title: A randomised comparison of radical radiotherapy with or without chemotherapy for patients with non-small lung cancer: results from the Big Lung Trial.
abstract: BACKGROUND
  A meta-analysis of trials comparing primary treatment with or without chemotherapy for patients with non-small cell lung cancer published in 1995 suggested a survival benefit for cisplatin-based chemotherapy in each of the primary treatment settings studied, but it included many small trials, and trials with differing eligibility criteria and chemotherapy regimens.
  
  
  METHODS
  The Big Lung Trial was a large pragmatic trial designed to confirm the survival benefits seen in the meta-analysis, and this paper reports the findings in the radical radiotherapy setting. The trial closed before the required sample size was achieved due to slow accrual, with a total of 288 patients randomised to receive radical radiotherapy alone (146 patients) or sequential radical radiotherapy and cisplatin-based chemotherapy (142 patients).
  
  
  RESULTS
  There was no evidence that patients allocated sequential chemotherapy and radical radiotherapy had a better survival than those allocated radical radiotherapy alone, HR 1.07 (95% CI 0.84-1.38, P=0.57), median survival 13.0 months for the sequential group and 13.2 for the radical radiotherapy alone group. In addition, exploratory analyses could not identify any subgroup that might benefit more or less from chemotherapy.
  
  
  CONCLUSIONS
  Despite not suggesting a survival benefit for the sequential addition of chemotherapy to radical radiotherapy, possibly because of the relatively small sample size and consequently wide confidence intervals, the results can still be regarded as consistent with the meta-analysis, and other similarly designed recently published large trials. Combining all these results suggests there may be a small median survival benefit with chemotherapy of between 2 and 8 weeks.
authors.affiliation: New Cross Hospital, Wolverhampton, UK. rs@ctu.mrc.ac.uk
authors.forename: David
authors.initials: D
authors.lastname: Fairlamb
authors.forename: Robert
authors.initials: R
authors.lastname: Milroy
authors.forename: Nicole
authors.initials: N
authors.lastname: Gower
authors.forename: Mahesh
authors.initials: M
authors.lastname: Parmar
authors.forename: Michael
authors.initials: M
authors.lastname: Peake
authors.forename: Robin
authors.initials: R
authors.lastname: Rudd
authors.forename: Robert
authors.initials: R
authors.lastname: Souhami
authors.forename: Stephen
authors.initials: S
authors.lastname: Spiro
authors.forename: Richard
authors.initials: R
authors.lastname: Stephens
authors.forename: David
authors.initials: D
authors.lastname: Waller
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin