A cohort study reported in JAMA Network Open by Li et al demonstrated the superiority of patient-reported outcome measures vs other methods in assessing nerve damage in patients with cancer who underwent neurotoxic chemotherapy.
“Accordingly, the adoption of chemotherapy-induced peripheral neuropathy patient-reported outcome measures is recommended in clinical practice, as well as in future clinical trial initiatives,” the investigators remarked. “The incorporation of patient perspective will enhance therapeutic decision-making and promote precision medicine approaches, leading to improved long-term neuropathy outcomes for patients with cancer.”
Study Details
Using a dual-study design, the investigators focused on 1,033 patients with cancer who received at least two doses of neurotoxic chemotherapy (ie, taxanes, platinums, vinca alkaloids, proteasome inhibitors, and thalidomide). Their median age was 61 years (range = 50–59 years), and 65.4% were female.
Patients commencing treatment were assessed prospectively at the beginning, middle, and end of their course. Those who completed treatment within the prior 5 years were assessed cross-sectionally and completed a single assessment time point. The investigators evaluated chemotherapy-induced peripheral neuropathy via the following methods:
- Patient-reported outcome measures (European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire [EORTC-CIPN20]; Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire [FACT/GOG-Ntx]; and the National Cancer Institute patient-reported outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE])
- Neurologic and neurophysiologic measures (Total Neuropathy Score and sural and tibial compound nerve amplitudes)
- Sensory measures (grating orientation, von Frey monofilament, and two-point discrimination tasks).
Three core measurement properties were evaluated: ability to accurately assess its intended concept (convergent validity), ability to discriminate between clinically distinct groups (known-groups validity), and ability to detect changes in symptom development over time (responsiveness). Both convergent and known-groups validity were assessed cross-sectionally after the completion of treatment, whereas responsiveness was evaluated prospectively during treatment. Using linear regressions, the investigators compared the neurologic, neurophysiologic, and sensory outcome measure scores between those who reported high and low levels of chemotherapy-induced peripheral neuropathy symptoms.
Assessing Neuropathy
Patient-reported outcome measures, especially the PRO-CTCAE (Spearman’s r = 0.85; P < .001) and EORTC-CIPN20 (Spearman’s r = 0.79; P < .001) systems, demonstrated the best ability to accurately assess chemotherapy-induced peripheral neuropathy (convergent validity). This method also showed the greatest effectiveness in discriminating between the severity of chemotherapy-induced peripheral neuropathy (known-groups validity) and detecting changes at its onset (responsiveness); the EORTC-CIPN20 (Cohen's d = 0.67, 95% confidence interval [CI] = 0.52–0.83), FACT/GOG-Ntx (Cohen's d = 0.65, 95% CI = 0.49–0.81), and PRO-CTCAE (Cohen's d = 0.83, 95% CI, 0.64–1.02) assessments appeared to be especially proficient.
According to the investigators, the other measures did not achieve threshold for convergent validity (α < 0.7). Neurophysiologic and sensory measures were not found to demonstrate acceptable responsiveness. Regression models revealed that neurologic, neurophysiologic, and sensory outcome measures were significantly impaired in patients who reported high vs low levels of chemotherapy-induced peripheral neuropathy symptoms.
“Patient-reported outcome measures were the only measures to satisfy all three core measurement property criteria,” the investigators concluded. “These findings suggest that adoption of patient-reported outcome measures in clinical practice can equip clinicians with valuable information in assessing chemotherapy-induced peripheral neuropathy morbidity.”
Susanna B. Park, PhD, of The University of Sydney, is the corresponding author of the JAMA Network Open article.
Disclosure: The study was funded by grants from the Cancer Institute New South Wales, National Health and Medical Research Council, the Sydney Cancer Partners with funding from Cancer Institute New South Wales, as well as by the Clive and Vera Ramaciotti Foundation. For full disclosures of the study authors, visit jamanetwork.com.
