title: Measuring Therapy-Induced Peripheral Neuropathy: Preliminary Development and Validation of the Treatment-Induced Neuropathy Assessment Scale.
abstract: Various sensory and motor effects are associated with cancer treatment-induced peripheral neuropathy. The current method for capturing the multifaceted nature of neuropathy includes a combination of objective tests, clinician evaluation, and subjective patient report, an approach that is often not logistically feasible, especially for multisite trials. We report the performance of a brief yet comprehensive, easily administered measure, the Treatment-Induced Neuropathy Assessment Scale (TNAS), for assessing the severity and course of neuropathy across various cancer treatments. Data were derived from 4 longitudinal or cross-sectional patient cohorts (N = 573). Patients with multiple myeloma treated primarily with bortezomib and patients with colorectal cancer receiving oxaliplatin evaluated candidate items. Cognitive debriefing showed that all items were easy to understand, and this preliminary TNAS demonstrated reliability, validity, and sensitivity. Numbness/tingling was the most severe item, regardless of therapeutic agent. Although numbness and general pain were moderately correlated, patients perceived them as distinct. Most TNAS items were more severe at follow-up, demonstrating the sensitivity of the instrument to accumulating dose. The TNAS will be refined with further patient input, with final psychometric evaluation conducted in a new patient sample receiving treatments known to be associated with peripheral neuropathy. The nonpainful component of neuropathy may be more disabling than the pain component.
  
  
  CONCLUSIONS
  Our data suggest that the nonpainful components of neuropathy may be more disabling than the pain component during cancer treatment. Here we report data on sensory and motor symptoms reported by patients receiving neurotoxic cancer therapy, and we detail the development of a neuropathy assessment scale that follows regulatory guidance for patient-reported outcomes.
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: tmendoza@mdanderson.org.
authors.forename: Tito R
authors.initials: TR
authors.lastname: Mendoza
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Xin Shelley
authors.initials: XS
authors.lastname: Wang
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Loretta A
authors.initials: LA
authors.lastname: Williams
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Qiuling
authors.initials: Q
authors.lastname: Shi
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Elisabeth G
authors.initials: EG
authors.lastname: Vichaya
authors.affiliation: Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Dougherty
authors.affiliation: Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Sheeba K
authors.initials: SK
authors.lastname: Thomas
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Emre
authors.initials: E
authors.lastname: Yucel
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Christel C
authors.initials: CC
authors.lastname: Bastida
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Jeanie F
authors.initials: JF
authors.lastname: Woodruff
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Charles S
authors.initials: CS
authors.lastname: Cleeland
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000633:toxicity; D000069286:Bortezomib / Q000633:toxicity; D016000:Cluster Analysis; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000633:toxicity; D000077150:Oxaliplatin; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000069286:Bortezomib
keywords: Neuropathy; colorectal cancer; multiple myeloma; patient-reported outcomes; validation