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. 2023 Aug 11;14:1199292. doi: 10.3389/fphar.2023.1199292

TABLE 1.

Outcomes of representative clinical trials of anthracyclines in nonspecific STSs.

Drugs and dosages Years of report Study types Setting Number of patients Outcomes References
ORR (%) M-PFS (months) M-OS (months)
Single agent
Doxorubicin 75 mg/m2/d1/3w 2020 Phase III trial Anthracycline-naive 251 18.3 6.8 19.7 Tap et al. (2020)
Doxorubicin 60 mg/m2/d1/3w 2020 Phase II trial First-line 40 7.7 4.3 9.8 Hartmann et al. (2020)
Doxorubicin 75 mg/m2/d1/3w 2020 Phase II trial First-line 39 15.4 5.3 14.3 Grünwald et al. (2020)
Doxorubicin 75 mg/m2/d1/3w 2017 Phase III trial First-line 323 18 6.0 19.0 Tap et al. (2017)
Doxorubicin 75 mg/m2/d1/3w 2017 Phase III trial First-line 129 20 5.4 17.9 Seddon et al. (2017)
Doxorubicin 75 mg/m2/d1/3w 2016 Phase II trial Anthracycline-naive 65 11.9 4.1 14.7 Tap et al. (2016)
Doxorubicin 75 mg/m2/d1/3w 2016 Phase III trial First-line 221 19.9 5.2 16.9 Ryan et al. (2016)
Doxorubicin 75 mg/m2/d1/3w 2016 Phase II trial First-line 59 17 5.5 13.7 Martin-Broto et al. (2016)
Doxorubicin 75 mg/m2/d1/3w 2015 Phase II trial First-line 40 5 4.6 14.3 Chawla et al. (2015)
Doxorubicin 75 mg/m2/d1/3w 2014 Phase III trial First-line 228 14 4.6 12.8 Judson et al. (2014)
Doxorubicin 75 mg/m2/d1/3w 2009 Phase II trial First-line 64 23.4 6.5 - Maurel et al. (2009)
Doxorubicin 75 mg/m2/d1/3w 2007 Phase III trial First-line 110 11.8 2.5 12.0 Lorigan et al. (2007)
Doxorubicin 75 mg/m2/d1/3w 2001 Phase II trial First-line 44 7 2.7 8.2 Judson et al. (2001)
Doxorubicin 75 mg/m2/d1/3w 1998 Phase III trial First-line 104 14 3.7 10.5 Nielsen et al. (1998)
Doxorubicin 75 mg/m2/d1/3w 1995 Phase III trial First-line 263 23.3 10.7 12.1 Santoro et al. (1995)
Doxorubicin 70 mg/m2/d1/3w 1990 Phase III trial First-line 151 17 3 9.4 Borden et al. (1990)
Doxorubicin 70 mg/m2/d1/3w 1987 Phase III trial First-line 83 25 3.5 9.6 Mouridsen et al. (1987)
Aldoxorubicin 350 mg/m2/d1/3w 2015 Phase II trial First-line 83 23 8.3 15.8 Chawla et al. (2015)
Pegylated liposomal doxorubicin 50 mg/m2/d1/4w 2001 Phase II trial First-line 50 10 2.2 10.7 Judson et al. (2001)
Epirubicin 150 mg/m2/d1/3w 1998 Phase III trial First-line 106 15 3.3 11.0 Nielsen et al. (1998)
Epirubicin 50 mg/m2/d1–3/3w 1998 Phase III trial First-line 106 14 2.8 10.5 Nielsen et al. (1998)
Epirubicin 75 mg/m2/d1/3w 1987 Phase III trial First-line 84 18 2.8 11.2 Mouridsen et al. (1987)
Combination regimens
Doxorubicin 75 mg/m2/d1/3w plus olaratumab 20 mg/kg/d1,8/3w in cycle 1, and 15 mg/kg in subsequent cycles 2020 Phase III trial First-line 258 14 5.4 20.4 Tap et al. (2020)
Doxorubicin 75 mg/m2/d1/3w plus evofosfamide 300 mg/m2/d1, 8/3w 2017 Phase III trial First-line 317 28 6.3 18.4 Tap et al. (2017)
Doxorubicin 75 mg/m2/d1/3w plus olaratumab 20 mg/kg/d1, 8/3w 2016 Phase II trial First-line 65 18.2 6.6 16.5 Tap et al. (2016)
Doxorubicin 75 mg/m2/d1/3w plus palifosfamide 150 mg/m2/d1–3/3w 2016 Phase III trial First-line 226 28.3 6.0 15.9 Ryan et al. (2016)
Doxorubicin 60 mg/m2/d1/3w plus trabectedin 1.1 mg/m2/d1/3w 2016 Phase II trial First-line 54 17 5.7 13.3 Martin-Broto et al. (2016)
Doxorubicin 25 mg/m2/d1–3/3w plus ifosfamide 2.5 g/m2/d1-4/3w 2014 Phase III trial First-line 228 26 7.4 14.3 Judson et al. (2014)
Doxorubicin 30 mg/m2/d1–3/2w for 3 cycles followed by ifosfamide 2.5 g/m2/d1-5/3w for 3 cycles 2009 Phase II trial First-line 62 24.1 6.0 - Maurel et al. (2009)
Doxorubicin 20 mg/m2/d1–3/3w plus ifosfamide 2.5 g/m2/d1–3/3w plus dacarbazine 300 mg/m2/d1–3/3w 2009 Phase III trial First-line 74 35 9.8 17.7 Fayette et al. (2009)
Doxorubicin 25 mg/m2/d1–3/3w plus ifosfamide 3 g/m2/d1–3/3w plus dacarbazine 400 mg/m2/d1–3/3w 2009 Phase III trial First-line 71 38 9.1 17.3 Fayette et al. (2009)
Doxorubicin 30 mg/m2/d1–3/2w for 3 cycles followed by ifosfamide 2.5 g/m2/d1–5/3w for 3 cycles 2004 Phase II trial First-line 57 38 5.6 13.5 Maurel et al. (2004)
Pegylated liposomal doxorubicin 45 mg/m2/d1/3w plus paclitaxel 150 mg/m2/d1/3w 2004 Phase II trial First-line 42 16 5.7 13.2 Bafaloukos et al. (2004)
Doxorubicin 50 mg/m2/d1/3w plus ifosfamide 5 g/m2/d1/3w 2000 Phase III trial First-line 149 21 11.0 13.1 Le Cesne et al. (2000)
Doxorubicin 75 mg/m2/d1/3w plus ifosfamide 5 g/m2/d1/3w 2000 Phase III trial First-line 145 23.3 8.6 12.8 Le Cesne et al. (2000)
Doxorubicin 50 mg/m2/d1/3w plus ifosfamide 5 g/m2/d1/3w 1995 Phase III trial First-line 258 28.1 10.3 12.8 Santoro et al. (1995)
Cyclophosphamide 500 mg/m2/d1/3w plus vincristine 1.5 mg/m2/d1/3w plus doxorubicin 50 mg/m2/d1/3w plus dacarbazine 750 mg/m2/d1/3w 1995 Phase III trial First-line 142 28.4 11.2 11.9 Santoro et al. (1995)
Doxorubicin 60 mg/m2/d1/3w plus dacarbazine 1,000 mg/m2/d1/3w 1993 Phase III trial First-line 170 17 4 12 Antman et al. (1993)
Doxorubicin 60 mg/m2/d1/3w plus dacarbazine 1,000 mg/m2/d1/3w plus ifosfamide 5–7.5 g/m2/d1–3/3w 1993 Phase III trial First-line 170 32 6 13 Antman et al. (1993)
Doxorubicin 70 mg/m2/d1/3w plus vindesine 3 mg/m2/d1/3w 1990 Phase III trial First-line 147 18 4 9.9 Borden et al. (1990)
Doxorubicin 60 mg/m2/d1/3w plus ifosfamide 5 g/m2/d1/3w 1989 Phase II trial First-line 42 36 7 8 Loehrer et al. (1989)
Doxorubicin 60 mg/m2/d1/3w plus dacarbazine 900 mg/m2/d1/3w plus ifosfamide 7.5 g/m2/d1/3w 1989 Phase II trial First-line 105 47 9.5 16 Elias et al. (1989)
Doxorubicin 60 mg/m2/d1/3w plus dacarbazine 250 mg/m2/d1/3w 1987 Phase III trial First-line 104 33 7.2 8.6 Baker et al. (1987)
Doxorubicin 60 mg/m2/d1/3w plus dacarbazine 250 mg/m2/d1/3w plus cyclophosphamide 500 mg/m2/d1/3w 1987 Phase III trial First-line 112 34 6.0 9.8 Baker et al. (1987)
Doxorubicin 60 mg/m2/d1/3w plus dacarbazine 250 mg/m2/d1/3w plus actinomycin D 1.2 mg/m2/d1/3w 1987 Phase III trial First-line 119 24 5.4 11.7 Baker et al. (1987)

STSs, soft tissue sarcomas; ORR, objective response rate; M-PFS, median progression-free survival time; M-OS, median overall survival.