Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study

Abstract

Purpose: 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.

Conclusion: 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.

Keywords: Functional Assessment of Cancer Therapy-Fatigue subscale; darbepoetin alfa; erythropoiesis-stimulating agent; fatigue visual analog scale; transfusion.

Figure 1

Mean (95% confidence intervals) change in hemoglobin levels over time in the full analysis set. Notes: For patients with more than one hemoglobin value per study week, the mean hemoglobin value has been used. Hemoglobin measurements within 28 days after a transfusion are excluded from the analysis.

Figure 2

Time to first hemoglobin increase ≥1 g/dL in the primary analysis set. Note: Values within 28 days of a transfusion were set to missing.

Figure 3

FACT-F subscale and fatigue VAS scores over time in the full analysis set. Notes: Mean (95% confidence intervals) change in (A) FACT-F subscale scores and (B) fatigue VAS scores over time in the FAS. (A) For patients with more than one FACT-F subscale score per study week, the mean FACT-F subscale score has been used. FACT-F subscale data recorded within 28 days after an RBC transfusion were set to missing. FACT-F scores range from 0 to 52: the higher the score, the better the quality of life. (B) For patients with more than one VAS score per study week, the mean VAS score has been used. VAS data recorded within 28 days after an RBC transfusion were set to missing. VAS scores range from 0 (least fatigue) to 100 (worst fatigue). Abbreviations: FACT-F, functional assessment of cancer therapy-fatigue; FAS, full analysis set; RBC, red blood cell; VAS, visual analog scale.

Figure 4

Time to first quality of life improvement (primary analysis set). Note: Values within 28 days of a transfusion were set to missing.