Table 2.
Objective responses
| 2a. ITT on all enrolled patients | ||||||
|---|---|---|---|---|---|---|
| Arm A (EV) (54) | Arm B (PLD/V) (50) | |||||
| No. | % | No. | % | |||
| CR | 3 | 5.6 | 42.6% | 8 | 16.0 | 52.0% |
| PR | 20 | 37.0 | 42.6% | 18 | 36.0 | 52.0% |
| NC | 19 | 35.2 | 12 | 24.0 | ||
| PD | 6 | 11.1 | 9 | 18.0 | ||
| 2b. On evaluable patients | ||||||
| Arm A (EV) (54) | Arm B (PLD/V) (47) | |||||
| No. | % | No. | % | |||
| CR | 3 | 6.3 | 47.9% | 8 | 17.0 | 55.3% |
| PR | 20 | 41.6 | 47.9% | 18 | 38.7 | 55.3% |
| NC | 19 | 39.6 | 12 | 25.5 | ||
| PD | 6 | 12.5 | 9 | 19.2 | ||
| 2c. Overall response rates according to disease sites in evaluable patients (%) | ||||||
| Arm A (EV) (48) | Arm B (PLD/V) (47) | |||||
| Soft tissue | 66.6 | 77.7 | ||||
| Bone | 33.3 | 37.5 | ||||
| Viscera | 50. | 53.3 | ||||
Abbreviations: EV = epirubicin, vinorelbine; PLD/V = pegylated liposomal doxorubicin/vinorelbine; ITT = intent to treat; CR = complete response; PR = partial response; NC = no change; PD = progressive disease