Identifying patient characteristics associated with chemotherapy-induced peripheral neuropathy (CIPN) severity in a phase II clinical trial: A retrospective analysis.

Abstract

e24067 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of chemotherapy agents such as platinum, taxanes, vinca alkaloids, and bortezomib. Currently, as no effective prevention strategy is available, chemotherapy delay, reduction, and discontinuation are often necessary due to worsening CIPN. Our retrospective study aimed to identify patient characteristics associated with CIPN during neoadjuvant or adjuvant weekly paclitaxel chemotherapy in patients with early-stage breast cancer. Methods: We retrospectively collected baseline data from the screening phase in a phase IIA trial of weekly acupuncture intervention in women with early-stage breast cancer (ClinicalTrial.gov NCT02364726); the primary outcome was reported previously. Baseline data including age; body mass index (BMI); gender; race; CIPN severity; hemoglobin; hemoglobin A1c; TSH; vitamins B6, B12, and D levels; and anxiety and depression were retrospectively extracted from the electronic medical record (EMR) on the first day of treatment or up to four months prior to chemotherapy initiation. CIPN severity was measured by the Common Terminology Criteria for Adverse Events v4.0. Chemotherapy relative dose density (RDI) was calculated by total chemotherapy dose received divided by the total chemotherapy dose planned; disease recurrence and mortality rate were collected at the time of analysis. Logistic regression was used for statistical analysis. Results: A total of 105 patients’ baseline characteristics were extracted from the EMR. Baseline BMI was associated with CIPN severity (odds ratio [OR] 1.08; 95% confidence interval [CI] 1.01-1.16, p= 0.04). No significant correlations were observed in other covariates. At the median follow-up of 61 months, there were 12 (11.4%) breast cancer recurrences and 8 (7.6%) breast cancer-related deaths. Chemotherapy RDI was associated with disease-free survival (DFS, OR 1.026; 95% CI 1.00-1.05; p= 0.028). Conclusions: In this retrospective analysis, increased BMI was associated with worsening CIPN severity. Chemotherapy RDI was associated with improved DFS. Our findings suggest that baseline BMI may be a risk factor for CIPN. Additionally, suboptimal chemotherapy delivery due to CIPN maybe negatively impact DFS in patients with breast cancer. Further study is warranted to identify risks for CIPN.