Potential use of Pain Vision as an objective method to evaluate chemotherapy-induced peripheral neuropathy.

Abstract

e20557 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting adverse event, but no objective method exists to evaluate CIPN in an easy-to-use and reproducible manner. Pain Vision (PS-2100; Nipro Co., Osaka, Japan) (PV) was developed to quantitatively evaluate peripheral neuropathy using minimum threshold electric current (mTEC) by painless stimulus. PV has been reported useful in evaluating diabetic neuropathy and neuropathic pain induced by other causes. We investigated the usefulness of PV as an objective method to evaluate CIPN. Methods: Breast and ovarian cancer patients, who were intended to receive adjuvant chemotherapy including paclitaxel (PTX), were enrolled in a clinical study to explore SNPs related to CIPN (UMIN000005294). CIPN was prospectively evaluated at baseline, mid-treatment after receiving a total PTX dosage of 480mg/m2 and three weeks following treatment completion using NCI-CTC (v4), FACT-Neurotaxane (FACT-Ntx) and mTEC as measured by PV. Correlations between changes of mTEC readings and NCI-CTC or FACT-Ntx were analyzed using generalized estimating equations. Results: Ninety-four women were enrolled in this study between April 2011 and December 2012, 15 patients had not reached the post-treatment evaluation point at time of this analysis. Median age was 50 years (range, 27-78) and the incidence of CIPN was 99%. No patient had CIPN at baseline. Mid-treatment and post-treatment CIPN grades were 0/1/2/3=9/70/15/0 and 3/41/30/5 using NCI-CTC while median mTEC readings at baseline, mid-treatment and post-treatment points were 7.8 (4.9-19.9), 8.6 (5.1-17.8) and 9.7 (5.3-22.4)μA, respectively. In baseline and post-treatment comparisons, median mTEC reading changes were significantly correlated with every NCI-CTC grade (median mTEC changes for grades 1/2/3=0.39/0.36/0.64; p=0.003/0.019/0.004) and FACT-Ntx questionnaire item nine, “I have trouble feeling the shape of small objects when they are in my hand” (median mTEC change of 0.14; p=0.049). Conclusions: PV may be potentially useful as an objective method to evaluate CIPN, in particular sensory dominant CIPN, but further study is necessary. Clinical trial information: 000005294.