Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Center to Advance Chronic Pain Research, Baltimore, MD.
Department of Surgery, University of Rochester Medical Center, Cancer Control Program, Wilmot Cancer Institute, Rochester, NY.
J Natl Cancer Inst. 2019 Jun 1;111(6):531-537. doi: 10.1093/jnci/djz011.
Although recent scientific advances have improved our understanding of basic biological mechanisms underlying chemotherapy-induced peripheral neuropathy (CIPN), few interventions are available to prevent or treat CIPN. Although some biological targets from preclinical studies show promise in nonhuman animal models, few targets have been translated to successful clinical trials. To address this problem, the National Cancer Institute's Symptom Management and Health-Related Quality of Life Steering Committee convened a meeting of experts in the CIPN and oncology symptom management fields to participate in a Clinical Trials Planning Meeting (CTPM). Investigators presented data from preclinical and translational studies for possible CIPN interventions; these were evaluated for readiness of randomized clinical trial testing by experts, and recommendations were provided. Breakout sessions were convened to discuss and develop future studies. The CTPM experts concluded that there is compelling evidence to move forward with selected pharmacological and nonpharmacological clinical trials for the prevention and treatment of CIPN. Several key feasibility issues need to be addressed, however. These include identification of optimal outcome measures to define the CIPN phenotype, establishment of parameters that guide the evaluation of clinically meaningful effects, and adoption of approaches for inclusion of translational and biomarker and/or genetic measures. The results of the CTPM provide support for conducting clinical trials that include both pharmacological and nonpharmacological approaches, alone or in combination, with biomarkers, genetics, or other measures designed to inform underlying CIPN mechanisms. Several working groups were formed to design rigorous CIPN clinical trials, the results of which are ongoing.
尽管最近的科学进步提高了我们对化疗引起的周围神经病（CIPN）的基础生物学机制的理解，但几乎没有干预措施可用于预防或治疗 CIPN。尽管一些来自临床前研究的生物学靶点在非人类动物模型中显示出前景，但很少有靶点被转化为成功的临床试验。为了解决这个问题，美国国家癌症研究所的症状管理和健康相关生活质量指导委员会召集了 CIPN 和肿瘤症状管理领域的专家会议，参加了临床试验规划会议（CTPM）。研究人员为可能的 CIPN 干预措施展示了临床前和转化研究的数据；这些数据由专家评估进行随机临床试验测试的准备情况，并提供了建议。召开了分组会议，讨论和制定未来的研究计划。CTPM 专家得出结论，有令人信服的证据表明，有必要推进选定的药理学和非药理学临床试验，以预防和治疗 CIPN。然而，还需要解决几个关键的可行性问题。其中包括确定最佳的结果测量来定义 CIPN 表型，建立指导评估临床有意义影响的参数，以及采用纳入转化和生物标志物和/或遗传测量的方法。CTPM 的结果为进行临床试验提供了支持，这些临床试验包括单独或联合使用药理学和非药理学方法，以及生物标志物、遗传学或其他旨在阐明 CIPN 机制的措施。已经成立了几个工作组来设计严格的 CIPN 临床试验，其结果正在进行中。
