The International Atomic Energy Agency (IAEA) randomized trial of palliative treatment of incurable locally advanced non small cell lung cancer (NSCLC) using radiotherapy (RT) and chemotherapy (CHT) in limited resource setting

Abstract 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 39 Gy in 13 fractions as RT alone (arm A, n = 31) or 2-3 platinum-based CHT cycles followed by 10 Gy in a single fraction or 16 Gy 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 8 months, while median survival was 7.1 and 8.1 months 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.