Table 2. Baseline patient and demographic characteristics (n=188).
| Characteristic | Study population, n (%) |
|---|---|
| Age, years, median (range) | 57 (32–76) |
| Weight, kg, median (range) | 71 (43–150) |
| Body surface area, m2, median (range) | 1.79 (1.36–2.70) |
| Baseline ECOG performance statusa | |
| 0 | 99 (53) |
| 1 | 89 (47) |
| Oestrogen receptor and/or progesterone receptor | |
| Positive | 164 (87) |
| Negative | 24 (13) |
| Metastases at initial diagnosis | |
| Yes | 25 (13) |
| No | 163 (87) |
| Sites of metastatic disease | |
| Lung metastasis | 63 (34) |
| Liver metastasis | 116 (62) |
| Bone-only disease | 10 (5) |
| No. of metastatic sites | |
| 1 | 23 (12) |
| 2 | 69 (37) |
| ⩾3 | 96 (51) |
| Prior (neo)adjuvant chemotherapy | |
| Anthracycline-containing | 94 (87) |
| CMF | 12 (11) |
| Other | 2 (2) |
| Radiotherapy | |
| Primary breast cancer | 122 (65) |
| Recurrent or metastatic breast cancer | 64 (34) |
| Preexisting diabetes mellitus | |
| Yes | 3 (2) |
| No | 185 (98) |
| Pre-treatment biochemical values of liver and kidney function, median (range) | |
| Aspartate aminotransferase, U l−1 (n=188) | 33 (13–250) |
| Alanine aminotransferase, U l−1 (n=187) | 28 (6–340) |
| Alkaline phosphatase, U l−1 (n=186) | 113 (40–690) |
| Total bilirubin, μmol l−1 (n=186) | 7 (2–27) |
| Albumin, g l−1 (n=181) | 42 (25–51) |
| Blood urea nitrogen, mmol l−1 (n=158) | 4.9 (2.2–15.5) |
| Serum creatinine, μmol l−1 (n=188) | 67 (35–145) |
Abbreviations: CMF=cyclophosphamide, methotrexate and fluorouracil; ECOG=Eastern Cooperative Oncology Group.
a
Patients with ECOG PS ⩾2 were excluded from clinical trial.