title: 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
  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.
authors.affiliation: Institute of Lung Diseases, Sremska Kamenica and BioIRC Research Centre, Kragujevac, Serbia. Electronic address: nebareje@gmail.com.
authors.forename: Branislav
authors.initials: B
authors.lastname: Jeremic
authors.affiliation: International Atomic Energy Agency, Vienna, Austria.
authors.forename: Elena
authors.initials: E
authors.lastname: Fidarova
authors.affiliation: University of Witswatersrand, Johannesburg, South Africa.
authors.forename: Vinay
authors.initials: V
authors.lastname: Sharma
authors.affiliation: Nuclear Medicine, Oncology and Radiotherapy Institute, Islamabad, Pakistan.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Faheem
authors.affiliation: Misr Oncology Centre, Cairo, Egypt.
authors.forename: Aly Azmy
authors.initials: AA
authors.lastname: Ameira
authors.affiliation: Institut National de Cancer Salah Azaiz, Tunis, Tunisia.
authors.forename: Chiraz
authors.initials: C
authors.lastname: Nasr Ben Ammar
authors.affiliation: Sestre Milosrdnice Hospital, Zagreb, Croatia.
authors.forename: Ana
authors.initials: A
authors.lastname: Frobe
authors.affiliation: General Hospital, Kuala Lumpur, Malaysia.
authors.forename: FeeNee
authors.initials: F
authors.lastname: Lau
authors.affiliation: Sir Paul Boffa Hospital, La Valetta, Malta.
authors.forename: Stephen
authors.initials: S
authors.lastname: Brincat
authors.affiliation: University of Toronto, Canada.
authors.forename: Glenn
authors.initials: G
authors.lastname: Jones
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007390:International Agencies; D008175:Lung Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009678:Nuclear Energy; D010166:Palliative Care; D011446:Prospective Studies; D015996:Survival Rate
keywords: Chemotherapy; International Atomic Energy Agency; Locally advanced nonsmall cell lung cancer; Radiotherapy; Randomized trial