Table 1.
List of published sarcoma clinical trials on ET-743
| Study | Regimen | n | RR (RECIST) | PFS (months) | OS (months) |
|---|---|---|---|---|---|
| Pretreated | |||||
| Delaloge et al36 (phase I + compassionate use) | ET-743 24 hr CIV | 29 | PR 14% | 2.8 | NR |
| 1.2 mg/m2 (n = 6) | (LMS 28%, liposarcoma 14%) | MR 7% | |||
| 1.5 mg/m2 (n = 22) | SD 34% | ||||
| 1.8 mg/m2 (n = 1) | |||||
| Yovine et al37 (phase II) | ET-743 24 hr CIV | 54 | PR 4% | 1.9 | 12.8 |
| 1.5 mg/m2 | (LMS 41%, liposarcoma 11%) | MR 7% | |||
| SD 17% | |||||
| Garcia-Carbonero et al38 (phase II) | ET-743 24 hr CIV | 36 | CR 3% | 1.7 | 12.1 |
| 1.5 mg/m2 | (LMS 36%, liposarcoma 28%) | PR 5% | |||
| MR 5% | |||||
| Le Cesne et al39 (phase II) | ET-743 24 hr CIV | 104 | PR 8% | 3.4 | 9.2 |
| 1.5 mg/m2 | (LMS 41%, liposarcoma 10%) | SD 43% | |||
| Huygh et al40 (phase II + compassionate use) | ET-743 24 hr CIV | 89 | CR 1% | 2.0 | 8.25 |
| 0.9–1.5 mg/m2 | (LMS 33%, liposarcoma 18%) | PR 6% | |||
| MR 1% | |||||
| SD 18% | |||||
| Demetri et al43 (randomized phase II in L-type sarcomas) | A: 0.58 mg/m2 IV | 270 | A: | A: 2.3 | A: 11.8 |
| over 3 hrs weekly | A: 136 | 1.6% PR | B: 3.3 | B: 13.9 | |
| B: 1.5 mg/m2 CIV | B: 134 | B: | P = 0.0418 | P = 0.19 | |
| over 24 hrs every 3 wks | (65.6% LMS and 34.4% liposarcomas) | 5.6% PR | |||
| Front line | |||||
| Garcia-Carbonero et al41 (phase II) | ET-743 24 hr CIV | 36 | CR 3% | 1.6 | 15.8 |
| 1.5 mg/m2 | (LMS 42%, liposarcoma 25%) | PR 14% | |||
| MR 3% | |||||
Abbreviations: LMS, leiomyosarcoma; RECIST, Response Evaluation Criteria in Solid Tumors; RR, response rate; PFS, progression-free survival; OS, overall survival; CIV, continuous infusion; PR, partial response; MR, minor response; SD, stable disease; CR, complete response; IV, intravenous.