The prognostic significance of patient-reported outcomes in cancer clinical trials

Journal of Clinical Oncology

Volumn 26, Issue 8, 2008, Pages 1338-1345

  Gotay, Carolyn C ^a   Kawamoto, Crissy T ^a   Bottomley, Andrew ^a   Efficace, Fabio ^a  

^a UNIVERSITY OF HAWAII CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; CANCER GROWTH; CANCER MORTALITY; CANCER SURGERY; CANCER SURVIVAL; FEMALE; GLIOMA; HEMISPHERE; HUMAN; MAJOR CLINICAL STUDY; MALE; MALIGNANT TRANSFORMATION; OVERALL SURVIVAL; POSTOPERATIVE PERIOD; PREOPERATIVE EVALUATION; PRIORITY JOURNAL; PROGNOSIS; RETROSPECTIVE STUDY; TREATMENT OUTCOME; TUMOR VOLUME;

EID: 51349086894     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.13.9337     Document Type: Article

References (64)

1. Lipscomb J, Gotay CC, Snyder C: Outcomes Assessment in Cancer. Cambridge, MA, Cambridge University Press, 2005
2. United States Food and Drug Administration: Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville, MD, United States Food and Drug Administration, 2006
3. Hauser CA, Stockler MR, Tattersall MH: Prognostic factors in patients with recently diagnosed incurable cancer: A systematic review. Support Care Cancer 14:999-1011, 2006
4. Osoba D: Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol 12:608-616, 1994
5. Sprangers MA: Quality-of-life assessment in oncology: Achievements and challenges. Acta Oncol 41:229-237, 2002
6. Brown J, Thorpe H, Napp V, et al: Assessment of quality of life in the supportive care setting of the big lung trial in non-small-cell lung cancer. J Clin Oncol 23:7417-7427, 2005
7. Brown PD, Ballman KV, Rummans TA, et al: Prospective study of quality of life in adults with newly diagnosed high-grade gliomas. J Neurooncol 76:283-291, 2006
8. Chau I, Norman AR, Cunningham D, et al: Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer: Pooled analysis from three multicenter, randomized, controlled trials using individual patient data. J Clin Oncol 22:2395-2403, 2004
9. Chiarion-Sileni V, Del Bianco P, De Salvo GL, et al: Quality of life evaluation in a randomised trial of chemotherapy versus bio-chemotherapy in advanced melanoma patients. Eur J Cancer 39:1577-1585, 2003
10. Coates A, Gebski V, Signorini D, et al: Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer: Australian New Zealand Breast Cancer Trials Group. J Clin Oncol 10:1833-1838, 1992
11. Coates A, Thomson D, McLeod GR, et al: Prognostic value of quality of life scores in a trial of chemotherapy with or without interferon in patients with metastatic malignant melanoma. Eur J Cancer 12:1731-1734, 1993
12. Coates AS, Hurny C, Peterson HF, et al: Quality-of-life scores predict outcome in metastatic but not early breast cancer: International Breast Cancer Study Group. J Clin Oncol 18:3768-3774, 2000
13. Collette L, Van Andel G, Bottomley A, et al: Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organization for Research and Treatment of Cancer Genitourinary Group. J Clin Oncol 22:3877-3885, 2004
14. Dancey J, Zee B, Osoba D, et al: 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 6:151-158, 1997
15. Dubois D, Dhawan R, van de Velde H, et al: Descriptive and prognostic value of patient-reported outcomes: The bortezomib experience in relapsed and refractory multiple myeloma. J Clin Oncol 24:976-982, 2006
16. Efficace F, Biganzoli L, Piccart M, et al: Baseline health-related quality-of-life data as prognostic factors in a phase III multicentre study of women with metastatic breast cancer. Eur J Cancer 40:1021-1030, 2004
17. Efficace F, Bottomley A, Coens C, et al: Does a patient's self-reported health-related quality of life predict survival beyond key biomedical data in advanced colorectal cancer? Eur J Cancer 42:42-49, 2006
18. Efficace F, Therasse P, Piccart MJ, et al: Health-related quality of life parameters as prognostic factors in a nonmetastatic breast cancer population: An international multicenter study. J Clin Oncol 22:3381-3388, 2004
19. Eton DT, Fairclough DL, Cella D, et al: Early change in patient-reported health during lung cancer chemotherapy predicts clinical outcomes beyond those predicted by baseline report: Results from Eastern Cooperative Oncology Group Study 5592. J Clin Oncol 21:1536-1543, 2003
20. Fossa° SD, Paus E, Lindegaard M, et al: Prostate-specific antigen and other prognostic factors in patients with hormone-resistant prostatic cancer undergoing experimental treatment. Br J Urol 69:175-179, 1992
21. Ganz PA, Lee JJ, Siau J: Quality of life assessment: An independent prognostic variable for survival in lung cancer. Cancer 67:3131-3135, 1991
22. Herndon JE 2nd, Fleishman S, Kornblith AB, et al: Is quality of life predictive of the survival of patients with advanced nonsmall cell lung carcinoma? Cancer 85:333-340, 1999
23. Jerkeman M, Kaasa S, Hjermstad M, et al: Health-related quality of life and its potential prognostic implications in patients with aggressive lymphoma: A Nordic Lymphoma Group Trial. Med Oncol 18:85-94, 2001
24. Kaasa S, Mastekaasa A, Lund E: 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 15:235-242, 1989
25. Kramer JA, Curran D, Piccart M, et al: Identification and interpretation of clinical and quality of life prognostic factors for survival and response to treatment in first-line chemotherapy in advanced breast cancer. Eur J Cancer 36:1498-1506, 2000
26. Langendijk H, Aaronson NK, de Jong JM, et al: 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 55:19-25, 2000
27. Loprinzi CL, Laurie JA, Wieand HS, et al: Prospective evaluation of prognostic variables from patient-completed questionnaires: North Central Cancer Treatment Group. J Clin Oncol 12:601-607, 1994
28. Maione P, Perrone F, Gallo C, et al: Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: A prognostic analysis of the multicenter Italian lung cancer in the elderly study. J Clin Oncol 23:6865-6872, 2005
29. Maisey NR, Norman A, Watson M, et al: Baseline quality of life predicts survival in patients with advanced colorectal cancer. Eur J Cancer 38:1351-1357, 2002
30. Meyers CA, Hess KR, Yung WK, et al: Cognitive function as a predictor of survival in patients with recurrent malignant glioma. J Clin Oncol 18:646-650, 2000
31. Moinpour CM, Lyons B, Grevstad PK, 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
32. Monk BJ, Huang HQ, Cella D, et al: Quality of life outcomes from a randomized phase III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: A Gynecologic Oncology Group Study. J Clin Oncol 23:4617-4625, 2005
33. Naughton MJ, Herndon JE 2nd, Shumaker SA, et al: The health-related quality of life and survival of small-cell lung cancer patients: Results of a companion study to CALGB 9033. Qual Life Res 11:235-248, 2002
34. Nowak AK, Stockler MR, Byrne MJ: Assessing quality of life during chemotherapy for pleural mesothelioma: Feasibility, validity, and results of using the European organization for research and treatment of cancer core quality of life questionnaire and lung cancer module. J Clin Oncol 22:3172-3180, 2004
35. Roychowdhury DF, Hayden A, Liepa AM: Health-related quality-of-life parameters as independent prognostic factors in advanced or metastatic bladder cancer. J Clin Oncol 21:673-678, 2003
36. Ruckdeschel JC, Piantadosi S: Quality of life in lung cancer surgical adjuvant trials. Chest 106:324S-328S, 1994
37. Seidman AD, Portenoy R, Yao TJ, et al: Quality of life in phase II trials: A study of methodology and predictive value in patients with advanced breast cancer treated with paclitaxel plus granulocyte colony-stimulating factor. J Natl Cancer Inst 87:1316-1322, 1995
38. Sullivan PW, Nelson JB, Mulani PM, et al: Quality of life as a potential predictor for morbidity and mortality in patients with metastatic hormone-refractory prostate cancer. Qual Life Res 15:1297-1306, 2006
39. Tannock IF, Osoba D, Stockler MR, et al: Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: A Canadian randomized trial with palliative end points. J Clin Oncol 14:1756-1764, 1996
40. Tross S, Herndon J 2nd, Korzun A, et al: Psychological symptoms and disease-free and overall survival in women with stage II breast cancer: Cancer and Leukemia Group B. J Natl Cancer Inst 88:661-667, 1996
41. Winer EP, Berry DA, Woolf S, et al: Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: Cancer and leukemia group B trial 9342. J Clin Oncol 22:2061-2068, 2004
42. Wisløff F, Hjorth M: Health-related quality of life assessed before and during chemotherapy predicts for survival in multiple myeloma: Nordic Myeloma Study Group. Br J Haematol 97:29-37, 1997
43. Efficace F, Bottomley A, Smit EF, et al: Is a patient's self-reported health-related quality of life a prognostic factor for survival in non-small-cell lung cancer patients? A multivariate analysis of prognostic factors of EORTC study 08975. Ann Oncol 17:1698-1704, 2006
44. Yeo W, Mo FK, Koh J, et al: Quality of life is predictive of survival in patients with unresectable hepatocellular carcinoma. Ann Oncol 17:1083-1089, 2006
45. Spilker B: Quality of Life and Pharmacoeconomics in Clinical Trials (ed 2). Philadelphia, PA, Lippincott-Raven, 1996
46. Curry SJ, Byers T, Hewitt ME: Fulfilling the Potential for Cancer Prevention and Early Detection. Washington, DC, National Academies Press, 2003
47. Ganz PA, Goodwin PJ: Quality of life in breast cancer: What have we learned and where do we go from here? in Lipscomb J, Gotay CC, Snyder C (eds): Outcomes Assessment in Cancer. Cambridge, MA, Cambridge University Press, 2005, pp 93-125
48. Gotay CC: Increasing trial generalizability. J Clin Oncol 24:846-847, 2006
49. Osoba D: The clinical value and meaning of health-related quality-of-lie outcomes in oncology, in Lipscomb J, Gotay CC, Snyder C (eds): Outcomes Assessment in Cancer. Cambridge, MA, Cambridge University Press, 2005, pp 386-405
50. Sneeuw KC, Sprangers MA, Aaronson NK: The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease. J Clin Epidemiol 55:1130-1143, 2002
51. Morton RF, Sloan JA, Grothey A, et al: A comparison of simple single-item measures and the common toxicity criteria in detecting the onset of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. J Clin Oncol 23:750s, 2005 (suppl; abstr 8087)
52. Courneya KS, Segal RJ, Reid RD, et al: Three independent factors predicted adherence in a randomized controlled trial of resistance exercise training among prostate cancer survivors. J Clin Epidemiol 57:571-579, 2004
53. Kiecolt-Glaser JK, Robles TF, Heffner KL, et al: Psycho-oncology and cancer: Psychoneuroimmunology and cancer. Ann Oncol 13:165-169, 2002 (suppl 4)
54. Kemeny ME: An interdisciplinary research model to investigate psychosocial cofactors in disease: Application to HIV-1 pathogenesis. Brain Behav Immun 17:S62-72, 2003 (suppl 1)
55. Osoba D: Measuring the effect of cancer on health-related quality of life. Pharmacoeconomics 7:308-319, 1995
56. Goodwin PJ, Leszcz M, Ennis M, et al: The effect of group psychosocial support on survival in metastatic breast cancer. N Engl J Med 345:1719-1726, 2001
57. Spiegel D, Bloom JR, Kraemer HC, et al: Effect of psychosocial treatment on survival of patients with metastatic breast cancer. Lancet 2:888-891, 1989
58. Rummans TA, Clark MM, Sloan JA, et al: Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: A randomized controlled trial. J Clin Oncol 24:635-642, 2006
59. Singh JA, Nelson DB, Fink HA, et al: Health-related quality of life predicts future health care utilization and mortality in veterans with self-reported physician-diagnosed arthritis: The veterans arthritis quality of life study. Semin Arthritis Rheum 34:755-765, 2005
60. Fan VS, Curtis JR, Tu SP, et al: Using quality of life to predict hospitalization and mortality in patients with obstructive lung diseases. Chest 122:429-436, 2002
61. Cunningham WE, Crystal S, Bozzette S, et al: The association of health-related quality of life with survival among persons with HIV infection in the United States. J Gen Intern Med 20:21-27, 2005
62. Mapes DL, Lopes AA, Satayathum S, et al: Health-related quality of life as a predictor of mortality and hospitalization: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int 64:339-349, 2003
63. Fan VS, Au DH, McDonell MB, et al: Intraindividual change in SF-36 in ambulatory clinic primary care patients predicted mortality and hospitalizations. J Clin Epidemiol 57:277-283, 2004
64. Dorr DA, Jones SS, Burns L, et al: Use of health-related, quality-of-life metrics to predict mortality and hospitalizations in community-dwelling seniors. J Am Geriatr Soc 54:667-673, 2006