1590P - Prospective Validation of Patient Neurotoxicity Questionnaire (PNQ) for Assessment of Oxaliplatin Neurotoxicty: CSP-HOR 16

Abstract

ABSTRACT Background Oxaliplatin-containing regimens are the standard of care for colorectal cancers. Quality of life is impaired in patients with oxaliplatin neurotoxicity. Patient-reported outcomes are important for evaluating adverse effects that are difficult for physicians to assess objectively. We prospectively investigated the feasibility and validity of a patient-based scale, the Patient Neurotoxicity Questionnaire-Oxaliplatin (PNQ), for cumulative neurotoxicity of oxaliplatin. Methods We enrolled 121 oxaliplatin-naive patients treated with FOLFOX4 or modified FOLFOX6 for colorectal cancer. Neurotoxicity was evaluated with PNQ, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and Functional Assessment of Cancer Therapy / Gynecologic Oncology Group-Neurotoxicity questionnaire (FACT/GOG-Ntx). Assessments were conducted at baseline, after q 2 treatment cycles and q 8 weeks after completion of chemotherapy. We evaluated compliance, correlation and concordance between PNQ, CTCAE and FACT/GOG Ntx-subscale, and test-retest reproducibility. The probability of experiencing neurotoxicity with cumulative oxaliplatin exposure was estimated by the Kaplan-Meier method. Results One hundred thirteen patients were evaluable. The median cumulative dose of oxaliplatin was 688.4 mg/m2 (range 83.4-1655.0). Questionnaire completion rate was > 90% for all assessments during treatment. CTCAE consistently resulted in lower sensitivity and correlation compared to PNQ (weighted kappa coefficients of sensory and motor components were 0.50 and 0.38). Sensory and motor component grades of PNQ were significantly correlated with the FACT/GOG Ntx-subscale (r = 0.63 and 0.45). The test-retest reliability of PNQ sensory and motor components demonstrated Spearman correlation coefficients of 0.81 and 0.59. PNQ sensory grades increased similarly with CTCAE. PNQ motor grades were worse compared to CTCAE. Conclusions The PNQ has adequate feasibility and validity to prospectively assess oxaliplatin neurotoxicity. The PNQ is a convenient, accurate and reliable assessment tool for oxaliplatin neurotoxicity. Disclosure All authors have declared no conflicts of interest.