RESUMO
BACKGROUND: To optimize palliation in incurable locally advanced non-small cell lung cancer (NSCLC), the International Atomic Energy Agency conducted a prospective randomized study (NCT00864331) comparing protracted palliative radiotherapy (RT) course with chemotherapy (CHT) followed by short-course palliative RT. METHODS AND MATERIALS: Treatment-naive patients with histologically confirmed NSCLC, stage IIIA/IIIB, received either 39Gy in 13 fractions as RT alone (arm A, n=31) or 2-3 platinum-based CHT cycles followed by 10Gy in a single fraction or 16Gy in 2 fractions separated by one week (arm B, n=34). Primary outcome was overall survival. RESULTS: Treatment groups were balanced with respect to various variables. Median survival for all 65 patients was 8months, while median survival was 7.1 and 8.1months for the two arms, respectively (log-rank p=0.4 by study arm, and p=0.6 by Cox regression and stratified by country and sub-stage). One and three year survival rates for the two arms were 29%, and 9% and 41%, and 6%, respectively. There were no differences in any of the following endpoints: any failure, local failure, regional failure, contralateral thoracic failure, and distant failure between the two arms. High-grade (⩾3) toxicity was similar between the two arms. Symptoms, adverse events of any kind, KPS and body-mass index, were not different during treatment and during follow-up. There was no grade 5 toxicity. CONCLUSIONS: This incomplete and underpowered trial only hinted similar outcome between the treatment arms. Therefore, combined CHT-RT can perhaps be considered, in limited resource setting, where access to RT remains inadequate.