Table 4.
Secondary chemotherapy for advanced or recurrent uLMS (phase 2 trial).
| Regimen | Year | Patients (n) | LMS (n) | uLMS (n) | ORR (%) | mPFS (Months) | mOS (Months) |
|---|---|---|---|---|---|---|---|
| PTX [39] | 2003 | 48 | 48 | 48 | 8.4 | NA | NA |
| GEM [40] | 2004 | 42 | 42 | 42 | 20.5 | NA | NA |
| GD [30] | 2008 | 48 | 48 | 48 | 27 * | 6.7 | 14.7 |
| GEM vs. GD [29] | 2012 | 90 | 90 | 46 ** | 19 vs. 24 | 5.5 vs. 4.7 | NA |
| Ixabepilone [41] | 2014 | 23 | 23 | 23 | 0 | 1.4 | NA |
| Letrozole [31] | 2014 | 27 | 27 | 27 | 0 | 3 (PFS-12W 50% *) | NA |
| Nivolumab [32] | 2017 | 12 | 12 | 12 | 0 | 1.8 | NA |
| Alisertib [33] | 2017 | 23 | 23 | 23 | 0 | 1.7 | 14.5 |
| Trabectedin [42] | 2018 | 168 | 168 | 168 | 23.5 | 4.1 (PFS-6M 35.2% *) | 20.6 |
| Thalidomide [43] | 2007 | 29 | 29 | 29 | 0 | 1.9 | 8.3 |
| Sunitinib [34] | 2009 | 23 | 23 | 23 | 8.7 | 1.54 | 15.1 |
* Superior to the alternative rate of primary end point in the trial. ** An independent randomized phase 2 trial for uterine leiomyosarcoma and nonuterine leiomyosarcoma. uLMS, uterine leiomyosarcoma; n, number; LMS, leiomyosarcoma; ORR, objective response rate; mPFS, median progression-free survival; mOS, median overall survival; NA, not available; PTX, paclitaxel; GEM, gemcitabine; GD, gemcitabine + docetaxel, PFS-12W, progression-free survival rate at 12 weeks after study entry; PFS-6M, progression-free survival rate at 6 months after study entry.