Table 1.
Baseline characteristics of patients with metastatic breast cancer
| Capecitabine plus lurbinectedin |
||
|---|---|---|
| RD (capecitabine 1650 mg/m2 D1-D14/lurbinectedin 2.2 mg/m2 D1) (n = 15) |
All dose levels (n = 28) | |
| Age, years | ||
| Median (range) | 46.0 (29-71) | 51.5 (29-71) |
| ≤40 | 2 (13) | 3 (11) |
| 41-60 | 8 (53) | 17 (61) |
| >60 | 5 (33) | 8 (29) |
| ECOG performance status | ||
| 0 | 11 (73) | 18 (64) |
| 1 | 4 (27) | 10 (36) |
| Median BSA, m2 (range) | 1.7 (1.5-2.1) | 1.7 (1.3-2.2) |
| HR and HER2/neu expression | ||
| HR positive | 9 (60) | 20 (71) |
| HR positive/HER2/neu negative | 8 (53) | 19 (68) |
| HR positive/HER2/neu positive | 1 (7) | 1 (4) |
| Triple negative | 6 (40) | 8 (29) |
| BRCA mutation | ||
| BRCA1+ | 4 (27) | 4 (14) |
| BRCA2+ | 1 (4) | |
| BRCA1/2 wild type | 4 (27) | 6 (21) |
| Unknown | 7 (47) | 17 (61) |
| Bulky disease (any target lesion ≥50 mm) | 5 (33) | 7 (25) |
| No. of metastatic sites | ||
| Median (range) | 3.0 (2-6) | 3.0 (1-6) |
| 1 | 1 (4) | |
| 2 | 6 (40) | 7 (25) |
| ≥3 | 9 (60) | 20 (71) |
| Sites of disease | ||
| Viscerala | 15 (100) | 27 (96) |
| Liver | 12 (80) | 22 (79) |
| Bone | 10 (67) | 18 (64) |
| CNS | 1 (4) | |
| No. of lines of prior therapy for advanced disease | ||
| Median (range) | 1.0 (0-3) | 1.0 (0-3) |
| 0b | 3 (20) | 8 (29) |
| 1 | 5 (33) | 9 (32) |
| 2 | 6 (40) | 10 (36) |
| 3 | 1 (7)c | 1 (4)c |
| Prior anticancer agents | ||
| Taxanes | 14 (93) | 25 (89) |
| Anthracyclines and related substances | 12 (80) | 24 (86) |
| Nitrogen mustard analogues | 13 (87) | 23 (82) |
| Pyrimidine analogues | 5 (33) | 11 (39) |
| Platinum compounds | 4 (27) | 4 (14) |
| Prior hormone therapy | 8 (53) | 19 (68) |
| Prior CDK4/6 inhibitor therapy | — | 2 (7) |
Data shown are n (percentage) of patients, except for median (range).
BEV, bevacizumab; BSA, body surface area; CDK4/6, cyclin-dependent kinase 4/6; CNS, central nervous system; D, day; ECOG, Eastern Cooperative Oncology Group; FOLFIRI, folinic acid, 5-fluorouracil and irinotecan; HR, hormone receptor; MBC, metastatic breast cancer; RD, recommended dose.
a
Includes lung, liver and adrenal glands.
b
These patients received prior therapy in the neoadjuvant and/or the adjuvant settings.
c
This patient received FOLFIRI for 2 months, followed by locoregional administration of a single cycle of mitomycin and then by re-challenge with FOLFIRI plus BEV.