Health-related quality of life assessment and reported outcomes in leukaemia randomised controlled trials - A systematic review to evaluate the added value in supporting clinical decision making

European Journal of Cancer

Volumn 44, Issue 11, 2008, Pages 1497-1506

  Efficace, Fabio ^a   Kemmler, Georg ^b   Vignetti, Marco ^a   Mandelli, Franco ^a   Molica, Stefano ^c   Holzner, Bernhard ^b  

^a Italian Group for Adult Hematologic Diseases GIMEMA Data Center   (Italy)

^b UNIVERSITY HOSPITAL INNSBRUCK   (Austria)

^c PUGLIESE CIACCIO HOSPITAL   (Italy)

Author keywords

Clinical trial; Leukaemia; Quality of life; Systematic review

Indexed keywords

ALPHA INTERFERON; CHLORAMBUCIL; CYCLOPHOSPHAMIDE; CYTARABINE; DAUNORUBICIN; FLUDARABINE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; IMATINIB;

ACUTE GRANULOCYTIC LEUKEMIA; ARTICLE; CANCER GROWTH; CANCER SURVIVAL; CHRONIC LYMPHATIC LEUKEMIA; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; DECISION MAKING; DEMOGRAPHY; DEPRESSION; DIARRHEA; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; ECZEMA; FATIGUE; HUMAN; INTERVENTION STUDY; LOW DRUG DOSE; METHODOLOGY; MONOTHERAPY; PRIORITY JOURNAL; PSYCHOMETRY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; SEXUAL BEHAVIOR; SIDE EFFECT; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TREATMENT RESPONSE; VALIDITY; WEIGHT REDUCTION;

ACUTE DISEASE; ANTINEOPLASTIC AGENTS; BONE MARROW TRANSPLANTATION; DECISION MAKING; HUMANS; LEUKEMIA; PATIENT-CENTERED CARE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 46049099564     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2008.03.017     Document Type: Article

References (47)

1. ASCO. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology. J Clin Oncol 1996;14: 671-9.
2. 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 1 (1992) 211-218
3. Efficace F., Bottomley A., Osoba D., et al. Beyond the development of health-related quality of life (HRQOL) measures. A checklist for evaluating HRQOL outcomes in cancer clinical trials-does HRQOL evaluation in prostate cancer research inform clinical decision-making?. J Clin Oncol 21 (2003) 3502-3511
4. Blazeby J.M., Avery K., Sprangers M., Pikhart H., Fayers P., and Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol 24 (2006) 3178-3186
5. Efficace F., Osoba D., Gotay C., Sprangers M., Coens C., and Bottomley A. Has the quality of health-related quality of life reporting in cancer clinical trials improved over time? Towards bridging the gap with clinical decision making. Ann Oncol 18 (2007) 775-781
6. Staquet M., Berzon R., Osoba D., and Machin D. Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res 5 (1996) 496-502
7. Chassany O., Sagnier P., Marquis P., et al. Patient-reported outcomes: the example of health related quality of life-a European guidance document for the improved integration of health related quality of life assessment in the drug regulatory process. Drug Inf J 36 (2002) 209-238
8. Gotay C.C., Korn E.L., McCabe M.S., Moore T.D., and Cheson B.D. Building quality of life assessment into cancer treatment studies. Oncology (Huntingt) 6 (1992) 25-28
9. Appelbaum F.R., Rosenblum D., Arceci R.J., et al. End points to establish the efficacy of new agents in the treatment of acute leukemia. Blood 109 (2007) 1810-1816
10. Bottomley A., and Therasse P. Quality of life in patients undergoing systemic therapy for advanced breast cancer. Lancet Oncol 3 (2002) 620-628
11. Efficace F., and Bottomley A. Health-related quality of life assessment methodology and reported outcomes in randomised controlled trials of primary brain cancer patients. Eur J Cancer 38 (2002) 1824-1831
12. Efficace F., Bottomley A., Vanvoorden V., and Blazeby J.M. Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomized controlled trials. Eur J Cancer 40 (2004) 187-197
13. Bottomley A., Efficace F., Thomas R., Vanvoorden V., and Ahmedzai S. Health-related quality of life in non small-cell lung cancer: methodologic issues in randomized controlled trials. J Clin Oncol 21 (2003) 2982-2992
14. Efficace F., Bottomley A., and van Andel G. Health-related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials. Cancer 97 (2003) 377-388
15. Molica S. Quality of life in chronic lymphocytic leukemia: a neglected issue. Leuk Lymphoma 46 (2005) 1709-1714
16. Holzner B., Kemmler G., Kopp M., Nguyen-Van-Tam D., Sperner-Unterweger B., and Greil R. Quality of life of patients with chronic lymphocytic leukemia: results of a longitudinal investigation over 1 yr. Eur J Haematol 72 (2004) 381-389
17. Levin T.T., Li Y., Riskind J., and Rai K. Depression, anxiety and quality of life in a chronic lymphocytic leukemia cohort. Gen Hosp Psychiatry 29 (2007) 251-256
18. Redaelli A., Stephens J.M., Brandt S., Botteman M.F., and Pashos C.L. Short- and long-term effects of acute myeloid leukemia on patient health-related quality of life. Cancer Treat Rev 30 (2004) 103-117
19. Schumacher A., Wewers D., Heinecke A., et al. Fatigue as an important aspect of quality of life in patients with acute myeloid leukemia. Leuk Res 26 (2002) 355-362
20. Shanafelt T.D., Bowen D., Venkat C., et al. Quality of life in chronic lymphocytic leukemia: an international survey of 1482 patients. Br J Haematol 139 (2007) 255-264
21. Mesa R.A., Niblack J., Wadleigh M., et al. The burden of fatigue and quality of life in myeloproliferative disorders (MPDs): an international Internet-based survey of 1179 MPD patients. Cancer 109 (2007) 68-76
22. Moher D., Jones A., Lepage L., and CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 285 (2001) 1992-1995
23. Efficace F., Horneber M., Lejeune S., et al. Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology. J Clin Epidemiol 59 (2006) 1257-1265
24. Stalfelt A.M. Quality of life during induction treatment of acute myeloid leukaemia. A comparison of three intensive chemotherapy regimens using three instruments for quality of life assessment. Acta Oncol 33 (1994) 477-485
25. Uyl-de Groot C.A., Löwenberg B., Vellenga E., Suciu S., Willemze R., and Rutten F.F. Cost-effectiveness and quality-of-life assessment of GM-CSF as an adjunct to intensive remission induction chemotherapy in elderly patients with acute myeloid leukemia. Br J Haematol 100 (1998) 629-636
26. Hahn E.A., Glendenning G.A., Sorensen M.V., et al. Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study. J Clin Oncol 21 (2003) 2138-2146
27. Kluin-Nelemans H.C., Buck G., le Cessie S., et al. Randomized comparison of low-dose versus high-dose interferon-alfa in chronic myeloid leukemia: prospective collaboration of 3 joint trials by the MRC and HOVON groups. Blood 103 (2004) 4408-4415
28. Catovsky D., Richards S., Matutes E., et al. Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. Lancet 370 (2007) 230-239
29. Eichhorst B.F., Busch R., Obwandner T., Kuhn-Hallek I., Herschbach P., Hallek M., and German CLL Study Group. Health-related quality of life in younger patients with chronic lymphocytic leukemia treated with fludarabine plus cyclophosphamide or fludarabine alone for first-line therapy: a study by the German CLL Study Group. J Clin Oncol 25 (2007) 1722-1731
30. Zittoun R., Suciu S., Watson M., et al. Quality of life in patients with acute myelogenous leukemia in prolonged first complete remission after bone marrow transplantation (allogeneic or autologous) or chemotherapy: a cross-sectional study of the EORTC-GIMEMA AML 8A trial. Bone Marrow Transplant 20 (1997) 307-315
31. Homewood J., Watson M., Richards S.M., Halsey J., Shepherd P.C., and Adult Leukaemia Working Party. Treatment of CML using IFN-alpha: impact on quality of life. Hematol J 4 (2003) 253-262
32. Watson M., Buck G., Wheatley K., et al., UK Medical Research Council AML 10 trial. Adverse impact of bone marrow transplantation on quality of life in acute myeloid leukaemia patients; analysis of the UK Medical Research Council AML 10 Trial. Eur J Cancer 40 (2004) 971-978
33. Perkins J.J., and Sanson-Fisher R.W. An examination of self- and telephone-administered modes of administration for the Australian SF-36. J Clin Epidemiol 51 (1998) 969-973
34. Weinberger M., Oddone E.Z., Samsa G.P., and Landsman P.B. Are health-related quality-of-life measures affected by the mode of administration?. J Clin Epidemiol 49 (1996) 135-140
35. Jorngarden A, Wettergen L, von Essen L. Measuring health-related quality of life in adolescents and young adults: Swedish normative data for the SF-36 and the HADS, and the influence of age, gender, and method of administration. Health Qual Life Outcomes 2006;14:91.
36. Weinberger M., Nagle B., Hanlon J.T., et al. Assessing health-related quality of life in elderly outpatients: telephone versus face-to-face administration. J Am Geriatr Soc 42 (1994) 1295-1299
37. Osoba D., Rodrigues G., Myles J., Zee B., and Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16 (1998) 139-144
38. O'Brien S.G., Guilhot F., Larson R.A., et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 348 (2003) 994-1004
39. Schwarz R., and Hinz A. Reference data for the quality of life questionnaire EORTC QLQ-C30 in the general German population. Eur J Cancer 37 (2001) 1345-1351
40. Eichhorst B.F., Busch R., Hopfinger G., et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood 107 (2006) 885-891
41. Allan N.C., Richards S.M., and Shepherd P.C. UK Medical Research Council randomised, multicentre trial of interferon-alpha n1 for chronic myeloid leukaemia: improved survival irrespective of cytogenetic response. The UK Medical Research Council's Working Parties for Therapeutic Trials in Adult Leukaemia. Lancet 345 (1995) 1392-1397
42. Burnett A.K., Wheatley K., Goldstone A.H., et al. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol 118 (2002) 385-400
43. Kahn S.B., Begg C.B., Mazza J.J., Bennett J.M., Bonner H., and Glick J.H. Full dose versus attenuated dose daunorubicin, cytosine arabinoside, and 6-thioguanine in the treatment of acute nonlymphocytic leukemia in the elderly. J Clin Oncol 2 (1984) 865-870
44. Bacigalupo A., Lamparelli T., Barisione G., et al. Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation. Biol Blood Marrow Transplant 12 (2006) 560-565
45. Efficace F., Novik A., Vignetti M., Mandelli F., and Cleeland C.S. Health-related quality of life and symptom assessment in clinical research of patients with haematological malignancies: where are we now and where do we go from here?. Haematologica 92 (2007) 1596-1598
46. Taphoorn M.J., Stupp R., Coens C., et al. Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol 6 (2005) 937-944
47. van Meerbeeck J.P., Gaafar R., Manegold C., et al. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol 23 (2005) 6881-6889