Table 3.
Antitumor activity according to RECIST in patients evaluable for efficacy at the recommended dose for phase II studies, with or without BEV
|
Group A (Paclitaxel 80 mg/m2 / lurbinectedin 4.0 mg FD or 2.2 mg/m2) (n = 33) |
Group B (Paclitaxel 80 mg/m2 / lurbinectedin 2.2 mg/m2 / BEV 15 mg/kg) (n = 10) |
|||
|---|---|---|---|---|
| n | % | n | % | |
| CR | 1 | 3 | 1 | 10 |
| PR | 12 | 36 | 4 | 40 |
| SD ≥ 3 mo | 6 | 18 | 4 | 40 |
| SD < 3 mo | 1 | 3 | ||
| PD | 12 | 36 | ||
| Early PD | 1 | 3 | ||
| TF | 1 | 10 | ||
|
ORR (%) (95%CI) |
39% (22.9–57.9%) |
50% (18.7–81.3%) |
||
|
CBR (%) (95%CI) |
58% (39.2–74.5%) |
90% (55.5–99.8%) |
||
|
Median DoR (months) (95%CI) |
4.1 (2.1–8.3) |
4.6 (1.4-n.r.) |
||
BEV bevacizumab, CBR clinical benefit rate, CI confidence interval, CR complete response, D Day, DL dose level, DoR duration of response, FD flat dose, MTD maximum tolerated dose, n.r. not reached, ORR overall response rate, PD progressive disease, PR partial response, q3wk every three weeks, RD recommended dose, RECIST Response Evaluation Criteria In Solid Tumors, SD stable disease, TF treatment failure