Phase III randomized, placebo‐controlled, double‐blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin‐induced peripheral neurotoxicity in stage II/III colorectal cancer

Autor: Fen Feng, Yu Hong Li, Wen hua Fan, Wei Wang, Zhen Hai Lu, Feng Wang, Rui-Hua Xu, Si mei Shi, Ying Jin, Zhi Qiang Wang, Feng Hua Wang, Pei-Rong Ding, Han lin Liang, De Shen Wang, Gong Chen, Yan Hong Deng, Chao Ren, Chuan bo Xie, Jianwei Zhang, Jie wen Peng
Jazyk: angličtina
Rok vydání: 2020
Předmět:
0301 basic medicine
Male
Cancer Research
Organoplatinum Compounds
Oxaloacetates
medicine.medical_treatment
GM1
Leucovorin
Gastroenterology
Severity of Illness Index
Placebos
0302 clinical medicine
FOLFOX
Antineoplastic Combined Chemotherapy Protocols
neurotoxicity
Clinical endpoint
Original Research
Peripheral Nervous System Diseases
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Oncology
030220 oncology & carcinogenesis
Female
Fluorouracil
medicine.symptom
Colorectal Neoplasms
medicine.drug
Adult
medicine.medical_specialty
colorectal cancer
G(M1) Ganglioside
Placebo
lcsh:RC254-282
Disease-Free Survival
03 medical and health sciences
Double-Blind Method
Internal medicine
OIPN
medicine
Humans
Radiology
Nuclear Medicine and imaging
Adverse effect
Capecitabine
Neoplasm Staging
EORTC QLQ‐CIPN20
Chemotherapy
Dose-Response Relationship
Drug
business.industry
oxaliplatin
Neurotoxicity
Clinical Cancer Research
medicine.disease
Oxaliplatin
030104 developmental biology
EORTCQLQ‐CIPN20
business
Muscle cramp
Zdroj: Cancer Medicine, Vol 9, Iss 1, Pp 151-159 (2020)
Cancer Medicine
ISSN: 2045-7634
Popis: Background Monosialotetrahexosylganglioside (GM1) is a neuroprotective glycosphingolipid that repairs nerves. Oxaliplatin‐based chemotherapy is neurotoxic. This study assessed the efficacy of GM1 for preventing oxaliplatin‐induced peripheral neurotoxicity (OIPN) in colorectal cancer (CRC) patients receiving oxaliplatin‐based chemotherapy. Methods In total, 196 patients with stage II/III CRC undergoing adjuvant chemotherapy with mFOLFOX6 were randomly assigned to intravenous GM1 or a placebo. The primary endpoint was the rate of grade 2 or worse cumulative neurotoxicity (NCI‐CTCAE). The secondary endpoints were chronic cumulative neurotoxicity (EORTC QLQ‐CIPN20), time to grade 2 neurotoxicity (NCI‐CTCAE or the oxaliplatin‐specific neuropathy scale), acute neurotoxicity (analog scale), rates of dose reduction or withdrawal due to OIPN, 3‐year disease‐free survival (DFS) and adverse events. Results There were no significant differences between the arms in the rate of NCI‐CTCAE grade 2 or worse neurotoxicity (GM1: 33.7% vs placebo: 31.6%; P = .76) or neuropathy measured by the EORTC QLQ‐CIPN20 or time to grade 2 neurotoxicity using NCI‐CTCAE and the oxaliplatin‐specific neuropathy scale. GM1 substantially decreased participant‐reported acute neurotoxicity (sensitivity to cold items [P
Neuropathy is the most prominent dose‐limiting toxicity of oxaliplatin. Patients receiving Monosialotetrahexosylganglioside (GM1) were less troubled by the symptoms of acute neuropathy. However, we do not support the use of GM1 to prevent cumulative neurotoxicity.
Databáze: OpenAIRE
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