Table 1.
Demographics and baseline characteristics (safety population, N = 174).
| Parameter | NPLS (175 mg/m2) (N = 85) Arm A |
NPLS (80 mg/m2) (N = 45) Arm B |
Conventional paclitaxel (175 mg/m2) (N = 44) Arm C |
|---|---|---|---|
| Age in years, mean (SD) | 48.2 (8.8) | 47.5 (9.7) | 49.5 (8.3) |
| Gender, female, n (%) | 85 (100) | 45 (100) | 44 (100) |
| BSA (m²), mean (SD) | 1.5 (0.2) | 1.4 (0.2) | 1.5 (0.2) |
| BMI (kg/m2) | 23.4 (4.8) | 22.7 (4.8) | 23.9 (4.9) |
| ECOG performance score, n (%) | |||
| 0 | 26 (30.6) | 22 (48.9) | 15 (34.1) |
| 1 | 52 (61.2) | 20 (44.4) | 23 (52.3) |
| 2 | 7 (8.2) | 3 (6.7) | 6 (13.6) |
| Menopausal status, n (%) | |||
| Pre-menopausal | 40 (47.1) | 18 (40) | 17 (38.6) |
| Post-menopausal | 45 (52.9) | 27 (60) | 27 (61.4) |
| Prior chemotherapy regimens in the metastatic setting, n (%) | |||
| 0 a | 45 (52.9) | 16 (35.6) | 26 (59.1) |
| 1 | 40 (47.1) | 29 (64.4) | 18 (40.9) |
a
Patients receiving study drugs as first-line therapy in metastatic settings included those who relapsed within 6 months of adjuvant chemotherapy.
BMI, body mass index; BSA, body surface area; ECOG, Eastern Cooperative Oncology Group; NPLS, nanosomal paclitaxel lipid suspension; SD, standard deviation.