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: OBJECTIVE
  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).
  
  
  METHODS
  One hundred ninety-one patients (mean age, 67.5 years; 69% male) were randomized to receive either Aza C (75 mg/m(2) 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.
  
  
  CONCLUSIONS
  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.
authors: Women's Cancers Program, Dana-Farber Cancer Institute, Rm. D1210, 44 Binney Street, Boston, MA 02115, USA. Alice_Kornblith@dfci.harvard.edu
authors: Alice B
authors: AB
authors: Kornblith
authors: James E
authors: JE
authors: Herndon
authors: Lewis R
authors: LR
authors: Silverman
authors: Erin P
authors: EP
authors: Demakos
authors: Rosalie
authors: R
authors: Odchimar-Reissig
authors: James F
authors: JF
authors: Holland
authors: Bayard L
authors: BL
authors: Powell
authors: Carlos
authors: C
authors: DeCastro
authors: John
authors: J
authors: Ellerton
authors: Richard A
authors: RA
authors: Larson
authors: Charles A
authors: CA
authors: Schiffer
authors: Jimmie C
authors: JC
authors: Holland
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001374:Azacitidine / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D015448:Leukemia, B-Cell / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012074:Remission Induction; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine