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Table 1 Characteristics of included studies

From: Ganglioside-monosialic acid (GM1) for prevention of chemotherapy-induced peripheral neuropathy: a meta-analysis with trial sequential analysis

Study study design Type of malignancy Chemotherapy regimen Participants GM1 regimen Controls Mean cumulative dose of chemotherapy (GM1 vs. control) Endpoints Study Duration
age, yr (mean/median) age range GM1 Control
Chen et al., 2012 Retrospective colorectal cancer mFOLFOX6, FOLFOX4, XELOX 53.5 (median) 36–75 114 164 40 mg*4/cycle None oxaliplatin, 1120 vs. 960 mg/m2 CIPN (CTCAE); RECIST; CD 24.6 months follow-up
Zhu et al., 2013 RCT gastrointestinal cancer FOLFOX4, XELOX 54.96 (mean) 21–74 60 60 100 mg*3/cycle None oxaliplatin, 692.08 vs. 740.83 mg/m2 CIPN (CTCAE); RECIST over 3 months after chemotherapy
Cao et al., 2014 RCT gastrointestinal cancer FOLFOX6, XELOX 56 (median) 31–72 38 30 40 mg*3/cycle Vitamin B12 NR CIPN (DEB-NTC); RECIST; AEs >12w
Su et al., 2020
RCT (multicenter) breast cancer EC-P, EC-D, DC 44.5 (median) 23–74 103 103 80 mg*3/cycle Placebo paclitaxel, 942.67 vs. 954.29 mg/m2; Docetaxel, 525.31 vs. 501.81 mg/m2 CIPN (CTCAE); AEs 12 months after completion of chemotherapy
Wang et al., 2020 (NCT02251977) RCT (multicenter) colorectal cancer mFOLFOX6, XELOX 52.6 (mean) >  18 98 98 80 mg*5/cycle Placebo NR CIPN (CTCAE, DEB-NTC); AEs; CD 48 months after chemotherapy
  1. AEs Adverse events, CD Chemotherapy dropout, CIPN Chemotherapy-induced peripheral neuropathy, CTCAE Common terminology criteria for adverse events, DC Docetaxel and cyclophosphamide, DEB-NTC Neurotoxicity criteria of Debiopharm, EC-P, Epirubicin and cyclophosphamide followed by paclitaxel, EC-D Epirubicin and cyclophosphamide followed by docetaxel, mFOLFOX6 Modified FOLFOX6, NR Not reported, RCT Randomized controlled trial, RECIST Response evaluation criteria in solid tumors