Table 1.
Demographic and clinical characteristics of patients with refractory metastatic breast cancer at baseline.
| THL-P (n = 30) | Placebo (n = 14) | P value | |
|---|---|---|---|
| Demographics | |||
|
| |||
| Age (years)a | 60.7 ± 9.5 | 58.7 ± 7.6 | 0.507 |
| Height (cm)a | 155.3 ± 5.9 | 156.5 ± 5.4 | 0.512 |
| Weight (kg)a | 57.6 ± 8.1 | 59.3 ± 10.5 | 0.554 |
| T stage, n (%)b | |||
| T1 | 4 (13.4) | 1 (7.2) | 0.968 |
| T2 | 12 (40.0) | 7 (50.0) | |
| T3 | 7 (23.3) | 3 (21.4) | |
| T4 | 7 (23.3) | 3 (21.4) | |
| Lymph nodes, n (%)b | |||
| N0 | 10 (33.3) | 3 (12.4) | 0.306 |
| N1 | 6 (20.0) | 2 (14.3) | |
| N2 | 4 (13.4) | 2 (14.3) | |
| N3 | 10 (33.3) | 7 (50.0) | |
| Metastasis, n (%)b | |||
| M1 | 30 (100) | 14 (100) | N/A |
| Duration of onset (years)c | 3.5 (2.0, 7.0) | 4.1 (2.7, 5.4) | 0.970 |
|
| |||
| EORTO-QLQ-C30 | |||
|
| |||
| GHS/QOL c | 37.5 (16.7, 50.0) | 50.0 (25.0, 66.7) | 0.082 |
| Functional scales | |||
| Physicalc | 60.0 (46.7, 73.3) | 70.0 (46.7, 86.7) | 0.336 |
| Rolec | 66.7 (33.3, 83.3) | 66.7 (33.3, 100.0) | 0.643 |
| Emotionalc | 66.7 (50.0, 83.3) | 75. 0 (58.3, 91.7) | 0.469 |
| Cognitivec | 66.7 (50.0, 83.3) | 83.3 (66.7, 83.3) | 0.118 |
| Socialc | 66.7 (33.3, 100.0) | 66.7 (66.7, 100.0) | 0.711 |
| Symptom scales | |||
| Fatiguec | 55.6 (33.3, 66.7) | 38.9 (22.2, 55.6) | 0.273 |
| Nausea and vomitingc | 0 (0, 16.7) | 0 (0, 0) | 0.362 |
| Painc | 33.3 (0, 66.7) | 8.3 (0, 50.0) | 0.382 |
| Single items | |||
| Dyspnoeac | 33.3 (0, 66.7) | 0 (0, 33.3) | 0.069 |
| Insomniac | 33.3 (0, 33.3) | 33.3 (0, 66.7) | 0.608 |
| Appetite lossc | 33.3 (0, 66.7) | 0 (0, 33.3) | 0.367 |
| Constipationc | 0 (0, 33.3) | 0 (0, 33.3) | 0.403 |
| Diarrhoeac | 0 (0, 0) | 0 (0, 33.3) | 0.523 |
| Financial difficultiesc | 33.3 (0, 33.3) | 33.3 (0, 33.3) | 0.746 |
THL-P: Tien-Hsien liquid practical: EORTO-QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; GHS: global health status; QOL: quality of life.
P values were determined via the independent, two sample t-testa, Fisher's exact testb, and Mann-Whitney U testc. Values are presented as mean ± standard deviationa, number (percentage)b, and median (interquartile)c.