Skip to main content
SpringerLink
Log in

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

  • Published:
Quality of Life Research Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Moinpour CM, Feigl P, Metch B, Hayden KA, Meyskens FL Jr, Crowley J. Quality of life end points in cancer clinical trials: Review and recommendations. J Natl Cancer Inst 1989; 81: 485–495.

    Google Scholar 

  2. Nayfield SG, Ganz PA, Moinpour CM, Cella DF, Hailey BJ. Report from a National Cancer Institute (USA) workshop on quality of life assessment in cancer clinical trials. Qual Life Res 1992; 1: 203–210.

    Google Scholar 

  3. Gotay CC, Korn EL, McCabe M, Moore TD, Cheson BD. Quality of life assessment in cancer treatment protocols: Research in issues in protocol development. J Natl Cancer Inst 1992; 84: 575–579.

    Google Scholar 

  4. Aaronson NK, Ahmedzai S, Bergman B, et al. For the European Organization for Research and Treatment of Cancer Study Group on Quality of Life. The European Organization for Research and Treatment of Cancer QLQC30: A quality of life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365–376.

    Google Scholar 

  5. Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: Development and validation of the general measure. J Clin Oncol 1993; 11: 570–579.

    Google Scholar 

  6. Schag CAC, Ganz PA, Heinrich RL. Cancer rehabilitation evaluation system-Short Form (CARES-SF): A cancer specific rehabilitation and quality of life instrument. Cancer 1991; 68: 1406–1413.

    Google Scholar 

  7. Osoba D. The Quality of Life Committee of the Clinical Trials Group of the National Cancer Institute of Canada: Organization and functions. Qual Life Res 1992; 1: 211–218.

    Google Scholar 

  8. Splinter TAW. Chemotherapy in advanced non-small-cell lung cancer. Eur J Cancer 1990; 26: 1093–1099.

    Google Scholar 

  9. Bunn PA. Future directions in the management of nonsmall cell lung cancer. Lung Cancer 1993; 9: S91-S107.

    Google Scholar 

  10. Bernhard J 1991; 46: 671–675.

  11. Feld R. Quality of life in patients with non-small-cell lung cancer treated with chemotherapy. Eur J Cancer 1987; 23: 357–359.

    Google Scholar 

  12. Hollen PJ, Gralla RJ, Kris MG, Potanovich LM. Quality of Life Assessment in Individuals with Lung Cancer: Testing the Lung Cancer Symptom Scale (LCSS). Eur J Cancer 1993; 29A: S51-S58.

    Google Scholar 

  13. Kosty MP, Fleishman SB, Herndon JE, II, et al. Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-smallcell lung cancer: A randomized pacebo-controlled, doubleblind Phase III study of the cancer and leukemia Group B. J Clin Oncol 1994; 12: 1113–1120.

    Google Scholar 

  14. Crino L, Scagliotti GV, Ricci S, et al. Gemicitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: A randomized Phase III study of the Italian lung cancer project. J Clin Oncol 1999; 17: 3522–3530.

    Google Scholar 

  15. The Elderly Lung Cancer Vinorelbine Italian Study Group. Effects of Vinorelbine on Quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 1999; 91: 66–72.

    Google Scholar 

  16. Bernhard J, Cella DF, Coates AS, et al. Missing quality of life data in cancer clinical trials: Serious problems and challenges. Stat Med 1998; 17: 517–532.

    Google Scholar 

  17. Troxel AB, Fairclough DL, Curran D, Hahn EA. Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med 1998; 17: 653–666.

    Google Scholar 

  18. Fairclough DL, Peterson HF, Cella DF, Bonomi P. Comparison of several model-based methods for analysing incomplete quality of life data in cancer clinical trials. Stat Med 1998; 17: 781–796.

    Google Scholar 

  19. Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E, Bonomi P. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer 1995; 12: 199–220.

    Google Scholar 

  20. Ramsey SD, Moinpour CM, Lovato LC, et al. An economic analysis of vinorelbine/cisplatin versus paclitaxel/ carboplatin for advanced non-small-cell lung cancer. J Natl Cancer Inst 2002; 94(4): in press.

  21. Kelly K, Crowley J, Bunn PA Jr, et al. Randomized Phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: A Southwest Oncology Group trial. J Clin Oncol 2001; 19: 3210–3218.

    Google Scholar 

  22. Wozniak AJ, Crowley JJ, Balcerzak SP, et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small-cell lung cancer: A Southwest Oncology Group study. J Clin Oncol 1998; 16: 2459–2465.

    Google Scholar 

  23. Cella DF, Bonomi P. FACT Manual. Functional Assessment of Cancer Therapy (FACT) Scales and the Functional Assessment of HIV Infection (FAHI) Scale-Version 3. Chicago, IL: Rush-Presbyterean-St.Luke's Medical Center, 1994.

    Google Scholar 

  24. Cella DF. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT Scales)-Version 4. Evanston, IL: Center on Ontcomes, Research and Education, Evanston Northwestern Healthcare and Northwestern University. Center on Outcomes Research and Education (CORE), 1997.

    Google Scholar 

  25. Cronbach LJ. Coefficient a and the internal structure of tests. Psychometrika 1951; 16: 297–334.

    Google Scholar 

  26. Moinpour CM, Lovato LC. Ensuring the quality of quality of life data: The Southwest Oncology Group experience. Stat Med 1998; 17: 641–651.

    Google Scholar 

  27. Moinpour CM, Triplett JS, McKnight B, et al. Challenges posed by non-random missing quality of life data in an advanced-stage colorectal cancer clinical trial. Psycho-Oncology 2000; 9: 340–354.

    Google Scholar 

  28. Donaldson GW. Issues in quantifying and analyzing individual differences. In: Chapman CR, Foley KM (eds), Current and Emerging Issues in Cancer Pain: Research and Practice. New York, NY: Raven Press, 1993; 301–319.

    Google Scholar 

  29. Moinpour CM, Lovato LC, Thompson IM Jr, et al. Profile of men randomized to the prostate cancer prevention trial: Baseline health-related quality of life, urinary and sexual functioning, and health behaviors. J Clin Oncol 2000; 18: 1942–1953.

    Google Scholar 

  30. Hogan JW, Laird NM. Mixture models for the joint distribution of repeated measures and event times. Stat Med 1997; 16: 239–257.

    Google Scholar 

  31. Verbeke G, Molenberghs S. Linear Mixed Models in Practice. New York, NY: Springer, 1997.

    Google Scholar 

  32. SAS Institute. SAS/STAT Software: Changes and Enhancements Through Release 6.12. Cary, NC: SAS Institute, Inc., 1997.

    Google Scholar 

  33. Cox DR. Regression models and life tables (with discussion). J R Stat Soc B 1972; 34: 187–220.

    Google Scholar 

  34. Ranson M, Davidson N, Nicolson M, et al. Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 2000; 92: 1074–1080.

    Google Scholar 

  35. de Haes JC, Van Knippenberg FC, Neijt JP. Measuring psychological and physical distress in cancer patients: Structure and application of the Rotterdam Symptom Checklist. Br J Cancer 1990; 62: 1034–1038.

    Google Scholar 

  36. Hahn EA, Webster Kimberly A, Cella D, Fairclough DL. Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: Problems and solutions. Stat Med 1998; 17: 547–559.

    Google Scholar 

  37. Bonomi P, Kim K, Fairclough D, et al. Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: Results of an Eastern Cooperative Oncology Group trial. J Clin Oncol 2000; 18: 623–631.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    C.M. Moinpour, L.C. Lovato & J. Crowley

  2. Janssen Research Foundation, Titusville, NJ, USA

    B. Lyons

  3. Tumor Institute, Swedish Hospital, Seattle, WA, USA

    P.K. Grevstad

  4. Loyola University, Maywood, IL, USA

    K. Czaplicki

  5. Wichita CCOP, Wichita, KA, USA

    Z.M. Buckner

  6. University of California, Los Angeles, CA, USA

    P.A. Ganz

  7. University of Colorado Health Sciences Center, Denver, CO, USA

    K. Kelly

  8. UC Davis Cancer Center, Sacramento, CA, USA

    D.R. Gandara

Authors
  1. C.M. Moinpour
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. B. Lyons
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. P.K. Grevstad
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. L.C. Lovato
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. J. Crowley
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. K. Czaplicki
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Z.M. Buckner
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. P.A. Ganz
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. K. Kelly
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. D.R. Gandara
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Moinpour, C., Lyons, B., Grevstad, P. et al. Quality of life in advanced non-small-cell lung cancer: Results of a Southwest Oncology Group randomized trial. Qual Life Res 11, 115–126 (2002). https://doi.org/10.1023/A:1015048908822

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/A:1015048908822

Search

Navigation