title: 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.
abstract: OBJECTIVE
  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).
  
  
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, 1-1-1 Noji Higashi, Kusatsu, Shiga, 525-8577, Japan. k-shimoz@sk.ritsumei.ac.jp
authors.forename: Kojiro
authors.initials: K
authors.lastname: Shimozuma
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Ayano
authors.initials: A
authors.lastname: Takeuchi
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Aranishi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Kuroi
authors.forename: Shozo
authors.initials: S
authors.lastname: Ohsumi
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Makino
authors.forename: Hirohumi
authors.initials: H
authors.lastname: Mukai
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Katsumata
authors.forename: Yoshihide
authors.initials: Y
authors.lastname: Sunada
authors.forename: Toru
authors.initials: T
authors.lastname: Watanabe
authors.forename: Frederick H
authors.initials: FH
authors.lastname: Hausheer