The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: The QLQ-CIPN20

Abstract

Chemotherapy-induced peripheral neuropathy (CIPN) is a common phenomenon, often resulting in serious limitations in daily functioning and comprosised quality of life. Currently available toxicity grading systems typically use a combination of clinical and paraclinical parameters and relies on the judgment of clinicians and/or nurses. However, because many of the symptoms of CIPN are subjective in nature, it is only logical that an assessment of CIPN be based, at least in part, on patient self-report data. We report on the development of a patient self-report questionnaire, the CIPN20, intended to supplement the core quality of life questionnaire of the European Organization for Research and Treatment of Cancer (EORTC). Following EORTC guidelines, relevant CIPN-related issues were identified from a literature survey and interviews with health professionals (n = 15) and patients (n = 112). The resulting 20-item questionnaire was pre-tested in three languages and four countries and is currently being examined in a large, international clinical trial. The EORTC CIPN20 should provide valuable information on CIPN-related symptoms and functional limitations of patients exposed to potentially neurotoxic chemotherapeutic and/or neuroprotective agents.

Introduction

Peripheral neuropathy can be defined as a derangement in structure and function of peripheral motor, sensory and autonomic neurons causing peripheral neuropathic signs and symptoms. Chemotherapy-induced peripheral neuropathy (CIPN) is a major, potentially dose-limiting side effect of several chemotherapeutic agents including platinum analogs, vinca alkaloids and taxanes. The incidence of CIPN may be as high as 100% in treated patients, depending on dose and dose-intensity of the chemotherapy regime. The neurotoxic side effects may be very long lasting and its treatment is usually difficult. Neuroprotective agents are currently being investigated to prevent or ameliorate CIPN.

Chemotherapy-induced peripheral neuropathy may seriously compromise patients’ quality of life (QL) [1], [2]. Therefore, it is important to be able to assess CIPN in a valid and reliable manner, both in clinical trials of new chemotherapeutic agents and in clinical practice, where the treatment is known or suspected to induce CIPN [3]. The two most widely used cancer-specific QL questionnaires are the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the Functional Assessment of Cancer Therapy (FACT-G) [4], [5]. Both of these questionnaires are designed to assess a core set of QL issues and are intended to be supplemented by additional condition- or treatment-specific modules or subscales. Recently, a paclitaxel-induced peripheral neurotoxicity module was added to the FACT measurement system, comprising eleven neurotoxicity and five paclitaxel-related items [6], [7]. The EORTC measurement system does not yet have a CIPN module, although several of the existing EORTC questionnaires include a few items pertaining to CIPN (e.g., pain, paresthesias). The primary objective of the current project was to develop a questionnaire module on CIPN to supplement the EORTC QLQ-C30.