Validation of the Patient Neurotoxicity Questionnaire (PNQ) During Taxane Chemotherapy in a Phase III Randomized Trial in Patients with Breast Cancer:

• Taxanes (paclitaxel, docetaxel) have become standard chemotherapies for the treatment of patients with node positive breast cancer (BC). • Chemotherapy-induced peripheral neuropathy (CIPN) is a common and serious clinical problem that occurs during taxane therapy. • CIPN can be dose-limiting and result in treatment delays, dose modifications, and in severe cases, treatment discontinuation. • The most widely used method for the assessment of CIPN is the National Cancer Institute – Common Toxicity Criteria (NCI-CTC), a physician-based instrument which is currently not validated. • Symptoms of CIPN are subjective in nature, very similar to the symptoms of pain or nausea. • Reports in the medical literature demonstrate that physician-based scales, including the NCI-CTC, under-report both the incidence and severity of CIPN. • Objective measurements (e.g., nerve conduction velocity, NCV; vibration perception threshold, VPT; electromyography, EMG) are not diagnostically reliable in the assessment of CIPN. ver. 3.3 2006/3/2 2 Objectives for Instrumen