Table 4 Activity and efficacy by treatment arm and clinical setting
| Â | Whole set | Locally advanced | Metastatic not pre-treated with anthracyclines | Metastatic pre-treated with anthracyclines | ||||
|---|---|---|---|---|---|---|---|---|
| Â | 3-weekly N = 69 | Weekly N = 66 | 3-weekly N = 22 | Weekly N = 20 | 3-weekly N = 26 | Weekly N = 26 | 3-weekly N = 21 | Weekly N = 20 |
Objective response | Â | Â | Â | Â | Â | Â | Â | Â |
   Complete response, n | 7 | 2 | 2 | 1 | 2 | - | 3 | 1 |
   Partial response, n | 20 | 20 | 9 | 9 | 7 | 7 | 4 | 4 |
   Stable disease, n | 19 | 16 | 10 | 8 | 8 | 7 | 1 | 1 |
   Progressive disease, n | 5 | 9 | - | 1 | 2 | 4 | 3 | 4 |
   Not evaluable (non responding), n | 18 | 19 | 1 | 1 | 7 | 8 | 10 | 10 |
   Response rate, % (95% exact CI) | 39.1 (27.6-51.6) | 33.3 (22.2-46.0) | 50.0 (28.2-71.8) | 50.0 (27.2-72.8) | 34.6 (17.2-55.7) | 26.9 (11.6-47.8) | 33.3 (14.6-57.0) | 25.0 (8.7-49.1) |
Progression free survival | Â | Â | Â | Â | Â | Â | Â | Â |
   Progressed patients, n (%) | 42 (60.9) | 44 (66.7) | 6 (27.3) | 6 (30.0) | 18 (69.2) | 20 (76.9) | 18 (85.7) | 18 (90.0) |
   Median, months (95% CI) | 15.2 (11.8-36.6) | 13.1 (7.7-22.4) | n.r. | n.r. | 11.9 (10.2-36.6) | 10.4 (6.2-22.4) | 9.1 (5.9-29.7) | 6.2 (4.2-14.4) |
   HR weekly vs 3 weekly (95% CI) | 1.29 (0.84-1.97) | 1.10 (0.35-3.45) | 1.29 (0.67-2.47) | 1.52 (0.78-2.97) | ||||
Overall survival | Â | Â | Â | Â | Â | Â | Â | Â |
   Dead patients, n (%) | 27 (39.1) | 32 (48.5) | 3 (13.6) | 2 (10.0) | 13 (50.0) | 15 (57.7) | 11 (52.4) | 15 (75.0) |
Median, months (95% CI) | 42.9 (27.7-na) | 33.0 (25.2-na) | n.r. | n.r. | 26.7 (21.2-na) | 28.5 (11.4-na) | 33.2 (16.3-na) | 28.8 (19.8-na) |
   HR weekly vs 3 weekly (95% CI) | 1.38 (0.82-2.30) | 0.78 (0.13-4.69) | 1.41 (0.67-2.99) | 1.54 (0.70-3.36) | ||||