Patricia Ramírez-Daffós1, Encarnación Jiménez-Orozco2, Matilde Bolaños3, Beatriz González Astorga4, Sandra Rubiales5, Eduardo Ceballos-Barbancho6, José Manuel Rodríguez García7, Juan-José Reina8. 1. Medical Oncology, University Hospital Puerta del Mar, Avenida Ana de Viya 21, 11009, Cádiz, Spain. daffos@yahoo.com. 2. Medical Oncology, Hospital Universitario de Jerez, Ctra. Trebujena S/N, 11407, Jerez de la Frontera, Spain. 3. Medical Oncology, Hospital Juan Ramón Jiménez, Ronda Norte s/n, 21005, Huelva, Spain. 4. Medical Oncology, Hospital Universitario Clínico San Cecilio, Av. del Conocimiento s/n, 18016, Granada, Spain. 5. Medical Oncology, Hospital Universitario de Puerto Real, Romería 7, 11510, Puerto Real, Spain. 6. Medical Oncology, Hospital San Pedro de Alcántara, Av. Pablo Naranjo Porras s/n, 10003, Cáceres, Spain. 7. Medical Oncology, Hospital Punta de Europa, Carretera de Getares s/n, 11207, Algeciras, Spain. 8. Medical Oncology, Hospital Universitario Virgen Macarena, Av. Dr. Fedriani 3, 41009, Seville, Spain.
Abstract
PURPOSE: To assess the efficacy, safety, and quality-of-life outcomes of doxycycline 50 or 100 mg once daily in the prevention of skin toxicity in patients undergoing chemotherapy plus anti-EGFR therapy as first-line treatment of metastatic colorectal cancer (mCRC). METHODS: Phase II, multicenter, single-arm, exploratory study was conducted in 7 Spanish hospitals. The primary study outcome was the incidence of ≥ grade 2 skin toxicities during the 6-week skin treatment period. Quality of life was assessed with the Dermatology Life Quality Index (DLQI) questionnaire. Patients had to receive either doxycycline 50 mg once daily in a first stage with 10 patients, or, if more than three patients presented ≥ grade 2 skin toxicities, the next 30 patients had to receive 100 mg once daily. RESULTS: Thirty-four patients with RAS wild-type mCRC were enrolled in the study. Ten patients were first treated with doxycycline 50 mg once daily, and the following 24 were treated with doxycycline 100 mg once daily. A total of 60.0% (95% CI 29.6-90.0) and 20.8% (95% CI 4.6-37.0) of patients who received doxycycline 50 mg/day and 100 mg/day, respectively, had at least one ≥ grade 2 skin toxicity. Patients treated with doxycycline 100 mg once daily experienced less QoL deterioration. Only 1 patient reported a mild doxycycline-related gastrointestinal adverse event. CONCLUSION: Our results suggest that doxycycline doses as low as 100 mg once daily are efficacious and well tolerated for the prevention of skin toxicity in patients with mCRC who undergo treatment with chemotherapy plus EGFR-targeted therapies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03448731.
PURPOSE: To assess the efficacy, safety, and quality-of-life outcomes of doxycycline 50 or 100 mg once daily in the prevention of skin toxicity in patients undergoing chemotherapy plus anti-EGFR therapy as first-line treatment of metastatic colorectal cancer (mCRC). METHODS: Phase II, multicenter, single-arm, exploratory study was conducted in 7 Spanish hospitals. The primary study outcome was the incidence of ≥ grade 2 skin toxicities during the 6-week skin treatment period. Quality of life was assessed with the Dermatology Life Quality Index (DLQI) questionnaire. Patients had to receive either doxycycline 50 mg once daily in a first stage with 10 patients, or, if more than three patients presented ≥ grade 2 skin toxicities, the next 30 patients had to receive 100 mg once daily. RESULTS: Thirty-four patients with RAS wild-type mCRC were enrolled in the study. Ten patients were first treated with doxycycline 50 mg once daily, and the following 24 were treated with doxycycline 100 mg once daily. A total of 60.0% (95% CI 29.6-90.0) and 20.8% (95% CI 4.6-37.0) of patients who received doxycycline 50 mg/day and 100 mg/day, respectively, had at least one ≥ grade 2 skin toxicity. Patients treated with doxycycline 100 mg once daily experienced less QoL deterioration. Only 1 patient reported a mild doxycycline-related gastrointestinal adverse event. CONCLUSION: Our results suggest that doxycycline doses as low as 100 mg once daily are efficacious and well tolerated for the prevention of skin toxicity in patients with mCRC who undergo treatment with chemotherapy plus EGFR-targeted therapies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03448731.
Authors: James Q Del Rosso; Ted Rosen; Diane Thiboutot; Guy F Webster; Richard L Gallo; James J Leyden; Clay Walker; George Zhanel; Lawrence Eichenfield Journal: J Clin Aesthet Dermatol Date: 2016-06-01