Thorax 59:828-836 doi:10.1136/thx.2003.020164
  • Lung cancer

Chemotherapy versus supportive care in advanced non-small cell lung cancer: improved survival without detriment to quality of life

  1. S G Spiro1,
  2. R M Rudd2,
  3. R L Souhami3,
  4. J Brown4,
  5. D J Fairlamb5,
  6. N H Gower6,
  7. L Maslove7,
  8. R Milroy8,
  9. V Napp4,
  10. M K B Parmar9,
  11. M D Peake10,
  12. R J Stephens9,
  13. H Thorpe4,
  14. D A Waller10,
  15. P West7,
  16. on behalf of all the Big Lung Trial participants
  1. 1University College London Hospitals, London, UK
  2. 2St Bartholomew’s Hospital, London, UK
  3. 3Cancer Research UK
  4. 4Clinical Trials and Research Unit at the University of Leeds, Leeds, UK
  5. 5New Cross Hospital, Wolverhampton, UK
  6. 6Cancer Research UK and UCL Cancer Trials Centre, London, UK
  7. 7York Health Economics Consortium Ltd, University of York, York, UK
  8. 8North Glasgow University Hospitals NHS Trust, Glasgow, UK
  9. 9MRC Clinical Trials Unit, London, UK
  10. 10Glenfield Hospital, Leicester, UK
  1. Correspondence to:
    MrR J Stephens
    MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK;
  • Received 16 December 2003
  • Accepted 1 July 2004


Background: In 1995 a meta-analysis of randomised trials investigating the value of adding chemotherapy to primary treatment for non-small cell lung cancer (NSCLC) suggested a small survival benefit for cisplatin-based chemotherapy in each of the primary treatment settings. However, the meta-analysis included many small trials and trials with differing eligibility criteria and chemotherapy regimens.

Methods: The aim of the Big Lung Trial was to confirm the survival benefits seen in the meta-analysis and to assess quality of life and cost in the supportive care setting. A total of 725 patients were randomised to receive supportive care alone (n = 361) or supportive care plus cisplatin-based chemotherapy (n = 364).

Results: 65% of patients allocated chemotherapy (C) received all three cycles of treatment and a further 27% received one or two cycles. 74% of patients allocated no chemotherapy (NoC) received thoracic radiotherapy compared with 47% of the C group. Patients allocated C had a significantly better survival than those allocated NoC: HR 0.77 (95% CI 0.66 to 0.89, p = 0.0006), median survival 8.0 months for the C group v 5.7 months for the NoC group, a difference of 9 weeks. There were 19 (5%) treatment related deaths in the C group. There was no evidence that any subgroup benefited more or less from chemotherapy. No significant differences were observed between the two groups in terms of the pre-defined primary and secondary quality of life end points, although large negative effects of chemotherapy were ruled out. The regimens used proved to be cost effective, the extra cost of chemotherapy being offset by longer survival.

Conclusions: The survival benefit seen in this trial was entirely consistent with the NSCLC meta-analysis and subsequent similarly designed large trials. The information on quality of life and cost should enable patients and their clinicians to make more informed treatment choices.