Phase III randomized, placebo-controlled, double-blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin-induced peripheral neurotoxicity in stage II/III colorectal cancer
Cancer Medicine Nov 26, 2019
Wang DS, Wang ZQ, Chen G, et al. - Researchers evaluated the effectiveness of GM1 (monosialotetrahexosylganglioside) as a prophylactic against the development of oxaliplatin-induced peripheral neurotoxicity in patients taking oxaliplatin-based chemotherapy for colorectal cancer (CRC). Random allocation of 196 patients having stage II/III CRC undergoing adjuvant chemotherapy with mFOLFOX6 was done to receive intravenous GM1 or a placebo. The rate of grade 2 or worse cumulative neurotoxicity (NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events) was assessed as the primary endpoint. Findings revealed less suffering from the symptoms of acute neuropathy in patients who were treated with GM1. However, the use of GM1 to prevent cumulative neurotoxicity was not supported. In the GM1 and placebo arms, the 3-year disease-free survival rates were estimated to be 85% and 83%, respectively. Between the arms, no differences were seen in toxicity.
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