Table 1. Patients demography and characteristics.
Gemcitabine and Vinorelbine | Gemcitabine and Cisplatin | Gemcitabine and Capecitabine | ||||
---|---|---|---|---|---|---|
Randomised patients (n) | 46 | 45 | 50 | |||
Median age (years) (range) | 58 | (38–77) | 60 | (36–74) | 60 | (34–78) |
Median KPS (%) (range) | 100 | (70–100) | 95 | (70–100) | 95 | (70–100) |
N | % | N | % | N | % | |
Tumour metastatic sites | ||||||
Visceral | 41 | 89.1 | 37 | 82.2 | 45 | 90.0 |
Non-visceral only | 5 | 10.9 | 8 | 17.8 | 5 | 10.0 |
Number of metastatic sites | ||||||
1 | 12 | 26.1 | 13 | 28.9 | 12 | 24.0 |
2 | 19 | 41.3 | 24 | 53.3 | 24 | 48.0 |
⩾3 | 14 | 30.4 | 8 | 17.8 | 13 | 26.0 |
Unknown | 1 | 2.2 | 1 | 2.0 | ||
Hormone receptor status | ||||||
Positive | 28 | 60.9 | 26 | 57.8 | 25 | 50.0 |
Negative | 16 | 34.8 | 18 | 40.0 | 18 | 36.0 |
Unknown | 2 | 4.4 | 1 | 2.2 | 7 | 14.0 |
HER2 status | ||||||
Positive (IHC3+, FISH+) | 4 | 8.7 | 7 | 15.6 | 5 | 10.0 |
Negative | 32 | 69.6 | 30 | 66.7 | 35 | 70.0 |
Unknown | 10 | 21.7 | 8 | 17.8 | 10 | 20.0 |
Menopausal status | ||||||
Premenopausal | 10 | 21.7 | 8 | 17.8 | 4 | 8.0 |
Postmenopausal | 19a | 41.3 | 23 | 51.1 | 34a | 68.0 |
Unknown | 17 | 37.0 | 14 | 31.1 | 12 | 24.0 |
Prior hormonal treatment | ||||||
Prior hormonal treatment | 26 | 56.5 | 27 | 60.0 | 28 | 56.0 |
Unknown | 2 | 4.45 | — | — | 1 | 2.0 |
Prior chemotherapy (CTX) | ||||||
Prior anthracyclines | 24 | 52.2 | 26 | 57.8 | 31 | 62.0 |
Prior anthracyclines+taxanes | 20 | 43.5 | 19 | 42.2 | 19 | 38.0 |
Prior taxanes | 1 | 2.2 | — | — | — | — |
Unknown | 1 | 2.2 | — | — | — | — |
Prior (neo)adjuvant CTX | 33 | 71.7 | 32 | 71.1 | 39 | 78.0 |
Line of CTX for MBC | ||||||
1st line | 18 | 39.1 | 15 | 33.3 | 18 | 36.0 |
2nd line | 15 | 32.6 | 13 | 28.9 | 17 | 34.0 |
⩾3rd line | 11 | 23.9 | 8 | 17.8 | 10 | 20.0 |
Unknown | 2b | 4.4 | 9b | 20.0 | 5 | 10.0 |
Abbreviations: FISH=fluorescence in situ hybridisation; HER2=human epidermal growth factor receptor 2; IHC3+=immunohistochemistry (DAKO 3+); KPS=Karnofsky performance scale; MBC=metastatic breast cancer.
Statistical significant (P=0.01).
Statistical significant (P=0.03).