Advertisement

Quality of Life Outcomes in Radiotherapy of Lung Cancer

  • M. Salim Siddiqui
  • Farzan Siddiqui
  • Benjamin Movsas
Chapter
Part of the Medical Radiology book series (MEDRAD)

Abstract

Lung cancer is one of the most common cancers in the world. There has been an increased interest in quality of life (QOL) as a clinically meaningful endpoint in clinical trials for lung cancer. Patient-reported outcome (PRO) measurements have allowed oncologists to better understand the impact of cancer therapies on the physical, emotional and social well-being of their patients. This chapter provides a review of the clinical relevance, measurement, analysis and challenges of quality of life in lung cancer trials. A summary of salient quality-of-life studies, particularly involving radiation treatment for lung cancer, is included.

Keywords

Radiation Therapy Oncology Group Minimum Important Difference Early Palliative Care Lung Cancer Symptom Scale Subjective Significance Questionnaire 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Aaronson N, Fayers P (eds) (2002) Quality of life. Oxford textbook of oncology. Oxford University Press, OxfordGoogle Scholar
  2. Aaronson NK, Ahmedzai S et al (1993) 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 85(5):365–376PubMedCrossRefGoogle Scholar
  3. Basch E, Iasonos A et al (2006) Patient versus clinician symptom reporting using the national cancer institute common terminology criteria for adverse events: results of a questionnaire-based study. Lancet Oncol 7(11):903–909PubMedCrossRefGoogle Scholar
  4. Basch E, Jia X et al (2009) Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 101(23):1624–1632PubMedCrossRefGoogle Scholar
  5. Beller E, Tattersall M et al (1997) Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: a randomised placebo-controlled trial. Australasian megestrol acetate cooperative study group. Ann Oncol 8(3):277–283PubMedCrossRefGoogle Scholar
  6. Bergman B, Aaronson NK et al (1994) 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 30A(5):635–642PubMedCrossRefGoogle Scholar
  7. Bergner M, Bobbitt RA et al (1976) The sickness impact profile: Validation of a health status measure. Med Care 14(1):57–67PubMedCrossRefGoogle Scholar
  8. Bergner M, Bobbitt RA et al (1981) The sickness impact profile: Development and final revision of a health status measure. Med Care 19(8):787–805PubMedCrossRefGoogle Scholar
  9. Bezjak A, Dixon P et al (2002) Randomized phase III trial of single versus fractionated thoracic radiation in the palliation of patients with lung cancer (NCIC CTG SC.15). Int J Radiat Oncol Biol Phys 54(3):719–728PubMedCrossRefGoogle Scholar
  10. Blazeby JM, Brookes ST et al (2001) The prognostic value of quality-of-life scores during treatment for oesophageal cancer. Gut 49(2):227–230PubMedCrossRefGoogle Scholar
  11. Bleehen NM, Girling DJ et al (1991) Inoperable non-small-cell lung cancer (NSCLC): a medical research council randomised trial of palliative radiotherapy with two fractions or ten fractions. Report to the medical research council by its lung cancer working party. Br J Cancer 63(2):265–270CrossRefGoogle Scholar
  12. Burris HA 3rd, Moore MJ et al (1997) Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 15(6):2403–2413PubMedGoogle Scholar
  13. Cella DF, Tulsky DS (1990) Measuring quality of life today: methodological aspects. Oncology (Williston Park) 4(5):29–38 discussion 69Google Scholar
  14. Cella DF, Tulsky DS et al (1993) The functional assessment of cancer therapy scale: Development and validation of the general measure. J Clin Oncol 11(3):570–579PubMedGoogle Scholar
  15. Cella DF, Bonomi AE et al (1995) Reliability and validity of the functional assessment of cancer therapy-lung (FACT-L) quality of life instrument. Lung Cancer 12(3):199–220PubMedCrossRefGoogle Scholar
  16. Cella D, Eton DT et al (2002) What is a clinically meaningful change on the functional assessment of cancer therapy-lung (FACT-L) questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 55(3):285–295PubMedCrossRefGoogle Scholar
  17. Coates A, Porzsolt F et al (1997) Quality of life in oncology practice: Prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy. Eur J Cancer 33(7):1025–1030PubMedCrossRefGoogle Scholar
  18. Cohen J (1988) Statistical power analysis for the behavioral sciences. Erlbaum Associates, Hillsdale, N. J, LGoogle Scholar
  19. Curran D, Molenberghs G et al (1998) Incomplete quality of life data in randomized trials: Missing forms. Stat Med 17(5–7):697–709PubMedCrossRefGoogle Scholar
  20. Dancey J, Zee B et al (1997) Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The national cancer institute of canada clinical trials group. Qual Life Res 6(2):151–158PubMedCrossRefGoogle Scholar
  21. de Graeff A, de Leeuw JR et al (2001) Sociodemographic factors and quality of life as prognostic indicators in head and neck cancer. Eur J Cancer 37(3):332–339PubMedCrossRefGoogle Scholar
  22. Detmar SB, Muller MJ et al (2002) Health-related quality-of-life assessments and patient–physician communication: a randomized controlled trial. Jama 288(23):3027–3034PubMedCrossRefGoogle Scholar
  23. Efficace F, Bottomley A (2005) Toward a clearer understanding of the prognostic value of health-related quality-of-life parameters in breast cancer. J Clin Oncol 23(6):1335–1336 author reply 1336PubMedCrossRefGoogle Scholar
  24. Erridge SC, Gaze MN et al (2005) Symptom control and quality of life in people with lung cancer: a randomised trial of two palliative radiotherapy fractionation schedules. Clin Oncol (R Coll Radiol) 17(1):61–67CrossRefGoogle Scholar
  25. Fairclough DL, Peterson HF et al (1998) Comparison of several model-based methods for analysing incomplete quality of life data in cancer clinical trials. Stat Med 17(5–7):781–796PubMedCrossRefGoogle Scholar
  26. Fang FM, Liu YT et al (2004) Quality of life as a survival predictor for patients with advanced head and neck carcinoma treated with radiotherapy. Cancer 100(2):425–432PubMedCrossRefGoogle Scholar
  27. Fayers PM, Curran D et al (1998) Incomplete quality of life data in randomized trials: Missing items. Stat Med 17(5–7):679–696PubMedCrossRefGoogle Scholar
  28. Food and Drug Administration (2009) Guidance for industry: Patient-reported outcome measures: use in medical product development to support labeling claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf Google Scholar
  29. Ganz PA, Figlin RA et al (1989) Supportive care versus supportive care and combination chemotherapy in metastatic non-small cell lung cancer. Does chemotherapy make a difference?. Cancer 63(7):1271–1278PubMedCrossRefGoogle Scholar
  30. Garcia SF, Cella D et al (2007) Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol 25(32):5106–5112PubMedCrossRefGoogle Scholar
  31. Gelber RD, Gelber S (1995) Quality-of-life assessment in clinical trials. Cancer Treat Res 75:225–246PubMedCrossRefGoogle Scholar
  32. Gotay CC (2004) Assessing cancer-related quality of life across a spectrum of applications. J Natl Cancer Inst Monogr 2004(33):126–133CrossRefGoogle Scholar
  33. Guyatt GH, Osoba D et al (2002) Methods to explain the clinical significance of health status measures. Mayo Clin Proc 77(4):371–383PubMedCrossRefGoogle Scholar
  34. Hahn EA, Webster KA et al (1998) Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: Problems and solutions. Stat Med 17(5–7):547–559PubMedCrossRefGoogle Scholar
  35. Hollen PJ, Gralla RJ et al (1993) Quality of life assessment in individuals with lung cancer: Testing the lung cancer symptom scale (LCSS). Eur J Cancer 29A(Suppl 1):S51–S58PubMedCrossRefGoogle Scholar
  36. Hollen PJ, Gralla RJ et al (1994a) Quality of life during clinical trials: Conceptual model for the Lung Cancer Symptom Scale (LCSS). Support Care Cancer 2(4):213–222PubMedCrossRefGoogle Scholar
  37. Hollen PJ, Gralla RJ et al (1994b) Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies. Psychometric assessment of the lung cancer symptom scale. Cancer 73(8):2087–2098PubMedCrossRefGoogle Scholar
  38. Husted JA, Cook RJ et al (2000) Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol 53(5):459–468PubMedCrossRefGoogle Scholar
  39. Jensen K, Bonde Jensen A et al (2006) The relationship between observer-based toxicity scoring and patient assessed symptom severity after treatment for head and neck cancer. A correlative cross sectional study of the DAHANCA toxicity scoring system and the EORTC quality of life questionnaires. Radiother Oncol 78(3):298–305PubMedCrossRefGoogle Scholar
  40. Johnson JR, Temple R (1985) Food and drug administration requirements for approval of new anticancer drugs. Cancer Treat Rep 69(10):1155–1159PubMedGoogle Scholar
  41. Kaasa S, Mastekaasa A et al (1989) Prognostic factors for patients with inoperable non-small cell lung cancer, limited disease. The importance of patients’ subjective experience of disease and psychosocial well-being. Radiother Oncol 15(3):235–242PubMedCrossRefGoogle Scholar
  42. Langendijk H, Aaronson NK et al (2000a) The prognostic impact of quality of life assessed with the EORTC QLQ-C30 in inoperable non-small cell lung carcinoma treated with radiotherapy. Radiother Oncol 55(1):19–25PubMedCrossRefGoogle Scholar
  43. Langendijk JA, ten Velde GP et al (2000b) Quality of life after palliative radiotherapy in non-small cell lung cancer: a prospective study. Int J Radiat Oncol Biol Phys 47(1):149–155PubMedCrossRefGoogle Scholar
  44. Langendijk JA, Aaronson NK et al (2001) Prospective study on quality of life before and after radical radiotherapy in non-small-cell lung cancer. J Clin Oncol 19(8):2123–2133PubMedGoogle Scholar
  45. Langendijk JA, Aaronson NK et al (2002) Quality of life after curative radiotherapy in Stage I non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 53(4):847–853PubMedCrossRefGoogle Scholar
  46. Leitgeb C, Pecherstorfer M et al (1994) Quality of life in chronic anemia of cancer during treatment with recombinant human erythropoietin. Cancer 73(10):2535–2542PubMedCrossRefGoogle Scholar
  47. Leplege A, Hunt S (1997) The problem of quality of life in medicine. Jama 278(1):47–50PubMedCrossRefGoogle Scholar
  48. Little RJA, Rubin DB (2002) Statistical analysis with missing data. Hoboken, N.J, WileyGoogle Scholar
  49. Louie AV, Rodrigues G et al (2010) Stereotactic body radiotherapy versus surgery for medically operable Stage I non-small-cell lung cancer: a markov model-based decision analysis. Int J Radiat Oncol Biol Phys  doi:10.1016/j.ijrobp.2010.06.040
  50. Macbeth FR, Bolger JJ et al (1996) Randomized trial of palliative two-fraction versus more intensive 13 fraction radiotherapy for patients with inoperable non-small cell lung cancer and good performance status. Medical research council lung cancer working party. Clin Oncol (R Coll Radiol) 8(3):167–175CrossRefGoogle Scholar
  51. McHorney CA, Ware JE Jr et al (1993) The MOS 36 Item short-form health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 31(3):247–263PubMedCrossRefGoogle Scholar
  52. McHorney CA, Ware JE Jr et al (1994) The MOS 36 item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 32(1):40–66PubMedCrossRefGoogle Scholar
  53. Miller GA (1956) The magical number seven plus or minus two: Some limits on our capacity for processing information. Psychol Rev 63(2):81–97PubMedCrossRefGoogle Scholar
  54. Moinpour CM, Feigl P et al (1989) Quality of life end points in cancer clinical trials: Review and recommendations. J Natl Cancer Inst 81(7):485–495PubMedCrossRefGoogle Scholar
  55. Moinpour CM, Sawyers Triplett J et al (2000) Challenges posed by non-random missing quality of life data in an advanced-stage colorectal cancer clinical trial. Psychooncology 9(4):340–354PubMedCrossRefGoogle Scholar
  56. Montazeri A, Milroy R et al (2001) Quality of life in lung cancer patients: as an important prognostic factor. Lung Cancer 31(2–3):233–240PubMedCrossRefGoogle Scholar
  57. Movsas B (2003) Quality of life in oncology trials: a clinical guide. Semin Radiat Oncol 13(3):235–247PubMedCrossRefGoogle Scholar
  58. Movsas B, Scott C et al (2005) Randomized trial of amifostine in locally advanced non-small-cell lung cancer patients receiving chemotherapy and hyperfractionated radiation: radiation therapy oncology group trial 98–01. J Clin Oncol 23(10):2145–2154PubMedCrossRefGoogle Scholar
  59. Movsas B, Moughan J et al (2009) Quality of life supersedes the classic prognosticators for long-term survival in locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. J Clin Oncol 27(34):5816–5822PubMedCrossRefGoogle Scholar
  60. NCI, C. T. C. G. P (1988) Cancer therapy evaluation program: Guidelines. N. C. I. Division of Cancer Treatment, Bethesda, MDGoogle Scholar
  61. Nicklasson M, Bergman B (2007) Validity, reliability and clinical relevance of EORTC QLQ-C30 and LC13 in patients with chest malignancies in a palliative setting. Qual Life Res 16(6):1019–1028PubMedCrossRefGoogle Scholar
  62. Norman GR, Sloan JA et al (2003) Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 41(5):582–592PubMedGoogle Scholar
  63. Nunnaly J, Bernstein I (1994) Psychometric therapy. McGraw-Hill, Mew YorkGoogle Scholar
  64. Osoba D (1996) Rationale for the timing of health-related quality-of-life (HQL) assessments in oncological palliative therapy. Cancer Treat Rev 22(Suppl A):69–73PubMedCrossRefGoogle Scholar
  65. Osoba D, Rodrigues G et al (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16(1):139–144PubMedGoogle Scholar
  66. Pijls-Johannesma M, Houben R et al (2009) High-dose radiotherapy or concurrent chemo-radiation in lung cancer patients only induces a temporary, reversible decline in QoL. Radiother Oncol 91(3):443–448PubMedCrossRefGoogle Scholar
  67. Qian W, Parmar MK et al (2000) Analysis of messy longitudinal data from a randomized clinical trial. MRC lung cancer working party. Stat Med 19(19):2657–2674PubMedCrossRefGoogle Scholar
  68. Ribaudo HJ, Thompson SG (2002) The analysis of repeated multivariate binary quality of life data: a hierarchical model approach. Stat Methods Med Res 11(1):69–83PubMedCrossRefGoogle Scholar
  69. Rubin DB (1997) Estimating causal effects from large data sets using propensity scores. Ann Intern Med 127(8 Pt 2):757–763PubMedCrossRefGoogle Scholar
  70. Sadura A, Pater J et al (1992) Quality-of-life assessment: Patient compliance with questionnaire completion. J Natl Cancer Inst 84(13):1023–1026PubMedCrossRefGoogle Scholar
  71. Sales AE, Plomondon ME et al (2004) Assessing response bias from missing quality of life data: the Heckman method. Health Qual Life Outcomes 2:49PubMedCrossRefGoogle Scholar
  72. Sarna L, Swann S et al (2008) Clinically meaningful differences in patient-reported outcomes with amifostine in combination with chemoradiation for locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. Int J Radiat Oncol Biol Phys 72(5):1378–1384PubMedCrossRefGoogle Scholar
  73. Slevin ML, Plant H et al (1988) Who should measure quality of life, the doctor or the patient?. Br J Cancer 57(1):109–112PubMedCrossRefGoogle Scholar
  74. Sprangers MA, Sloan JA et al (2009) The establishment of the GENEQOL consortium to investigate the genetic disposition of patient-reported quality-of-life outcomes. Twin Res Hum Genet 12(3):301–311PubMedCrossRefGoogle Scholar
  75. Stewart AL, Ware JE (1992) Measuring functioning and well-being: the medical outcomes study approach. Duke University Press, DurhamGoogle Scholar
  76. Strain JJ (1990) The evolution of quality of life evaluations in cancer therapy. Oncology (Williston Park) 4(5):22–26 discussion 27Google Scholar
  77. Sundstrom S, Bremnes R et al (2004) Hypofractionated palliative radiotherapy (17 Gy per two fractions) in advanced non-small-cell lung carcinoma is comparable to standard fractionation for symptom control and survival: a national phase III trial. J Clin Oncol 22(5):801–810PubMedCrossRefGoogle Scholar
  78. Temel JS, Greer JA et al (2010) Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 363(8):733–742PubMedCrossRefGoogle Scholar
  79. Testa MA, Simonson DC (1996) Assesment of quality-of-life outcomes. N Engl J Med 334(13):835–840PubMedCrossRefGoogle Scholar
  80. Troxel AB, Fairclough DL et al (1998) Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med 17(5–7):653–666PubMedCrossRefGoogle Scholar
  81. van der Voort van Zyp NC, Prevost JB et al (2010) Quality of life after stereotactic radiotherapy for stage I non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 77(1):31–37CrossRefGoogle Scholar
  82. Velikova G, Booth L et al (2004) Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 22(4):714–724PubMedCrossRefGoogle Scholar
  83. Ware JE Jr, Sherbourne CD (1992) The MOS 36 item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30(6):473–483PubMedCrossRefGoogle Scholar
  84. Ware JE, Gandek B et al (1996) Evaluating instruments used cross-nationally: Methods from the IQoLA project. Quality of life and pharmacoeconimics in clinical trials. Raven Press, B. Spilker. New YorkGoogle Scholar
  85. Watkins-Bruner D, Scott C et al (1995) RTOG’s first quality of life study–RTOG 90–20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer. Int J Radiat Oncol Biol Phys 33(4):901–906PubMedCrossRefGoogle Scholar
  86. WHO (1996) Quality of life assessment. The WHOQOL group, 1994. What quality of life? The WHOQOL group. World Health Forum. WHO, Geneva 1996Google Scholar
  87. Wyrwich KW (2004) Minimal important difference thresholds and the standard error of measurement: is there a connection?. J Biopharm Stat 14(1):97–110PubMedCrossRefGoogle Scholar
  88. Wyrwich KW, Nienaber NA et al (1999a) Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care 37(5):469–478PubMedCrossRefGoogle Scholar
  89. Wyrwich KW, Tierney WM et al (1999b) Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 52(9):861–873PubMedCrossRefGoogle Scholar
  90. Wyrwich KW, Tierney WM et al (2002) Using the standard error of measurement to identify important changes on the Asthma quality of life questionnaire. Qual Life Res 11(1):1–7PubMedCrossRefGoogle Scholar
  91. Wyrwich KW, Bullinger M et al (2005) Estimating clinically significant differences in quality of life outcomes. Qual Life Res 14(2):285–295PubMedCrossRefGoogle Scholar
  92. Zee BC (1998) Growth curve model analysis for quality of life data. Stat Med 17(5–7):757–766PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  • M. Salim Siddiqui
    • 1
  • Farzan Siddiqui
    • 2
  • Benjamin Movsas
    • 1
  1. 1.Department of Radiation OncologyHenry Ford HospitalDetroitUSA
  2. 2.Department of Radiation OncologyOhio State UniversityColumbusUSA

Personalised recommendations