Table 4.
Study | Soft tissue sarcoma subtype | n | CR | PR | SD | PD | NE | ORR (%) | DCR (%) | 12-week PFS (%) | Median PFS (months) | Median OS (months) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Schöffski 2011 (Phase 2), Ref 6 | Adipocytic sarcoma | 32 | 1 | 0 | 18 | 11 | 2 | 3 | 59 | 46.9 | 2.6 | - |
Leiomyosarcoma | 38 | 0 | 2 | 20 | 14 | 2 | 5 | 58 | 31.6 | 2.9 | - | |
Synovial sarcoma | 19 | 0 | 1 | 8 | 9 | 1 | 5 | 47 | 21.1 | 2.6 | - | |
Othersa | 26 | 0 | 1 | 11 | 13 | 1 | 4 | 46 | 19.2 | 2.1 | - | |
Kawai 2017 (Phase 2), Ref 14 | L-sarcoma | 35 | 0 | 0 | 28 | 7 | 0 | 0 | 80 | 60 | 5.5 | - |
Non-L-typeb | 16 | 0 | 0 | 8 | 8 | 0 | 0 | 50 | 31 | 2.0 | - | |
Schöffski 2016 (Phase 3), Ref 8 | L-sarcoma | 228 | 4 | 56 | 33 | 2.6 | 13.5 | |||||
Liposarcoma | 71 | - | - | - | - | 15.6 | ||||||
Leiomyosarcoma | 157 | - | - | - | - | 12.7 | ||||||
Demetri 2017 (Phase 3 sub-analysis), Ref 9 | Liposarcoma | 71 | 1.4 | 66.2 | 41 | 2.9 | 15.6 | |||||
Myxoid/round cell | 29 | - | - | - | 2.8 | 13.5 | ||||||
Pleomorphic | 11 | - | - | - | 4.4 | 22.2 | ||||||
Dedifferentiated | 31 | - | - | - | 2.0 | 18.0 |
aAchieved 12-week PFS and included fibroblastic sarcoma (n = 2), solitary fibrous tumor (n = 1), and epithelioid sarcoma (n = 2).
bAchieved 12-week PFS and included synovial sarcoma (n = 1), endometrial stromal sarcoma (n = 2), fibrosarcoma (n = 1), and solitary fibrous tumor (n = 1).
Abbreviations: CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable; ORR, overall response rate; DCR, disease control rate; PFS, progression-free survival; OS, overall survival.L-sarcoma consists of liposarcoma and leiomyosarcoma.