Quality of life in advanced non-small-cell lung cancer: Results of a Southwest Oncology Group randomized trial

C. M. Moinpour, B. Lyons, P. K. Grevstad, L. C. Lovato, J. Crowley, K. Czaplicki, Z. M. Buckner, P. A. Ganz, Karen Kelly, David R Gandara

Research output: Contribution to journalArticle

48 Scopus citations

Abstract

Purpose: The main purpose of this paper is to present the results of a randomized trial comparing the effects of two chemotherapy regimens on the Quality of life (QOL) of patients with advanced non-small-cell lung cancer (NSCLC). Trials in advanced stage disease represent an important treatment context for QOL assessment. A second purpose of this paper is to examine methods for handling the level of missing data commonly observed in the advanced stage disease context. Methods: Patients were randomized to receive cisplatin plus vinorelbine or carboplatin plus paclitaxel. The QOL of 222 patients was assessed with the Functional Assessment of Cancer Therapy - Lung (FACT-L) prior to randomization; follow-up assessments occurred at 13 and 25 weeks. Three methods were used to analyze the QOL data: (1) cross-sectional analysis of four patient categories (improved, stable, missing, and declined) based on changes in the FACT-L score, (2) a mixed linear model, and (3) a pattern mixture model. The longitudinal analyses addressed two potential data biases. Results: Questionnaire submission rates were 91% at baseline, 68% at 13 weeks, and 47% at 25 weeks. The cross-sectional and mixed linear model analyses did not show significant differences by treatment arm in patient-reported QOL. The pattern mixture model analysis, more appropriate given non-ignorable missing data, also found no statistically significant effect of treatment on patient QOL. Conclusion: We present a sensitivity analysis approach with multiple methods for analyzing treatment effects on patient QOL in the presence of substantial, non-ignorable missing data in an advanced stage disease clinical trial. We conclude that the two treatment arms did not differ statistically in their effects on patient QOL over a 25-week treatment period.

Original languageEnglish (US)
Pages (from-to)115-126
Number of pages12
JournalQuality of Life Research
Volume11
Issue number2
DOIs
StatePublished - 2002

Keywords

  • FACT-L
  • Non-small-cell lung cancer
  • Quality of life
  • Randomized trial

ASJC Scopus subject areas

  • Rehabilitation
  • Nursing(all)

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    Moinpour, C. M., Lyons, B., Grevstad, P. K., Lovato, L. C., Crowley, J., Czaplicki, K., Buckner, Z. M., Ganz, P. A., Kelly, K., & Gandara, D. R. (2002). Quality of life in advanced non-small-cell lung cancer: Results of a Southwest Oncology Group randomized trial. Quality of Life Research, 11(2), 115-126. https://doi.org/10.1023/A:1015048908822