Measurement properties of brief neuropathy screening items in cancer patients receiving taxanes, platinums, or proteasome inhibitors.

BACKGROUND

Timely detection of chemotherapy-induced peripheral neuropathy (CIPN) is critical to effectively tailor chemotherapy dose levels and offer supportive care. The purpose of this secondary analysis was to determine the reliability and validity of the two Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) numbness and tingling severity and interference items to screen for CIPN in patients receiving taxanes, platinums, or proteasome inhibitors.

METHODS

Participants (N = 142) completed the two PRO-CTCAE items, a 0-10 numerical rating scale of worst CIPN pain intensity, and the Quality of Life Questionnaire-CIPN20 (QLQ-CIPN20) prior to three clinical visits (T1, T2, T3) during neurotoxic chemotherapy. Participants completed the two PRO-CTCAE items again following the T3 clinical visit (T4). In addition, study staff administered the modified Total Neuropathy Score-Clinical Version (TNSc©) at T3. We examined floor (i.e., no CIPN severity or interference) and ceiling effects, test-retest reliability, concurrent validity, longitudinal validity, construct validity of the response categories, and sensitivity and specificity of the two PRO-CTCAE items.

RESULTS

At T3, 29% of participants had PRO-CTCAE severity scores at the floor; 60.1% of participants reported interference item scores at the floor. Agreements between scores reported at T3 and T4 for PRO-CTCAE severity (ICC = 0.79) and interference (ICC = 0.73) were moderate to strong. The PRO-CTCAE severity and interference items correlated moderately-strongly with QLQ-CIPN20 sensory (Spearman's ρ-range = 0.53-0.72) and motor (Spearman's ρ-range = 0.50-0.58) subscale scores. The Cohen's d from T1 to T3 for the PRO-CTCAE items were small (severity: d = 0.32, interference: d = 0.40) and comparable to the effect sizes for change observed with the QLQ-CIPN20. The PRO-CTCAE severity (0-3) and interference (0-2) response categories distinguished respondents with significantly different levels of QLQ-CIPN20 sensory and motor subscale scores (p < 0.001 via Jonckheere-Terpstra tests). The sensitivity and specificity of the PRO-CTCAE severity item (cutoff > 0) to detect probable sensory peripheral neuropathy were 95.83% and 65.22%, while the sensitivity and specificity of the PRO-CTCAE™ interference item (cutoff > 0) were 51.39% and 73.91%.

CONCLUSION

Preliminary evidence supports the reliability and validity of the PRO-CTCAE numbness and tingling items for CIPN screening, although there may be floor effects and limitations in the capacity of the PRO-CTCAE items to identify the full range of CIPN sensory and motor features beyond numbness and tingling. Trial Registration ClinicalTrials.Gov, NCT03514680. Registered 21 April 2018. https://clinicaltrials.gov/ct2/show/NCT03514680.