Major issue in chemotherapy-induced peripheral neuropathy (cipn): lack of standardized measurement scales. ciperinoms study: validity and reliability in cipn assessment

CIPN) is a dose-limiting adverse event of anticancer drugs. A simple and valid method to assess CIPN has not yet been individuated so far; lack of a gold standard measure is still an unmet clinical and scientific need, in particular mandatory to design consistent neuroprotective trials. This study was performed"to select a valid and reproducible outcome measure among existing scales. Patients and methods. These scales were selected to be tested, after a revision of literature and an expert consensus meeting: National Cancer Institute Common-Toxicity-Criteria (NCI-CTC), Total Neuropathy Score (TNSc), modified INCAT sensory sumscore (mISS), European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CIPN20 quality of life measures. Two hundred and eighty-one cancer patients, with a proven stable CIPN and no ongoing chemotherapy, were enrolled at 20 EU/US Centers. Each patient was evaluated twice, every time by two neurologists. Inter- and intra-rater agreement was calculated through K-Cohen coefficients and 95% confidence intervals. Validity tests were performed, through Kruskal-Wallis equality-of-populations rank test, relating mISS and TNSc to NCI-CTC grades. Results. From September 2008 to December 2010, 281 patients affected by colorectal, breast, ovarian, non-small cell lung cancer and multiple myeloma were enrolled. Inter-/intra-observer scores (i.e. r >0.7) were obtained for TNSc, mISS, and NCI-CTC sensory/motor subscales. Test-retest values were high also for EORTC QLQ-C30 and for the CIPN20. Acceptable validity scores were obtained through for mISS and TNSc compared to NCI-CTC (p values 0.04 to <0.001). Conclusions. Proper validity and reliability scores were demonstrated for selected scales. This does not imply that they are all equally reliable in CIPN assessment, since responsiveness issues have not yet been fully investigated. However presented results will help to answer this need, allowing further studies aimed to elect the gold standard measure among those instruments. Subsequently it will be possible to design neuroprotective trials on a solid methodological background.