title: Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study.
abstract: OBJECTIVE
  To assess hemoglobin (Hb) outcomes and fatigue-related quality-of-life (QoL) (electronic assessment) in patients with solid tumors and symptomatic chemotherapy-induced anemia receiving cytotoxic chemotherapy and darbepoetin alfa (DA) or another erythropoiesis-stimulating agent according to European indication.
  
  
  METHODS
  eAQUA was a Phase IV prospective observational study. The primary outcome (assessed in the primary analysis set [PAS]: patients receiving one or more DA dose who had baseline and week 9 assessments for Hb and QoL) was the proportion of patients receiving DA having both Hb increases ≥1 g/dL and improved QoL between baseline and week 9. Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale scores were anchored to fatigue visual analog scale scores to determine the minimally important difference for improved QoL. Overall data/data over time are reported for the full analysis set (patients receiving one or more erythropoiesis-stimulating agent dose, n=1,158); week 9 data (ie, data relating to the primary and secondary outcomes) are reported for the PAS (n=510). Baseline and safety data are included for both the full analysis set and PAS.
  
  
  RESULTS
  In the PAS, 69% of patients had stage IV disease and 96% were fatigued. The minimally important difference in FACT-F change score for QoL improvement was 3.5. From baseline to week 9, 32% (95% confidence interval: 28%-36%) of patients had both improved QoL and an Hb increase ≥1 g/dL; proportions were similar across the most common tumor types. At week 9, 49% and 58% of patients had improved QoL or Hb increases ≥1 g/dL, respectively; 70% and 76% had QoL or Hb improvements between baseline and study end, respectively. In the PAS, 16% of patients required transfusions and 32% required iron supplementation. Few patients (<1%) reported adverse drug reactions.
  
  
  CONCLUSIONS
  In this study, patients with solid tumors receiving DA per European indication for symptomatic chemotherapy-induced anemia had clinically meaningful improvements in Hb and QoL.
authors: Department of Medical Oncology, Clinique Rambot Provencale, Aix en Provence, France.
authors: Jean-Loup
authors: JL
authors: Mouysset
authors: Clinical Oncology, Wojewodzki Szpital Specjalistyczny, Wroclaw, Poland.
authors: Beata
authors: B
authors: Freier
authors: Department of Internal Medicine/Oncology, Albert Schweitzer Ziekenhuis locatie Dordwijk, Dordrecht, the Netherlands.
authors: Joan
authors: J
authors: van den Bosch
authors: Radiotherapy Service, Medical Oncology, Polyclinique Francheville, Périgueux, France.
authors: Charles Briac
authors: CB
authors: Levaché
authors: Central Pharmacy, AZ Sint-Jan Brugge-Oostende AV, Brugge, Belgium.
authors: Alain
authors: A
authors: Bols
authors: Private Oncology Practice. Goslar, Germany.
authors: Hans Werner
authors: HW
authors: Tessen
authors: LB Biostatistics, London, UK.
authors: Laura
authors: L
authors: Belton
authors: Clinical Research, Amgen Inc., Thousand Oaks, CA, USA.
authors: G Chet
authors: GC
authors: Bohac
authors: Medical Development - Oncology, Amgen (Europe) GmbH, Zug, Switzerland.
authors: Jan-Henrik
authors: JH
authors: Terwey
authors: Department of Medical Oncology, Università Campus Bio-Medico, Roma, Italy.
authors: Giuseppe
authors: G
authors: Tonini
keywords: Functional Assessment of Cancer Therapy-Fatigue subscale; darbepoetin alfa; erythropoiesis-stimulating agent; fatigue visual analog scale; transfusion