Table 1.
Baseline characteristics of patients
| Overall | Standard | Bi-weekly | |
|---|---|---|---|
| N = 88 | N = 40 | N = 42 | |
| Median age, (range) years | 59.5 (37–80) | 61.0 (37–80) | 60.0 (40–77) |
| ECOG performance status, n (%) | |||
| 0 | 59 (67.0) | 26 (65.0) | 30 (71.4) |
| 1 | 28 (31.8) | 14 (35.0) | 12 (28.6) |
| 2 | 1 (1.1) | 0 | 0 |
| ER/PgR positive, n (%) | 54 (61.4) | 23 (57.5) | 27 (64.3) |
| Triple-negative, n (%) | 34 (38.6) | 17 (42.5) | 15 (35.7) |
| No. of chemotherapies for MBC, n (%) | |||
| 0 | 15 (17.0) | 5 (12.5) | 9 (21.4) |
| 1 | 23 (26.1) | 14 (35.0) | 8 (19.0) |
| 2 | 27 (30.7) | 10 (25.0) | 14 (33.3) |
| 3 | 23 (26.1) | 11 (27.5) | 11 (26.2) |
| No. of prior chemotherapy regimens (median) | 2 | 2 | 2 |
| Prior chemotherapy for MBCa, n (%) | |||
| FEC | 26 (29.5) | 10 (25.0) | 13 (31.0) |
| Paclitaxel + bevacizumab | 26 (29.5) | 13 (32.5) | 10 (23.8) |
| nab-Paclitaxel | 12 (13.6) | 3 (7.5) | 8 (19.0) |
| Paclitaxel | 13 (14.8) | 7 (17.5) | 6 (14.3) |
| S-1 | 12 (13.6) | 4 (10.0) | 6 (14.3) |
| XC | 11 (12.5) | 5 (12.5) | 6 (14.3) |
| Capecitabine | 15 (17.0) | 9 (22.5) | 5 (11.9) |
| Docetaxel | 6 (6.8) | 4 (10.0) | 2 (4.8) |
| Prior surgery, n (%) | 79 (89.8) | 36 (90.0) | 37 (88.1) |
| Prior radiation therapy, n (%) | 29 (33.0) | 10 (25.0) | 15 (35.7) |
| Most common metastatic sitesa, n (%) | |||
| Liver | 47 (53.4) | 21 (52.5) | 24 (57.1) |
| Bone | 41 (46.6) | 22 (55.0) | 18 (42.9) |
| Lymph nodes | 24 (27.3) | 10 (25.0) | 12 (28.6) |
| Lung | 19 (21.6) | 9 (22.5) | 7 (16.7) |
| Axilla | 14 (15.9) | 6 (15.0) | 7 (16.7) |
| No. of metastatic sites, median | 1 | 1 | 2 |
Overall population = safety population = 88 patients
6 patients were excluded (2 due to progressive disease, 2 due to adverse events, 1 due to complication, 1 due to refusal)
Standard therapy group = efficacy analysis population = 40 patients
Biweekly therapy group = efficacy analysis population = 42 patients
ECOG Eastern Cooperative Oncology Group, ER estrogen receptor, PgR progesterone receptor, FEC 5-FU + epirubicin + cyclophosphamide, MBC metastatic breast cancer, S1 tegafur/gimeracil/oteracil potassium, XC capecitabine + cyclophosphamide
aData shown are for > 10% of patients