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-smallcell lung cancer

Background and purpose: A randomized controlled trial was designed to evalu ate the clinical and quality of life (QL) outcomes of patients receiving en dobronchial brachytherapy (EBT) or external beam radiotherapy (XRT) as a pr imary palliative treatment in advanced lung cancer. Materials and methods: Ninety-nine patients presenting de novo with lung ca ncer were randomized to receive EBT or XRT. Eleven key symptoms or clinical signs were assessed by clinicians and patient ratings using self-assessmen t 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-eff ects (palliation) and their effect on patients' functional status and patie nt-rated QL outcomes. A secondary objective was a comparison of clinician a ssessments 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 we re similar. The functional status of patients was well maintained and chang ed similarly with time in both groups. XRT gave a better duration of pallia tion. Twenty-eight percent of XRT patients required EBT (at a median time o f 304 days) whereas 51% of EBT patients subsequently had XRT (at a median o f 125 days). There was a significant modest gain in median survival with in itial XRT (287 vs. 250 days). When clinician and patient assessments were c ompared, doctors were found to underestimate the severity of breathlessness , anorexia, tiredness and nausea. Conclusions: Fractionated XRT is preferred to EBT as an initial treatment i n better performance patients because it provides better overall and more s ustained palliation with fewer retreatments and a modest gain in survival t ime. QL assessment is required in the evaluation of palliative treatments b ecause clinicians frequently underestimate the incidence and severity of ke y symptoms. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.