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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

(NCT02468739)

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