Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02
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The aim of the study was to determine the feasibility and validity of a newly developed patient-based instrument—the Patient Neurotoxicity Questionnaire (PNQ)—for grading chemotherapy-induced peripheral neuropathy (CIPN).
Patients and methods
We prospectively collected data from 300 female patients who were treated with taxane chemotherapy for primary breast cancer as part of a national multicenter phase III randomized trial (N-SAS BC 02). We evaluated patient compliance with the PNQ and several validation parameters, including concordance between CIPN grades noted by physicians (National Cancer Institute Common Toxicity Criteria) and patients (PNQ), and the concurrent validity and responsiveness of the PNQ versus the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) utilizing data at pre-treatment and before three, five, and seven treatment cycles.
The questionnaire completion rate was >90% at all assessments. Evaluation by physicians always resulted in lower neuropathy assessment scores compared with those reported directly by patients (weighted kappa coefficients, 0.02–0.06). Both PNQ sensory and motor scores were significantly correlated with the FACT/GOG-Ntx (r = 0.66 and 0.51, respectively). In the repeated measures analysis of variance model, PNQ grades increased considerably as treatment continued, indicating progressively worsening CIPN over time.
The PNQ has an applicable degree of feasibility and validity, useful for the diagnosis of CIPN as well as for clinical treatment decision-making, where the development of CIPN is a potential treatment-limiting consideration. Physicians underreport and underestimate the severity of CIPN symptoms compared with patients, thereby supporting the importance of assessing patient-reported outcomes using the PNQ.
KeywordsNeurotoxicity Patient Neurotoxicity Questionnaire (PNQ) Validation Patient-reported outcomes Peripheral neuropathy
We are grateful to all the patients who participated in this study and all investigators who enrolled patients into the trial. We also thank Yumiko Nomura for data management support and Michiko Kato for assistance with editing the manuscript. This study was mainly supported by the Comprehensive Support Project for Oncology Research (CSPOR) and the Comprehensive Support Project for Health Outcomes Research (CSP-HOR) established by the Public Health Research Foundation (PHRF) in Tokyo, Japan.
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