title: Quality-of-life and health benefits of early treatment of mild anemia: a randomized trial of epoetin alfa in patients receiving chemotherapy for hematologic malignancies.
abstract: BACKGROUND
  Chemotherapy-related anemia is prevalent among patients with hematologic malignancies. A randomized, open-label, multicenter trial of early versus late epoetin alfa in this population was conducted, focusing on quality of life (QOL).
  
  
  METHODS
  Patients with non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma and baseline hemoglobin of 10 to 12 g/dL who were scheduled for > or = 4 months of myelosuppressive chemotherapy were randomized to receive < or = 16 weeks of epoetin alfa at a dose of 40,000 U once weekly immediately (early) or to wait and only receive epoetin alfa if hemoglobin decreased to < 9 g/dL (late). Those patients with a hemoglobin level > 12 g/dL after 3 chemotherapy cycles were not randomized. The primary endpoint was a mean change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) total.
  
  
  RESULTS
  In all, 269 patients with a hemoglobin level < or = 12 g/dL were randomized. The mean total FACT-An increased 3.84 (95% confidence interval [95% CI], 0.21-7.46) in early patients and decreased 4.37 (95% CI, -7.99 to -0.74) in late patients (P = .003). Early patients had significantly (P < .05) higher mean scores for total FACT-General; FACT-General physical and functional well-being subscales, total anemia scale, and fatigue subscale; and daily activity, energy, and important activity Linear Analog Scale Assessment scales, as well as reduced bedrest days and restricted activity days. The mean hemoglobin increased 1.2 g/dL (95% CI, 0.98-1.46) in early patients but decreased 0.2 g/dL (95% CI, -0.32-0.12) in late patients (P < .0001). Adverse events were similar between groups (with fatigue being the most prevalent); clinically relevant thromboembolic events were more common in early patients.
  
  
  CONCLUSIONS
  Treating mild anemia immediately with epoetin alfa during chemotherapy for hematologic malignancy significantly improved QOL, productivity, and hemoglobin compared with delaying treatment until the hemoglobin level decreases to < 9.0 g/dL.
authors.affiliation: Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA. strausd@mskcc.org
authors.forename: David J
authors.initials: DJ
authors.lastname: Straus
authors.forename: Marcia A
authors.initials: MA
authors.lastname: Testa
authors.forename: Brenda J
authors.initials: BJ
authors.lastname: Sarokhan
authors.forename: Myron S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: Anil
authors.initials: A
authors.lastname: Tulpule
authors.forename: Ralph R
authors.initials: RR
authors.lastname: Turner
authors.forename: Shirley A
authors.initials: SA
authors.lastname: Riggs
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy* / Q000517:prevention & control; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D005221:Fatigue / Q000453:epidemiology; D005260:Female; D019337:Hematologic Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins; D014938:Work Capacity Evaluation
chemical_list: D000970:Antineoplastic Agents; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa