Trial reportCancer chemotherapy and pharmacology2026
Longitudinal plasma phosphorylated neurofilament-heavy chain levels in oxaliplatin-induced peripheral neuropathy: a prospective multi-institutional exploratory study.
Trial report in Cancer chemotherapy and pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeReliable circulating biomarkers for chemotherapy-induced peripheral neuropathy (CIPN) remain lacking. Phosphorylated neurofilament-heavy chain (pNF-H) is an axon-oriented biomarker of neuroaxonal injury, but its clinical relevance in oxaliplatin-induced peripheral neuropathy has not been established. We evaluated the feasibility and longitudinal behavior of plasma pNF-H in patients receiving oxaliplatin-based chemotherapy.
methodsThis prospective multi-institutional exploratory study included patients with unresectable or recurrent colorectal cancer receiving CapeOX plus bevacizumab as part of the NYX study, a randomised trial of ninjin'yoeito (NYT; TJ-108, Tsumura & Co., Tokyo, Japan), a twelve-ingredient Kampo herbal extract, at 9.0 g/day for 24 weeks in the NYT arm. Plasma samples were collected at baseline, at clinically assessed CIPN onset (follow-up 1), and at the time of neuropathy resolution, at cycle 9, or at discontinuation, whichever came first (follow-up 2). Plasma pNF-H concentrations were measured by enzyme-linked immunosorbent assay. CIPN was assessed using CTCAE version 5.0.
resultsThirty patients with evaluable plasma samples were included. Plasma pNF-H levels showed substantial inter-individual variability without a consistent temporal pattern. Compared with baseline and CIPN onset, plasma pNF-H levels at follow-up 2 were modestly but significantly increased. However, plasma pNF-H levels were not associated with the onset, severity, or persistence of clinically assessed CIPN.
conclusionsAlthough longitudinal plasma pNF-H measurement was technically feasible, pNF-H did not function as a clinically meaningful biomarker for oxaliplatin-induced peripheral neuropathy. These findings may reflect a pathophysiological mismatch between dorsal root ganglion neuronal cell body injury and the axon-oriented biological specificity of pNF-H.
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