BRACHY: A Randomized Trial to Evaluate Symptom Improvement in Advanced Non-Small Cell Lung Cancer Treated With External Beam Radiation With or Without High-Dose-Rate Intraluminal Brachytherapy

Autor: Ranjan Sur, Gregory Pond, Conrad Falkson, Ming Pan, James Wright, Andrea Bezjak, Anne Dagnault, Edward Yu, Maha Almahmudi, Serge Puksa, Darin Gopaul, Theos Tsakiridis, Anand Swaminath, Peter Ellis, Timothy Whelan
Rok vydání: 2023
Předmět:
Zdroj: International Journal of Radiation Oncology*Biology*Physics.
ISSN: 0360-3016
DOI: 10.1016/j.ijrobp.2022.12.049
Popis: Uncontrolled studies suggest that the addition of high dose rate intraluminal brachytherapy (HDRIB) to external beam radiotherapy (EBR) may improve palliation for patients with advanced non-small cell lung cancer (NSCLC). The purpose of this study was to evaluate the potential clinical benefit of adding HDRIB to EBR in a multicenter randomized trial.Patients with symptomatic stage III or IV NSCLC with endobronchial disease were randomized to EBR (20Gy in 5 daily fractions or 30Gy in 10 daily fractions) or the same EBR+HDRIB (14Gy in 2 fractions over two weeks). The primary outcome was the proportion of patients who achieved symptomatic improvement in patient-reported overall lung cancer symptoms on the Lung Cancer Symptom Scale (LCSS) at 6 weeks following randomization. Secondary outcomes included improvement in individual symptoms, symptom progression free survival, overall survival and toxicity. The planned sample size was 250 patients based on detection of symptomatic improvement from 40 to 60% with a two-sided α of 0.05 and 80% power.134 patients were randomized over 4.5 years: 67 to each arm. The study closed early due to slow accrual. The mean age was 69.8 years, and 67% had metastatic disease. At six weeks 19 patients (28.4%) in the EBR arm and 20 patients (29.9%) in the EBR+HDRIB arm experienced an improvement in lung cancer symptoms (p=0.84). When limited to patients who completed the LCSS percentages were 40.4% vs 47.6%, respectively, p=0.49. Between group differences in mean change scores (0.3-0.5 standard deviations) in favor of EBR+HDRIB were observed for overall symptoms, but only hemoptysis was significantly improved (p=0.03). No significant differences were observed in progression free or overall survival. Grade 3/4 toxicity was similar between groups.Small to moderate improvements were seen in symptom relief with the combined therapy, but they did not reach statistical significance. Further research is necessary before recommending HDRIB in addition to EBR for palliation of lung cancer symptoms.
Databáze: OpenAIRE