| Unknown | 2 | 2 | |
| Receptor status progesteron | 1.000 | ||
| + | 18 | 19 | |
| − | 10 | 10 | |
| Unknown | 2 | 2 | |
| Body Mass Index (mean, ±SD; t-test) | 27.0 ± 6.3 | 25.6 ± 4.7 | 0.709 |
| Karnofsky-Index (mean, ±SD) | 100 ± 0.0 | 100 ± 0.0 | |
| Abnormal findings on physical examination (n) | 0 | 0 | |
| Vital signs (mean, ±SD; t-test) | |||
| Blood pressure systolic mm(Hg) | 130.0 ± 20.0 | 132.2 ± 19.0 | 0.661 |
| Blood pressure diastolic mm(Hg) | 81.7 ± 12.5 | 83.6 ± 13.6 | 0.568 |
| Pulse (/m) | 82.3 ± 13.4 | 77.1 ± 10.1 | 0.094 |
| Temperature (°C) | 36.5 ± 0.1 | 36.6 ± 0.1 | 0.268 |
| Previous diseases (n) | 0 | 0 | |
| Primary endpoints | |||
| Neutropenia (n) | 0 | 0 | |
| EORTC-QLQ-C30 (mean, ±SD; Mann-Whitney U-test) | |||
| Global health status | 67.8 ± 20.4 | 68.5 ± 18.3 | 0.868 |
| Physical functioning | 86.0 ± 14.2 | 86.0 ± 12.4 | 0.852 |
| Role functioning | 65.5 ± 20.9 | 73.0 ± 16.9 | 0.143 |
| Emotional functioning | 75.8 ± 20.1 | 74.1 ± 18.1 | 0.623 |
| Cognitive functioning | 85.0 ± 20.7 | 79.3 ± 23.4 | 0.267 |
| Social functioning | 76.7 ± 19.4 | 80.5 ± 18.9 | 0.424 |
| Fatigue | 22.6 ± 17.2 | 25.7 ± 19.5 | 0.593 |
| Nausea and vomiting | 3.4 ± 9.3 | 2.9 ± 7.8 | 0.959 |
| Pain | 21.7 ± 21.5 | 16.1 ± 20.6 | 0.210 |
| Dyspnoea | 4.6 ± 14.7 | 3.4 ± 10.3 | 0.965 |
| Insomnia | 16.8 ± 21.1 | 23.0 ± 31.0 | 0.557 |
| Appetite loss | 12.6 ± 22.6 | 10.3 ± 20.1 | 0.625 |
| Constipation | 7.8 ± 14.3 | 6.9 ± 13.7 | 0.808 |
| Diarrhoea | 2.2 ± 8.5 | 2.3 ± 8.6 | 0.972 |
| Financial difficulties | 23.3 ± 23.4 | 20.7 ± 30.1 | 0.358 |