Table 1.
Clinical trials of trabectedin (Phase II and III)
| Study design | Patients | Regimen | ORR | Median
|
|
|---|---|---|---|---|---|
| PFS | OS | ||||
| Phase II44 R (1:1) |
LPS or LMS n=270 |
A; T 1.5 mg/m2 24-h q3ws B; T 0.58 mg/m2 3-h weekly |
5.6% 1.6% |
3.7 mos 2.3 mos |
13.9 mos 11.8 mos |
| Phase II41 | STS n=36 |
T 1.5 mg/m2 24-h q3ws | 8% | 1.7 mos | 12.1 mos |
| Phase II65 | STS n=104 |
T 1.5 mg/m2 24-h q3ws | 8% | 3.4 mos | 9.2 mos |
| Phase II42 R (1:1:1) |
STS n=133 |
A; T 1.3 mg/m2 3-h q3ws B; T 1.5 mg/m2 24-h q3ws C; D 75 mg/m2 q3ws |
14.8% 4.7% 25.6% |
2.8 mos 3.1 mos 5.5 mos |
|
| Phase II40 | STS n=54) |
T 1.5 mg/m2 24-h q3ws | 4% | 1.9 mos | 12.8 mos |
| Phase III46 | LPS or LMS n=518 |
A; T 1.5 mg/m2 24-h q3ws B; Dac 1 g/m2 20- to 120-minute q3ws |
9.9% 6.9% |
4.2 mos 1.5 mos |
12.4 mos 12.9 mos |
| Phase II49 R (1:1) |
T-STS n=76 |
A; T 1.2 mg/m2 24-h q3ws B; Best supportive care |
11% 0% |
5.6 mos 0.9 mos |
Not reached 8 mos |
| Phase III55 R (1:1) |
T-STS n=121 |
A; T 1.5 mg/m2 24-h q3ws B; D 75 mg/m2 q3ws or D 60 mg/m2 + I 6–9 g/m2 q3ws |
5.9% 27% |
16.1 mos 8.8 mos |
|
| Phase II53 | STS n=40 |
1.5 mg/m2 24-h q3ws | 2.5% | ||
Abbreviations: R, randomized study; STS, soft tissue sarcoma; A, group A; B, group B; C, group C; T, trabectedin; D, doxorubicin; I, ifosfamide; Dac, dacarbazine; q3ws, every 3 weeks; h, hour; ORR, objective response rate according to Response Evaluation Criteria In Solid Tumors criteria; PFS, progression-free survival; OS, overall survival; mos, months; LPS, liposarcoma; LMS, leiomyosarcoma; T-STS, translocation-related soft tissue sarcoma.