Patient-reported short-term and long-term physical and psychologic symptoms: Results of the continuous hyperfractionated accelerated radiotherapy (CHART) randomized trial in non-small-cell lung cancer

Purpose: The randomized multicenter trial of continuous hyperfractionated accelerated radiotherapy (CHART) versus conventional radiotherapy for patients with nonsmall-cell lung cancer (NSCLC) showed a significant survival benefit to CHART (29% v 20% at 2 years, P = .004). However, an assessment of the effect on physical and psychologic symptoms is vital to balance the costs and benefits of the two treatments. Methods: A total of 356 patients in the United Kingdom completed the Rotterdam Symptom Checklist (RSCL) and the Hospital Anxiety and Depression Scale (HADS) at 10 time points. The principal aim of the analyses was to keep the methods simple, so as to allow the presentation and interpretation of the results to be as clear as possible. This was achieved by (1) considering individual symptoms rather than symptom subscales or domains, (2) assessing short-term effects (up to 3 months) and long-term effects (at 1 and 2 years) separately, and (3) for the short-term analyses, (a) splitting the data randomly into an exploratory data set and a confirmatory data set, and (b) using two different methods of analysis: a subject specific approach, which used the area under the curve (AUC) as a summary measure, and ct group-based method, which plotted the percent of patients with moderate or severe symptoms over time. Results: The results indicate that apart from CHART causing transient pain on swallowing and heartburn, there was little difference between the regimens in the short or long-term. Conclusion: Combining the results of the patient assessed symptom comparisons with the clinical results indicates that CHART confers a major benefit without serious morbidity. J Clin Oncol 16:3082-3093. (C) 1998 by American Society of Clinical Oncology.