Table 2.
Studies of Novel Agents in the Treatment of Metastatic Soft Tissue Sarcoma in Adults
| Study | Design | Regimen | Median PFS | Median OS | Response Rates |
|---|---|---|---|---|---|
| Tap et al.35 | Phase 1b/2, randomized, open-label | Olaratumab 15 mg/kg IV days 1 and 8 and doxorubicin 75 mg/m2 day 1 every 21 days | 6.6 months | 26.5 months | ORR, 18.2% |
| Kawai et al.42 | Phase 2, randomized, open-label | Trabectedin 1.2 mg/m2 CIVI over 24 hours every 21 days | 5.6 months | Not reached | PR, 8% SD, 57% |
| Demetri et al.43 | Phase 3, randomized, open-label, active-controlled | Trabectedin 1.5 mg/m2 CIVI over 24 hours every 21 days | 4.2 months | 12.4 months | ORR, 9.9% SD, 51% |
| Schöffski et al.45 | Phase 3, randomized, open-label, active-controlled | Eribulin 1.4 mg/m2 IV days 1 and 8 every 21 days | 2.6 months | 13.5 months | PR, 4% SD, 52% |
| PALETTE47 | Phase 3, randomized, double-blind, placebo-controlled | Pazopanib 800 mg orally daily | 4.6 months | 12.5 months | PR, 6% SD, 67% |
| REGOSARC49 | Phase 2, randomized, double-blind, placebo-controlled | Regorafenib 160 mg orally daily for 21 days on and 7 days off | LMS: 3.7 months SS: 5.6 months |
LMS: 21 months SS: 13.4 months |
LMS: PR, 0%; SD, 86% SS: PR, 8%; SD, 77% |
CIVI = continuous IV infusion; IV = intravenous; LMS = leiomyosarcoma; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; PR = partial response; SD = stable disease; SS = synovial sarcoma.