Sensory neuropathy and neuropathic pain during taxane chemotherapy in CIPN-free patients.

Abstract

e24186 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common toxicity of taxane chemotherapy and includes both sensory neuropathy and neuropathic pain. The longitudinal course of these symptoms among patients without neuropathy at treatment initiation is not well characterized. Describing symptom trajectories during taxane therapy may inform monitoring and prevention strategies. Methods: PACT, a multinational coordinated study, pooled data from three parallel randomized trials in patients with early-stage breast cancer receiving taxane chemotherapy. Participants screened negative for neuropathy at baseline using PRO-CTCAE items. Trials compared acupuncture with an active relaxation–nature-video control. Sensory neuropathy was assessed using the EORTC CIPN-20 sensory subscale (0–100), and neuropathic pain using a 0–10 worst pain Likert scale at baseline, week 12 (primary timepoint), and week 24 (follow-up). Longitudinal mixed-effects models estimated symptom trajectories, adjusting for site, chemotherapy schedule, and number of neurotoxic agents. Pairwise time comparisons use model-adjusted estimates with Tukey–Kramer adjustment. Given no treatment differences, values are presented as averages across arms. Results: Among 127 evaluable participants, model-adjusted mean CIPN-20 sensory scores increased 7.7 points (95% adj CI: 4.8 to 10.6, adj p<0.0001) from baseline to week 12 and remained stable at 24 weeks. Worst neuropathic pain increased 0.64 points (95% adj CI: 0.18–1.09; adj p=0.004) at 12 weeks with no further significant change at 24 weeks. Median worst pain scores remained 0 at all timepoints, while sensory scores rose from 0 at baseline to 3.7 at week 12. (Table 1) Conclusions: Sensory neuropathy and worst pain scores increased during taxane chemotherapy. Sensory changes were clinically significant, while changes in pain were subclinical and the majority of patients remained free of pain at all time points. These findings highlight the heterogeneous manifestation of CIPN during standard chemotherapy in an integrative medicine primary CIPN prevention trial and underscore the importance of carefully assessing both sensory and pain-related outcomes in prevention strategies. Clinical trial information: NCT05528263, ChiCTR2200066714, KCT0008470 . Model-adjusted symptom trajectories. Mean Change (95% adj CI; adj p-value) Outcome Baseline Week 12 Week 24 Week 12 - Baseline Week 24 – Week 12 Week 24 - Baseline CIPN-20 sensory(0–100) 0.6 8.3 8.5 7.7 (4.8 to 10.6; <0.0001) 0.2 (-2.8 to 3.1; 0.99) 7.8 (4.7 to 10.9; <0.0001) Worst neuropathic pain(0–10) 0.33 0.97 1.19 0.64 (0.18 to 1.09; 0.004) 0.22 (-0.16 to 0.60; 0.35) 0.86 (0.35 to 1.36; 0.0003) Predicted means and pairwise changes averaged across arms; CI and p-values adjusted for multiple comparisons (Tukey–Kramer).