Preemptive therapy of cetuximab-induced skin rash using doxycycline, sunscreen, hydrocortisone, and moisturizer in colorectal and head and neck cancer patients.

Abstract

TPS796 Background: Toxicities associated with the use of cetuximab include infusion reactions, dermatologic toxicity and electrolyte disturbances. Of these, skin toxicity including acneiform rash, dry skin and fissuring, paronychial inflammation, infectious sequelae and hypertrichosis occur most commonly, with acneiform rash developing in 76-88% of patients. These skin toxicities are rarely life-threatening, but they impact the quality of life of patients receiving therapy and directly affect adherence. The purpose of this study is to determine if preemptive therapy with doxycycline, sunscreen, hydrocortisone 1% cream, and moisturizer will reduce the incidence and severity of > grade 2 acneiform rash according to CTCAE v.4 in patients with colorectal and head and neck cancer receiving therapy with cetuximab. Methods: This is a single-institution, prospective, open-label, randomized study of 100 patients with colorectal and head and neck cancer receiving cetuximab in the locally advanced or metastatic setting. Those randomized to preemptive therapy will receive doxycycline 100 mg twice daily, sunscreen SPF 30, hydrocortisone 1% cream, and moisturizer beginning three days prior to the first dose of cetuximab for a duration of 8 weeks. Those randomized to standard of care will receive treatment of skin toxicity per national guidelines and treating physician discretion. Objectives are to evaluate the incidence of cetuximab-induced rash, compare the severity of cetuximab-induced rash between the preemptive treatment group and the standard care group, and monitor the toxicity of the preemptive therapy. Secondary objectives include quality of life, adherence rates, disease-specific outcomes, and survival. Patients will be evaluated at enrollment, 3 weeks into treatment and at the end of treatment for adherence, side effects and quality of life. They will be followed for up to two years for treatment outcomes and survival. With alpha of 0.05 and a power of 80%, we will be able to detect if the incidence of skin rash differs by 24% between the two groups using a two-sample one-sided binomial test. As of September 2014, 15 of 100 patients have been enrolled. Clinical trial information: NCT01874860.