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

TABLE 5.

Outcomes of representative clinical trials of gemcitabine 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
Gemcitabine 1,200 mg/m2/d1,8/3w 2007 Phase II trial Any-line 49 8 3 11.5 Maki et al. (2007)
Gemcitabine 1,000 mg/m2/1w 2006 Phase II trial First-line 46 7 2 6 Von Burton et al. (2006)
Gemcitabine 1,250 mg/m2/d1,8,15/4w 2003 Phase II trial Any-line 25 4 - 15 Okuno et al. (2003)
Gemcitabine 1,250 mg/m2/d1,8/3w 2002 Phase II trial ≥2 line 31 3.23 1.5 8.9 Svancárová et al. (2002)
Combination regimens
Gemcitabine 1,000 mg/m2/d1,8/3w plus pazopanib 800 mg/d 2021 Phase II trial ≥2 line 45 11 4.1 12.4 Somaiah et al. (2021)
Gemcitabine 900 mg/m2/d1,8/3w plus docetaxel 100 mg/m2/d8/3w 2021 Phase II trial ≥2 line 45 18 4.1 15.9 Somaiah et al. (2021)
Gemcitabine 1,000 mg/m2/d1,8/3w plus pazopanib 800 mg/d 2021 Phase II trial ≥2 line 43 11 5.6 13.1 Schmoll et al. (2021)
Gemcitabine 900 mg/m2/d1,8/3w plus docetaxel 75 mg/m2/d8/3w 2019 Phase II trial Any-line 70 20 5.6 21.1 Jones et al. (2019)
Gemcitabine 675 mg/m2/d1,8/3w plus docetaxel 75 mg/m2/d8/3w 2017 Phase III trial First-line 128 20 5.5 15.7 Seddon et al. (2017)
Gemcitabine 1,000 mg/m2/d1,8/3w plus docetaxel 35 mg/m2/d1,8/3w 2012 Phase II trial ≥2 line 30 16.7 2.5 8.4 Lee et al. (2012)
Gemcitabine 1800 mg/m2/3w plus dacarbazine 500 mg/m2/2w 2011 Phase II trial ≥2 line 57 12 4.2 16.8 Garcia-Del-Muro et al. (2011)
Gemcitabine 800 mg/m2/d1,8/3w plus vinorelbine 25 mg/m2/d1,8/3w 2007 Phase II trial Any-line 40 10 3.4 - Dileo et al. (2007)

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