Abstract
BackgroundCetuximab is a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR). Skin reactions are the most common side effects of cetuximab. Rhagades of the tips of the fingers and toes, the heels and especially the interphalangeal joints are one of the most frightening and painful dermatological side effects that may develop from EGFR-inhibitor therapy. Rhagades are characterized by pain, severe tenderness and poor healing response. They are challenging to treat. Thus, rhagades often poses the most significant threat to the quality of life (QoL) for these patients. Ethyl-2-cyanoacrylate (ECA), an ethyl ester of the 2-cyano-2-propenoic acid, is often used as adhesive in a variety of different work settings in industry, i.e. as a component in nail-care products such as nail glue. In addition, ECA is used for various medical indications, such as for liquid bandages and for suture-less surgery. Wound healing can be accelerated with ECA. The purpose of the SUPPORT trial is to investigate the efficacy of ECA for the treatment of cetuximab-induced rhagades and to assess the clinical usefulness of the SUPO score, a new classification system for rhagades induced by EGFR-inhibitor therapy.Methods/DesignThe SUPPORT trial is an open-label, prospective, randomized, national multicenter intervention study to evaluate the effectiveness of ECA versus the standard treatment of each institution on the pain intensity and QoL in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy. Primary endpoint is the assessment of the pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS). Secondary endpoints are the evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI).DiscussionDuring treatment with EGFR inhibitors it is necessary to recognize and manage side effects promptly to assure better patient QoL. The SUPPORT trial is the first randomized clinical trial evaluating a new treatment option for painful cetuximab-induced rhagades. Furthermore, the new SUPO score will be prospectively assessed in terms of clinical usefulness for classification of EGFR inhibitor-induced rhagades.Trial registrationCurrent Controlled Trials NCT01693159.
Highlights
Cetuximab is a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR)
The new SUPO score will be prospectively assessed in terms of clinical usefulness for classification of EGFR inhibitor-induced rhagades
Focus of the analysis is to evaluate a superiority of ECA compared to any standard treatment used in the participating institutions concerning pain relieve and improvement of quality of life (QoL)
Summary
Cetuximab is a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR). Rhagades occur in about 15% to 25% of all patients treated with an EGFR-inhibitor and are characterized by pain, severe tenderness and poor healing tendency. They can be very painful and, may create a risk for local or systemic infection [16,17]. All of those dermatological toxicities including cetuximab-induced rhagades have often led to reduction or even cessation of an effective anticancer therapy and they have been shown to decrease patients' quality of life (QoL) significantly. An appropriate scoring system is warranted to classify the EGFR inhibitor induced rhagades and to allow rational treatment decisions based on a standardized clinical scoring system
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