Originally published as JCO Early Release 10.1200/JCO.2007.12.6094 on September 22 2008

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Quality-of-Life Outcomes for Adjuvant Chemotherapy in Early-Stage Non–Small-Cell Lung Cancer: Results From a Randomized Trial, JBR.10

Andrea Bezjak, Christopher W. Lee, Keyue Ding, Michael Brundage, Timothy Winton, Barbara Graham, Marlo Whitehead, David H. Johnson, Robert B. Livingston, Lesley Seymour, Frances A. Shepherd

From the National Cancer Institute of Canada Clinical Trials Group; Cancer Centre of Southeastern Ontario, Kingston; Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Ontario; University of Alberta Hospital, Edmonton, Alberta, Canada; British Columbia Cancer Agency, Fraser Valley Centre, Surrey, British Columbia; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Seattle Cancer Care Alliance, University of Washington, Seattle, WA

Corresponding author: Andrea Bezjak, MD, MSc, 610 University Ave, Room 5-810, Toronto, Ontario, M5G 2M9, Canada; e-mail: andrea.bezjak{at}rmp.uhn.on.ca

Purpose Adjuvant chemotherapy for early stage non–small-cell lung cancer (NSCLC) is now the standard of care, but there is little information regarding its impact on quality of life (QOL). We report the QOL results of JBR.10, a North American, intergroup, randomized trial of adjuvant cisplatin and vinorelbine compared with observation in patients who have completely resected, stages IB to II NSCLC.

Patients and Methods QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and a trial-specific checklist at baseline and at weeks 5 and 9 for those who received chemotherapy and at follow-up months 3, 6, 9, 12, 18, 24, 30 and 36. A 10-point change in QOL scores from baseline was considered clinically significant.

Results Four hundred eighty-two patients were randomly assigned on JBR.10. A total of 173 patients (82% of the expected) in the observation arm and 186 (85% of expected) in the chemotherapy arm completed baseline QOL assessments. The two groups were comparable, with low global QOL scores and significant symptom burden, especially pain and fatigue, after thoracotomy. Changes in QOL during chemotherapy were relatively modest; fatigue, nausea, and vomiting worsened, but there was a reduction in pain and no change in global QOL. Patients in the observation arm showed considerable improvements in QOL by 3 months. QOL, except for symptoms of sensory neuropathy and hearing loss, in those treated with chemotherapy returned to baseline by 9 months.

Conclusion The findings of this trial indicate that the negative effects of adjuvant chemotherapy on QOL appear to be temporary, and that improvements (with a return to baseline function) are likely in most patients.

published online ahead of print at www.jco.org on September 22, 2008

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00002583 [ClinicalTrials.gov]

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