Table 3.
Best response according to RECIST in patients with metastatic breast cancer treated with capecitabine plus lurbinectedin
| Schedule |
||||||||
|---|---|---|---|---|---|---|---|---|
| Capecitabine D1-D14/lurbinectedin D1,D8 |
Capecitabine D1-D14/lurbinectedin D1 |
|||||||
| All dose levels (n = 3) |
RD (1650 mg/m2/2.2 mg/m2) (n = 15) |
All dose levels (n = 25) |
All dose levels (n = 28) |
|||||
| n | % | n | % | n | % | n | % | |
| CR | — | — | — | — | 1 | 4 | 1 | 4 |
| PR | 1 | 33 | 7 | 47 | 14 | 56 | 15 | 54 |
| SD ≥4 months | — | — | 3 | 20 | 3 | 12 | 3 | 11 |
| SD <4 months | 1 | 33 | 2 | 13 | 4 | 16 | 5 | 18 |
| PD | 1 | 33 | 3 | 20 | 3 | 12 | 4 | 14 |
| ORR (%) (95% CI) |
33% (0.8% to 90.6%) | 47% (21.3% to 73.4%) | 60% (38.7% to 78.9%) | 57% (37.2% to 75.5%) | ||||
| CBR (%) after 4 monthsa (95% CI) |
33% (0.8% to 90.6%) | 67% (38.4% to 88.2%) | 72% (50.6% to 87.9%) | 68% (47.7% to 84.1%) | ||||
| CBR (%) after 6 monthsb (95% CI) |
33% (0.8% to 90.6%) | 60% (32.3% to 83.7%) | 68% (46.5% to 85.1%) | 64% (44.1% to 84.1%) | ||||
| Median DoR (months) (95% CI) |
12.5 (—) | 6.8 (1.3-NR) | 6.8 (2.4-12.5) | 6.8 (3.4-12.5) | ||||
| Median PFS (months) (95% CI) |
16.9 (1.1-16.9) | 5.5 (1.1-10.2) | 7.3 (3.9-10.2) | 7.3 (3.9-10.2) | ||||
CBR, clinical benefit rate; CI, confidence interval; CR, complete response; D, day; DoR, duration of response; NR, not reached; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; RD, recommended dose; SD, stable disease.
a
Patients with CR + PR + SD ≥4 months.
b
Patients with CR + PR + SD ≥6 months.