1508P - Haemoglobin (Hb) levels and quality of life (QoL) in patients (pts) with symptomatic chemotherapy-induced anaemia (CIA): The eAQUA study

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Supportive Care
Presenter Giuseppe Tonini
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors G. Tonini1, J. Mouysset2, B. Freier3, J. van den Bosch4, C.B. Levaché5, A. Bols6, H.W. Tessen7, L. Belton8, C. Bohac9, J. Terwey10
  • 1Medical Oncology, University Campus Bio-Medico, 00128 - Rome/IT
  • 2Medical Oncology, Clinique Rambot Provençale, 13100 - Aix en Provence/FR
  • 3Medical Oncology, Wojewodzki Szpital Specjalistyczny, 51-124 - Wrocław/PL
  • 4Internal Medicine/oncology, Albert Schweitzer Hospital, 3300 AK - Dordrecht/NL
  • 5Medical Oncology And Radiotherapy, Polyclinique Francheville, 24000 - Périgueux/FR
  • 6Oncologisch Centrum Az St Jan Av, AZ Sint-Jan Brugge-Oostende AV, 8000 - Brugge/BE
  • 7Hematology And Oncology, Onkologische Schwerpunkpraxis, 38642 - Goslar/DE
  • 8Biostatistics, LB Biostatistics, UB2 5AZ - Southall/GB
  • 9Clinical Reseach, Amgen Inc., CA91320-1799 - Thousand Oaks/US
  • 10Medical Development - Oncology, Amgen (Europe) GmbH, 6301 - Zug/CH

Abstract

Aim

Fatigue is common in pts with CIA and can adversely impact QoL. There are limited data related to improvements in Hb levels and fatigue-related QoL in routine clinical practice.

Methods

eAQUA was a phase 4, prospective, observational study assessing Hb outcome and fatigue-related QoL (electronic assessment) in pts with solid tumours receiving chemotherapy who had symptomatic CIA and were receiving an erythropoiesis-stimulating agent according to European indications. The primary aim was to determine the proportion of pts receiving darbepoetin alfa (DA) with a Hb increase ≥1 g/dL and improved QoL between baseline and week (wk) 9. Pts receiving DA who had baseline and wk 9 Hb and QoL data represented the primary analysis set (PAS). QoL was measured in terms of Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale scores and fatigue Visual Analogue Scale (VAS) scores (0=least fatigued). FACT-F change scores were anchored to VAS change scores to determine the minimally important difference (MID) for a perceived QoL improvement, based on a predefined algorithm. Pts who had a FACT-F change score ≥ the calculated MID were deemed to have improved QoL.

Results

1262 pts were enrolled; 510 pts were included in the PAS. At baseline, median age was 65 years, 30% had been diagnosed with breast cancer, 69% had stage IV disease and 96% were experiencing fatigue. At baseline, mean (SD) Hb was 9.4 (0.6) g/dL; mean (SD) FACT-F and VAS scores were 29.2 (10.3) and 49.2 (22.6), respectively. Mean (SD) change from baseline in Hb at wk 9 was 1.2 (1.4) g/dL; mean (SD) change in FACT-F and VAS scores were 3.5 (10.5) and 4.3 (24.7). The mean (SD) FACT-F change determined to be the MID for a QoL improvement was 3.5 (5.5). Overall, 32% (95% CI: 28-36%) of pts met the primary endpoint with both a Hb increase ≥1 g/dL and improved QoL at wk 9. The proportions of pts achieving either improvements in QoL or Hb ≥1 g/dL at wk 9 were 49% and 58%; 70% and 76% of pts had improvements in QoL or Hb levels at any time up to end of study.

Conclusions

In our study, pts with solid tumours receiving DA per European indication for symptomatic CIA had a clinically meaningful improvement in both Hb levels and QoL.

Disclosure

G. Tonini, J. Mouysset, B. Freier, J. van den Bosch, A. Bols and H.W. Tessen: Research funding from Amgen for eAQUA participation; C.B. Levaché: is voluntary Président of association called “association pour la recherche clinique de francheville”, which received a payment on behalf of AMGEN to realize the e-aqua study; L. Belton: Contractor funded by Amgen; C. Bohac: Amgen Inc. employee and stockholder; J. Terwey: Amgen (Europe) GmbH employee and stockholder.