Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and disabling dose-limiting toxicities of chemotherapy. We report here the results of two separate non-interventional studies (49 patients), which evaluated blood neurofilament light chain (NfL) as a biomarker of CIPN in breast cancer patients treated with paclitaxel. All patients underwent a standard treatment protocol that was established independently of the present studies. NfL was measured in serum using an ultrasensitive single-molecule array and compared with the self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20) and Total Neuropathy Score clinical version (TNSc), a clinician-reported measure of neuropathy progression. The TNSc increased with cumulative dose compared with baseline, and the NfL concentrations were also strongly associated with the cumulative dose of chemotherapy. The analysis showed a correlation between TNSc and NfL. Both TNSc and NfL showed weak to moderate associations with CIPN20 subscores, with a better association for the CIPN20 sensory compared with motor and autonomic subscores. Data from the two studies provide evidence that serum NfL has the potential to be used as a biomarker to monitor and mitigate CIPN. However, studies with additional patients planned in the ongoing clinical trial will determine the universal application of NfL as a biomarker in CIPN.
化疗诱导的周围神经病变是化疗最常见且致残性的剂量限制性毒性反应之一。本文报告两项独立非干预性研究（共49例患者）的结果，这些研究评估了血液神经丝轻链作为紫杉醇治疗乳腺癌患者发生化疗诱导周围神经病变的生物标志物。所有患者均接受独立于本研究的标准化治疗方案。采用超灵敏单分子阵列技术检测血清神经丝轻链水平，并与患者自评的欧洲癌症研究与治疗组织生活质量问卷-化疗诱导周围神经病变二十项量表及临床医生评估的神经病变进展指标——总神经病变评分临床版进行比较。结果显示，总神经病变评分临床版随累积剂量增加而较基线升高，神经丝轻链浓度也与化疗累积剂量呈强相关。分析表明总神经病变评分临床版与神经丝轻链存在相关性。总神经病变评分临床版和神经丝轻链与化疗诱导周围神经病变二十项量表各子评分均呈弱至中度相关，其中与感觉子评分的相关性优于运动和自主神经子评分。两项研究数据证明，血清神经丝轻链具有作为监测和缓解化疗诱导周围神经病变生物标志物的潜力。然而，正在进行的临床试验计划纳入更多患者进行研究，这将最终确定神经丝轻链作为化疗诱导周围神经病变生物标志物的普适性。
肿瘤(癌症)患者之家