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

Journal of Clinical Oncology

Volumn 21, Issue 11, 2003, Pages 2138-2146

  Hahn, Elizabeth A ^a   Glendenning, G Alastair ^a   Sorensen, Mark V ^a   Hudgens, Stacie A ^a   Druker, Brian J ^a   Guilhot, Francois ^a   Larson, Richard A ^a   O'Brien, Stephen G ^a   Dobrez, Deborah G ^a   Hensley, Martee L ^a   Cella, David ^a  

^a EVANSTON NORTHWESTERN HEALTHCARE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; CYTARABINE; IMATINIB; ANTINEOPLASTIC AGENT; PIPERAZINE DERIVATIVE; PYRIMIDINE DERIVATIVE;

ADULT; AGED; ARTICLE; CHRONIC MYELOID LEUKEMIA; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFICACY; EMOTIONALITY; HUMAN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SOCIAL ASPECT; TREATMENT OUTCOME; TREATMENT RESPONSE; WELLBEING; ADOLESCENT; COMPARATIVE STUDY; CROSSOVER PROCEDURE; FEMALE; MALE; MIDDLE AGED; MULTICENTER STUDY; MULTIVARIATE ANALYSIS; MYELOID LEUKEMIA; PROSPECTIVE STUDY; STATISTICAL MODEL;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CROSS-OVER STUDIES; CYTARABINE; FEMALE; HUMANS; INTERFERON-ALPHA; LEUKEMIA, MYELOID, CHRONIC-PHASE; LOGISTIC MODELS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PIPERAZINES; PROSPECTIVE STUDIES; PYRIMIDINES; QUALITY OF LIFE;

EID: 0038205817     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.12.154     Document Type: Article

References (54)

1. Sawyers CL: Chronic myeloid leukemia. N Engl J Med 340:1330-1340, 1999
2. Goldman JM, Druker BJ: Chronic myeloid leukemia: Current treatment options. Blood 98:2039-2042, 2001
3. Borden EC, Parkinson D: A perspective on the clinical effectiveness and tolerance of interferon-alpha. Semin Oncol 25:3-8, 1998
4. Valentine AD, Meyers CA, Kling MA, et al: Mood and cognitive side effects of interferon-alpha therapy. Semin Oncol 25:39-47, 1998
5. Trask P, Esper P, Riba M, et al: Psychiatric side effects of interferon therapy: Prevalence, proposed mechanisms, and future directions. J Clin Oncol 18:2316-2326, 2000
6. Motzer RJ, Murphy BA, Bacik J, et al: Phase III trial of interferon alfa-2a with or without 13-cis-retinoic acid for patients with advanced renal cell carcinoma. J Clin Oncol 18:2972-2980, 2000
7. Bacik J, Mazumdar M, Fairclough DL, et al: The Functional Assessment of Cancer Therapy-BRM (FACT-BRM): A new tool for the assessment of quality of life in patients treated with biologic response modifiers. Qual Life Res (in press)
8. Kantarjian HM, Deisseroth A, Kurzrock R, et al: Chronic myelogenous leukemia: A concise update. Blood 82:691-703, 1993
9. Silver RT, Woolf SH, Hehlmann R, et al: An evidence-based analysis of the effect of busulfan, hydroxyurea, interferon, and allogeneic bone marrow transplantation in treating the chronic phase of chronic myeloid leukemia: Developed for the American Society of Hematology. Blood 94:1517-1536, 1999
10. Savage DG, Antman KH: Imatinib mesylate: A new oral targeted therapy. N Engl J Med 346:683-693, 2002
11. Kantarjian HM, Sawyers C, Hochhaus A, et al: Hematologic and cytogenic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med 346:645-652, 2002
12. Talpaz M, Silver RT, Druker BJ, et al: Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: Results from a phase 2 study. Blood 99:1928-1937, 2002
13. Sawyers CL, Hochhaus A, Feldman E, et al: Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: Results of a phase II study. Blood 99:3530-3539, 2002
14. O'Brien SG, Guilhot F, Larson RA, et al: The IRIS study: International Randomized study of Interferon and low-dose Ara-C versus STI57I [imatinib] in patients with newly-diagnosed chronic phase chronic myeloid leukemia. N Engl J Med 348:994-1004, 2003
15. Mazumdar M, Back J, Cella DF, et al: Validation of FACT-BRM (Biologic Response Modifier) and handling of missing data in QOL analysis. Society for Clinical Trials (Proceedings), P112, 2000 (abstr)
16. Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer Therapy (FACT) scale: Development and validation of the general measure. J Clin Oncol 11:570-579, 1993
17. Cella DF: Manual of the Functional Assessment of Chronic Illness Therapy (FACIT Scales)-Version 4. Evanston, IL, Center on Outcomes, Research and Education (CORE), Evanston Northwestern Healthcare & Northwestern University, 1997
18. Bonomi AE, Cella DF, Hahn EA, et al: Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res 5:309-320, 1996
19. Cella D, Hernandez L, Bonomi AE, et al: Spanish language translation and initial validation of the Functional Assessment of Cancer Therapy quality-of-Iife instrument. Med Care 36:1407-1418, 1998
20. Rasch G: Probabilistic Models for Some Intelligence and Attainment Tests. Copenhagen, Denmark, Paedogogiske Institut, 1960 (reprinted by University of Chicago Press, Chicago, IL, 1980)
21. Andrich D: A rating formulation for ordered response categories. Psychometrika 43:561-573, 1978
22. Wright BD, Masters GN: Rating Scale Analysis: Rasch Measurement. Chicago, IL, MESA Press, 1982
23. Hudgens SA, Hahn EA, Glendenning A, et al: Cross-cultural validation of the Functional Assessment of Cancer Therapy for patients receiving biologic response modifiers (FACT-BRM). Qual Life Res 11:648, 2002 (abstr)
24. The EuroQol Group: EuroQol: A new facility for the measurement of health-related quality of life. Health Policy 16:199-208, 1990
25. Brooks R: EuroQol: The current state of play. Health Policy 37:53-72, 1996
26. Dolan P: Aggregating health state valuations. J Health Serv Res Policy 2:160-167, 1997
27. Dolan P: Modeling valuations for EuroQol health.states. Med Care 35:1095-1108, 1997
28. Little RJA, Rubin DB: Statistical Analysis With Missing Data. New York, NY, John Wiley & Sons, 1987
29. Troxel AB, Fairclough DL, Curran D, et al: Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med 17:653-666, 1998
30. Curran D, Bacchi M, Hsu Schmitz SF, et al: Identifying the types of missingness in quality of life data from clinical trials. Stat Med 17:739-756, 1998
31. Brown H, Prescott R: Applied Mixed Models in Medicine. New York, NY, John Wiley & Sons, 1999
32. Verbeke G, Molenberghs G: Linear Mixed Models for Longitudinal Data. New York, NY, Springer-Verlag, 2000
33. Fairclough DL: Design and Analysis of Quality of Life Studies in Clinical Trials. Boca Raton, FL, Chapman & Hall/CRC, 2002
34. Little RJA: Modeling the drop-out mechanism in repeated-measures studies. J Am Stat Assoc 90:1112-1121, 1995
35. Hedeker D, Gibbons RD: Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychol Methods 2:64-78, 1997
36. Sokal JE, Baccarani M, Russo D, et al: Staging and prognosis in chronic myelogenous leukemia. Semin Hematol 25:49-61, 1988
37. Hasford J, Pfirrmann M, Hehlmann R, et al: A new prognostic score for survival of patients with chronic myeloid leukemia treated with interferon alfa: Writing Committee for the Collaborative CML Prognostic Factors Project Group. J Natl Cancer Inst 90:850-858, 1998
38. Hahn EA, Cella D: Definition of a Meaningful Difference in the FACT-BRM. Evanston, IL, Center on Outcomes, Research and Education (CORE), Evanston Northwestern Healthcare, 2002
39. Tarlov AR: Shattuck Lecture-The increasing supply of physicians, the changing structure of the health-services system, and the future practice of medicine. N Engl J Med 308:1235-1244, 1983
40. Schroeder SA: Outcome assessment 70 years later: Are we ready? N Engl J Med 316:160-162, 1987
41. Ellwood PM: Shatluck Lecture-Outcomes management: A technology of patient experience. N Engl J Med 18:1549-1556, 1988
42. Cella DF, Tulsky DS: Quality of life in cancer. Definition, purpose, and method of measurement. Cancer Invest 11:327-336, 1993
43. Kiss TL, Abdolell M, Jamal N, et al: Long-term medical outcomes and quality-of-life assessment of patients with chronic myeloid leukemia followed at least 10 years after allogeneic bone marrow transplantation. J Clin Oncol 20:2334-2343, 2002
44. Broers S, Kaptein AA, LeCessie S, et al: Psychological functioning and quality of life following bone marrow transplantation: A 3-year follow-up study. J Psychosom Res 48:11-21, 2000
45. Kattan MW, Inoue Y, Giles FJ, et al: Cost-effectiveness of interferon-alpha and conventional chemotherapy in chronic myelogenous leukemia. Ann Intern Med 125:541-548, 1996
46. Liberato NL, Quaglini, Barosi G: Cost-effectiveness of interferon alfa in chronic myelogenous leukemia. J Clin Oncol 15:2673-2682, 1997
47. Lee SJ, Kuntz KM, Horowitz MM, et al: Unrelated donor bone marrow transplantation for chronic myelogenous leukemia: A decision analysis. Ann Intern Med 127:1080-1088, 1997
48. Beck JR, Guilhot J, Giles FJ, et al: Cytarabine added to interferon improves the cost-effectiveness of initial therapy for patients with early chronic phase chronic myelogenous leukemia. Leuk Lymphoma 41:117-124, 2001
49. Hakamies-Blomqvist L, Luoma M, Sjostrom J, et al: Quality of life in patients with metastatic breast cancer receiving either docetaxel or sequential methotrexate and 5-fluorouracil: A multicentre randomized phase III trial by the Scandinavian breast group. Eur J Cancer 36:1411-1417, 2000
50. Kramer JA, Curran D, Piccart M, et al: Randomised trial of paclitaxel versus doxorubicin as first-line chemotherapy for advanced breast cancer: Quality of life evaluation using the EORTC QLQ-C30 and the Rotterdam symptom checklist. Eur J Cancer 36:1488-1497, 2000
51. Kornblith AB, Herndon JE, Zuckerman E, et al: The impact of docetaxel, estramustine, and low dose hydrocortisone on the quality of life of men with hormone refractory prostate cancer and their partners: A feasibility study. Ann Oncol 12:633-641, 2001
52. Hobday TJ, Kugler JW, Mahoney MR, et al: Efficacy and quality-of-life data are related in a phase II trial of oral chemotherapy in previously untreated patients with metastatic colorectal carcinoma. J Clin Oncol 20:4574-4580, 2002
53. Bernhard J, Cella DF, Coates AS, et al: Missing quality of life data in cancer clinical trials: Serious problems and challenges. Stat Med 17:517-532, 1998
54. Hahn EA, Webster KA, Cella D, et al: Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: Problems and solutions. Stat Med 17:547-559, 1998