Logo of thoraxThoraxVisit this articleSubmit a manuscriptReceive email alertsContact usBMJ
Thorax. 2004 Oct; 59(10): 828–836.
PMCID: PMC1746842

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


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.

Full Text

The Full Text of this article is available as a PDF (146K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365–376. [PubMed]
  • Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635–642. [PubMed]
  • Fayers PM, Bleehen NM, Girling DJ, Stephens RJ. Assessment of quality of life in small-cell lung cancer using a Daily Diary Card developed by the Medical Research Council Lung Cancer Working Party. Br J Cancer. 1991 Aug;64(2):299–306. [PMC free article] [PubMed]
  • King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996 Dec;5(6):555–567. [PubMed]
  • Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139–144. [PubMed]
  • Mahmud Salaheddin M, Reilly Marie, Comber Harry. Patterns of initial management of lung cancer in the Republic of Ireland: a population-based observational study. Lung Cancer. 2003 Jul;41(1):57–64. [PubMed]
  • Cullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, et al. Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol. 1999 Oct;17(10):3188–3194. [PubMed]
  • Thongprasert S, Sanguanmitra P, Juthapan W, Clinch J. Relationship between quality of life and clinical outcomes in advanced non-small cell lung cancer: best supportive care (BSC) versus BSC plus chemotherapy. Lung Cancer. 1999 Apr;24(1):17–24. [PubMed]
  • Helsing M, Bergman B, Thaning L, Hero U. Quality of life and survival in patients with advanced non-small cell lung cancer receiving supportive care plus chemotherapy with carboplatin and etoposide or supportive care only. A multicentre randomised phase III trial. Joint Lung Cancer Study Group. Eur J Cancer. 1998 Jun;34(7):1036–1044. [PubMed]
  • Anelli A, Lima CA, Younes RN, Gross JL, Fogarolli R. Chemotherapy versus best supportive care in stage IV non-small cell lung cancer, non metastatic to the brain. Rev Hosp Clin Fac Med Sao Paulo. 2001 Mar-Apr;56(2):53–58. [PubMed]
  • Jaakkimainen L, Goodwin PJ, Pater J, Warde P, Murray N, Rapp E. Counting the costs of chemotherapy in a National Cancer Institute of Canada randomized trial in nonsmall-cell lung cancer. J Clin Oncol. 1990 Aug;8(8):1301–1309. [PubMed]
  • Evans WK, Le Chevalier T. The cost-effectiveness of navelbine alone or in combination with cisplatin in comparison to other chemotherapy regimens and best supportive care in stage IV non-small cell lung cancer. Eur J Cancer. 1996 Dec;32A(13):2249–2255. [PubMed]
  • Billingham LJ, Bathers S, Burton A, Bryan S, Cullen MH. Patterns, costs and cost-effectiveness of care in a trial of chemotherapy for advanced non-small cell lung cancer. Lung Cancer. 2002 Aug;37(2):219–225. [PubMed]
  • Soria JC, Brisgand D, Le Chevalier T. Do all patients with advanced non-small-cell lung cancer benefit from cisplatin-based combination therapy? Ann Oncol. 2001 Dec;12(12):1667–1670. [PubMed]
  • Billingham LJ, Cullen MH. The benefits of chemotherapy in patient subgroups with unresectable non-small-cell lung cancer. Ann Oncol. 2001 Dec;12(12):1671–1675. [PubMed]
  • Schiller Joan H, Harrington David, Belani Chandra P, Langer Corey, Sandler Alan, Krook James, Zhu Junming, Johnson David H. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92–98. [PubMed]
  • Sweeney CJ, Zhu J, Sandler AB, Schiller J, Belani CP, Langer C, Krook J, Harrington D, Johnson DH. Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594: a Phase II trial in patients with metastatic nonsmall cell lung carcinoma . Cancer. 2001 Nov 15;92(10):2639–2647. [PubMed]
  • Stephens RJ, Girling DJ, Machin D. Treatment-related deaths in small cell lung cancer trials: can patients at risk be identified? Medical Research Council Lung Cancer Working Party. Lung Cancer. 1994 Sep;11(3-4):259–274. [PubMed]
  • Spiro SG, Gower NH, Evans MT, Facchini FM, Rudd RM. Recruitment of patients with lung cancer into a randomised clinical trial: experience at two centres. On behalf of the Big Lung Trial Steering Committee. Thorax. 2000 Jun;55(6):463–465. [PMC free article] [PubMed]
  • Silvestri G, Pritchard R, Welch HG. Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. BMJ. 1998 Sep 19;317(7161):771–775. [PMC free article] [PubMed]
  • Brundage MD, Feldman-Stewart D, Cosby R, Gregg R, Dixon P, Youssef Y, Mackillop WJ. Cancer patients' attitudes toward treatment options for advanced non-small cell lung cancer: implications for patient education and decision support. Patient Educ Couns. 2001 Nov;45(2):149–157. [PubMed]

Articles from Thorax are provided here courtesy of BMJ Group


Save items

Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...


  • Cited in Books
    Cited in Books
    PubMed Central articles cited in books
  • MedGen
    Related information in MedGen
  • PubMed
    PubMed citations for these articles

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...