Clinical and quality of life outcomes in the first United Kingdom randomized trial of endobronchial brachytherapy (intraluminal radiotherapy) vs. external beam radiotherapy in the palliative treatment of inoperable non-small cell lung cancer

Background and purpose: A randomized controlled trial was designed to evaluate the clinical and quality of life (QL) outcomes of patients receiving endobronchial brachytherapy (EBT) or external beam radiotherapy (XRT) as a primary palliative treatment in advanced lung cancer. Materials and methods: Ninety-nine patients presenting de novo with lung cancer were randomized to receive EBT or XRT. Eleven key symptoms or clinical signs were assessed by clinicians and patient ratings using self-assessment questionnaires were obtained at the same time. The primary endpoints were a comparison of EBT and XRT for symptom relief and acute and late side-effects (palliation) and their effect on patients' functional status and patient-rated QL outcomes. A secondary objective was a comparison of clinician assessments with patient self-reported symptoms. Results: Both treatments produced good levels of symptom relief. They were better for XRT at the expense of more acute morbidity. Late side-effects were similar. The functional status of patients was well maintained and changed similarly with time in both groups. XRT gave a better duration of palliation. Twenty-eight percent of XRT patients required EBT (at a median time of 304 days) whereas 51% of EBT patients subsequently had XRT (at a median of 125 days). There was a significant modest gain in median survival with initial XRT (287 vs. 250 days). When clinician and patient assessments were compared, doctors were found to underestimate the severity of breathlessness, anorexia, tiredness and nausea. Conclusions: Fractionated XRT is preferred to EBT as an initial treatment in better performance patients because it provides better overall and more sustained palliation with fewer retreatments and a modest gain in survival time. QL assessment is required in the evaluation of palliative treatments because clinicians frequently underestimate the incidence and severity of key symptoms. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.