In:
Cancer Medicine, Wiley, Vol. 9, No. 1 ( 2020-01), p. 151-159
Abstract:
Monosialotetrahexosylganglioside ( GM 1) 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 m FOLFOX 6 were randomly assigned to intravenous GM 1 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 ‐ CIPN 20), 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 ( GM 1: 33.7% vs placebo: 31.6%; P = .76) or neuropathy measured by the EORTC QLQ ‐ CIPN 20 or time to grade 2 neurotoxicity using NCI ‐ CTCAE and the oxaliplatin‐specific neuropathy scale. GM 1 substantially decreased participant‐reported acute neurotoxicity (sensitivity to cold items [ P 〈 .01], discomfort swallowing cold liquids [ P 〈 .01], throat discomfort [ P 〈 .01], muscle cramps [ P 〈 .01]). The rates of dose reduction or withdrawal were not significantly different between the arms ( P = .08). The 3‐year DFS rates were 85% and 83% in the GM 1 and placebo arms, respectively ( P = .19). There were no differences in toxicity between the arms. Conclusion Patients receiving GM 1 were less troubled by the symptoms of acute neuropathy. However, we do not support the use of GM 1 to prevent cumulative neurotoxicity. ( ClinicalTrials.gov number, NCT02251977).
Type of Medium:
Online Resource
ISSN:
2045-7634
,
2045-7634
Language:
English
Publisher:
Wiley
Publication Date:
2020
detail.hit.zdb_id:
2659751-2
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