Originally published as JCO Early Release 10.1200/JCO.2005.09.158 on September 12 2005

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Assessment of Quality of Life in the Supportive Care Setting of the Big Lung Trial in Non–Small-Cell Lung Cancer

From the Clinical Trials Research Unit, University of Leeds; New Cross Hospital, Wolverhampton; Cancer Research United Kingdom and University College London Cancer Trials Centre; Medical Research Council Clinical Trials Unit; St Bartholomew's Hospital; The Middlesex Hospital, London; Stobhill National Health Service Trust, Glasgow; Glenfield Hospital, Leicester; and York Health Economics Consortium, University of York, United Kingdom

Address reprint requests to Julia Brown, SC, Clinical Trials Research Unit, 17 Springfield Mount, Leeds LS2 9NG, United Kingdom; e-mail: medjmb{at}leeds.ac.uk

PURPOSE: The Big Lung Trial (BLT) was a large, pragmatic trial to evaluate the addition of chemotherapy to primary treatment (ie, surgery, radical radiotherapy, or supportive care) in non–small-cell lung cancer (NSCLC). In the supportive care group, there was a small but significant survival benefit in patients treated with chemotherapy compared with supportive care alone (no chemotherapy). A substudy was undertaken to evaluate the quality of life (QoL) implications of the treatment options. QoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30) and LC17, and daily diary cards.

PATIENTS AND METHODS: EORTC QLQ-C30 and LC17 were collected at 0, 6 to 8, 12, 18, and 24 weeks. Diary cards were completed during the first 12 weeks of the study. The primary end point was global QoL at 12 weeks.

RESULTS: A total of 273 patients were randomly assigned: 138 to no chemotherapy and 135 to chemotherapy. There was no evidence of a large detrimental effect on QoL of chemotherapy. No statistically significant differences in global QoL or physical/emotional functioning, fatigue and dyspnea, and pain were detected at 12 weeks. Higher rates of palliative radiotherapy in the no chemotherapy arm may have lessened differences in QoL. Global QoL, role functioning, fatigue, appetite loss, and constipation were prognostic indicators of survival at 12 weeks.

CONCLUSION: There were no important adverse effects of chemotherapy on QoL.

Presented in part at the BCRM Clinical Trials Showcase Meeting, June 30, 2002, Glasgow; 38th Annual Meeting of the American Society of Clinical Oncology May 18-21, 2002, Orlando, FL; and BLT Participants' Meeting, April 24, 2002, Leeds, United Kingdom.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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