The National Cancer Institute Clinical Trials Planning Meeting for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy.

Author(s): Dorsey SG,  Kleckner IR,  Barton D,  Mustian K,  O'Mara A,  St Germain D,  Cavaletti G,  Danhauer SC,  Hershman DL,  Hohmann AG,  Hoke A,  Hopkins JO,  Kelly KP,  Loprinzi CL,  McLeod HL,  Mohile S,  Paice J,  Rowland JH,  Salvemini D,  Segal RA,  Smith EL,  Stevens WM,  Janelsins MC

Journal: J Natl Cancer Inst

Date: 2019 Jun 1

Major Program(s) or Research Group(s): COPTRG, NCORP

PubMed ID: 30715378

PMC ID: not available

Abstract: 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.