N S Russell1, E van Werkhoven2, S B Schagen3. 1. Department of Radiotherapy, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. n.russell@nki.nl. 2. Department of Biometrics, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. 3. Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Abstract
PURPOSE: Skin toxicity is a common effect from radiotherapy, although difficult to predict on an individual basis, and there is little evidence-based management. This study aimed to quantify inter-patient variation in patient-reported outcome measures for radiation-induced skin reactions (RISR) to enable the determination of the number of patients required for adequate power in a comparative trial of RISR management strategies. METHODS: The study included 154 patients scheduled to receive breast cancer radiotherapy. Patients filled in a weekly questionnaire during and up to 4 weeks following the end of radiotherapy scoring five aspects of their experience of RISR: skin redness, and bother from redness like itching, burning sensation and tenderness/pain. RESULTS: Assessment of patients' reported experience of their RISR was shown to be feasible, with 91 % of patients returning at least two questionnaires. The mean score increase between weeks 1 and 4 was 25 points (p value <0.0001, 95 % CI 21-29), and the estimated standard deviation at 4 weeks was 18 (95 % CI 16-21). CONCLUSIONS: Patients' assessment of their reaction was not predicted on the basis of treatment and patient-related characteristics. Based on the observed variance in scores at 4 weeks, we could calculate the sample size required for a comparative study of two RISR management policies would be 200 patients to have statistical power to detect a clinically significant difference in patient-rated scores of their skin reactions. A trial employing this tool would help provide an evidence base to guide policy in advising patients how to manage their RISR.
PURPOSE:Skin toxicity is a common effect from radiotherapy, although difficult to predict on an individual basis, and there is little evidence-based management. This study aimed to quantify inter-patient variation in patient-reported outcome measures for radiation-induced skin reactions (RISR) to enable the determination of the number of patients required for adequate power in a comparative trial of RISR management strategies. METHODS: The study included 154 patients scheduled to receive breast cancer radiotherapy. Patients filled in a weekly questionnaire during and up to 4 weeks following the end of radiotherapy scoring five aspects of their experience of RISR: skin redness, and bother from redness like itching, burning sensation and tenderness/pain. RESULTS: Assessment of patients' reported experience of their RISR was shown to be feasible, with 91 % of patients returning at least two questionnaires. The mean score increase between weeks 1 and 4 was 25 points (p value <0.0001, 95 % CI 21-29), and the estimated standard deviation at 4 weeks was 18 (95 % CI 16-21). CONCLUSIONS:Patients' assessment of their reaction was not predicted on the basis of treatment and patient-related characteristics. Based on the observed variance in scores at 4 weeks, we could calculate the sample size required for a comparative study of two RISR management policies would be 200 patients to have statistical power to detect a clinically significant difference in patient-rated scores of their skin reactions. A trial employing this tool would help provide an evidence base to guide policy in advising patients how to manage their RISR.
Authors: Ingela Turesson; Jan Nyman; Fredrik Qvarnström; Martin Simonsson; Majlis Book; Ingegerd Hermansson; Sunna Sigurdardottir; Karl-Axel Johansson Journal: Radiother Oncol Date: 2009-11-20 Impact factor: 6.280
Authors: Raymond Javan Chan; Joan Webster; Bryan Chung; Louise Marquart; Muhtashimuddin Ahmed; Stuart Garantziotis Journal: BMC Cancer Date: 2014-01-31 Impact factor: 4.430
Authors: Gabriela Näf; Urs E Gasser; Hans E Holzgang; Sandra Schafroth; Christoph Oehler; Daniel R Zwahlen Journal: Int J Breast Cancer Date: 2018-07-02