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

TABLE 2.

Outcomes of representative clinical trials of oxazaphosphorines 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
Ifosfamide 3 g/m2/d1–3/3w 2007 Phase III trial First-line 109 5.5 2.2 10.9 Lorigan et al. (2007)
Ifosfamide 9 g/m2/3 days continuous infusion/3w 2007 Phase III trial First-line 107 8.4 3.0 10.9 Lorigan et al. (2007)
Ifosfamide 5 g/m2/d1/3w 2002 Phase II trial 1–2 line 49 10 2.6 12 van Oosterom et al. (2002)
Ifosfamide 3 g/m2/d1–3/3w 2002 Phase II trial 1–2 line 49 25 3.3 10 van Oosterom et al. (2002)
Ifosfamide 12 g/m2/3-day continuous infusion/4w 2000 Phase II trial 1–2 line 114 16 3.5 12.8 Nielsen et al. (2000b)
Ifosfamide 2 g/m2/d1–4/3w 1989 Phase II trial First-line 110 24 - 7.2 Antman et al. (1989)
Ifosfamide 5 g/m2/d1/3w 1987 Phase II trial First-line 68 18 - - Bramwell et al. (1987)
Trofosfamide 300 mg/d on days 1–7, then 150 mg/d continuously 2020 Phase II trial First-line 80 6.6 2.8 12.3 Hartmann et al. (2020)
Cyclophosphamide 1.5 g/m2/d1/3w 1987 Phase II trial First-line 67 8 - - Bramwell et al. (1987)
Combination regimens
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 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 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)
Ifosfamide 2 g/m2/d1–2/3w plus etoposide 100 mg/m2/d1–5/3w plus cisplatin 20 mg/m2/d1–5/3w 2000 Phase II trial First-line 104 46 4.6 8 Pápai et al. (2000)
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)
Ifosfamide 1.5 g/m2/d1–3/3w plus etoposide 600 mg/m2/d1/3w 1997 Phase II trial First-line 86 41 - 19 Saeter et al. (1997)
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 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 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)
Cyclophosphamide 200 mg/d1–7,15–21/4w plus sirolimus 4 mg/d 2012 Phase II trial ≥2 line 48 2 3.4 9.9 Schuetze et al. (2012)

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