Table 4.
Most relevant prospective trials with systemic agents including uterine sarcoma patients.
| Chemotherapy agents | Inclusion | Phase | N (uLMS) | RR % | PFS (months) | OS (months) | |
|---|---|---|---|---|---|---|---|
| First-line studies | |||||||
| 80Sutton 1996 | Doxo + ifosfamide | uLMS | II | 34 | 30.3 | 4 | – |
| 77Judson 2014 | Doxo versus Doxo + ifosfamide | STS | III | 455 | 14 versus 27 | 4.6 versus 7.4 | 12.8 versus 14.3 |
| (113 LMS) | |||||||
| 78GeDDisSeddon 2017 | Doxo 75 mg/m2 versus gemcitabine 650 mg/m2 d1 & 8 + Docetaxel 75 mg/m2 d8/21 d | STS | III | 257 (71) | – | 23.3 versus 23.7 weeks | 76.3 versus 67.3 weeks |
| 80LMS-04 Pautier ESMO2021 | Doxo 60 mg/m2 + Trabectedin 1.1 mg/m2 iv 3 h/21 d versus Doxo 75 mg/m2 | LMS | III | 150 (67) | 38 versus 13 | 13.5 versus 7.3 | 30.5 versus 24.1 |
| 81Sutton 1996 | Ifosfamide 1.5 mg/m2 d1-5/21 d | ESS | II | 31 | 33 | 3 | – |
| Second and further lines | |||||||
| 85Le Cesne 2005 | Trabectedin 1.5 mg/m2 24 h iv/21 d | STS | II | 104 | 56 (CBR) LMS | PFS 6 m | 9.2 |
| (43 LMS) | 29% | ||||||
| 86Garcia del Muro JCO2011 | DTIC 500 mg/m2+ Gemcitabine 1800 mg/m2 iv/14 d versus DTIC1000 mg/m2/21 d | STS | II | 109 | 12 versus 4 | 4.2 versus 2 | 16.8 versus 8.2 |
| (32 LMS) | |||||||
| 85Hensley 2017 (uLMS post hoc) | Trabectedin 1.5 mg/m2 24 h iv/21 d versus DTIC 1 gr/21 d | LMS and LPS | III | 577 (232) | 11 versus 9 | 4 versus 1.5 | 13.4 versus 12.9 |
| CBR | uLMS | ||||||
| (31 versus 18 uLMS) | uLMS | ||||||
| 86 Le Cesne 2015 | Trabectedin 1.5 mg/m2 24 h/21 d × 6cycles versus continuous | STS | II | 56 (21 LMS) | PFS 6 m | OS 12 m | |
| 23.1 versus 51.9% | 73.3 versus 85.2% | ||||||
| 84Hensley 2008 | Gemcitabine 900 mg/m2 d1 & d8 90 min+ Docetaxel 100 mg/m2 d8/3w | uLMS | II | 51 | 27 | 5.4 | 14.7 |
CBR, clinical benefit rate; DTIC, dacarbazine; ESS, endometrial stromal sarcoma; LMS, leyomiosarcoma; OS, overall survival; PFS, progression-free survival; RR, response rate; STS, soft tissue sarcoma; uLMS, uterine leyomiosarcoma.