Impact of azacytidine on the quality of life of patients with myelodysplastic syndrome treated in a randomized phase III trial: A Cancer and Leukemia Group B study Journal Article


Authors: Kornblith, A. B.; Herndon, J. E. 2nd; Silverman, L. R.; Demakos, E. P.; Odchimar-Reissig, R.; Holland, J. F.; Powell, B. L.; DeCastro, C.; Ellerton, J.; Larson, R. A.; Schiffer, C. A.; Holland, J. C.
Article Title: Impact of azacytidine on the quality of life of patients with myelodysplastic syndrome treated in a randomized phase III trial: A Cancer and Leukemia Group B study
Abstract: Purpose: The impact of azacytidine (Aza C) on the quality of life of 191 patients with myelodysplastic syndrome was assessed in a phase III Cancer and Leukemia Group B trial (9221). Patients and Methods: One hundred ninety-one patients (mean age, 67.5 years; 69% male) were randomized to receive either Aza C (75 mg/m2 subcutaneous for 7 days every 4 weeks) or supportive care, with supportive care patients crossing over to Aza C upon disease progression. Quality of life was assessed by centrally conducted telephone interviews at baseline and days 50, 106, and 182. Overall quality of life, psychological state, and social functioning were assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and the Mental Health Inventory (MHI). Results: Patients on the Aza C arm experienced significantly greater improvement in fatigue (EORTC, P = .001), dyspnea (EORTC, P = .0014), physical functioning (EORTC, P = .0002), positive affect (MHI, P = .0077), and psychological distress (MHI, P = .015) over the course of the study period than those in the supportive care arm. Particularly striking were improvements in fatigue and psychological state (MHI) in patients treated with Aza C compared with those receiving supportive care for patients who remained on study through at least day 106, corresponding to four cycles of Aza C. Significant differences between the two groups in quality of life were maintained even after controlling for the number of RBC transfusions. Conclusion: Improved quality of life for patients treated with Aza C coupled with significantly greater treatment response and delayed time to transformation to acute myeloid leukemia or death compared with patients on supportive care (P < .001) establishes Aza C as an important treatment option for myelodysplastic syndrome. © 2002 by American Society of Clinical Oncology.
Keywords: adult; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; acute granulocytic leukemia; major clinical study; clinical trial; disease course; mortality; quality of life; controlled clinical trial; antimetabolites, antineoplastic; randomized controlled trial; cancer research; questionnaires; dyspnea; insomnia; psychological aspect; myelodysplastic syndrome; remission induction; outcomes research; interview; phase 3 clinical trial; social aspect; crossover procedure; malignant transformation; injections, subcutaneous; azacitidine; myelodysplastic syndromes; leukemia, b-cell; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 20
Issue: 10
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2002-05-15
Start Page: 2441
End Page: 2452
Language: English
DOI: 10.1200/jco.2002.04.044
PUBMED: 12011121
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 14 November 2014 -- Source: Scopus
Altmetric
Citation Impact
MSK Authors
  1. Jimmie C B Holland
    376 Holland