Annals of Oncology 25 (Supplement 4): iv517–iv541, 2014 doi:10.1093/annonc/mdu356.29
supportive care 1508P
HAEMOGLOBIN (HB) LEVELS AND QUALITY OF LIFE (QOL) IN PATIENTS (PTS) WITH SYMPTOMATIC CHEMOTHERAPY-INDUCED ANAEMIA (CIA): THE EAQUA STUDY
G. Tonini1, J. Mouysset2, B. Freier3, J. van den Bosch4, C.B. Levaché5, A. Bols6, H.W. Tessen7, L. Belton8, C. Bohac9, J. Terwey10 1 Medical Oncology, University Campus Bio-Medico, Rome, ITALY 2 Medical Oncology, Clinique Rambot Provençale, Aix en Provence, FRANCE 3 Medical Oncology, Wojewodzki Szpital Specjalistyczny, Wrocław, POLAND 4 Internal Medicine/oncology, Albert Schweitzer Hospital, Dordrecht, NETHERLANDS 5 Medical Oncology and Radiotherapy, Polyclinique Francheville, Périgueux, FRANCE 6 Oncologisch Centrum AZ Sint-Jan AV, AZ Sint-Jan Brugge-Oostende AV, Brugge, BELGIUM 7 Hematology and Oncology, Onkologische Schwerpunkpraxis, Goslar, GERMANY 8 Biostatistics, LB Biostatistics, Southall, UK 9 Clinical Reseach, Amgen Inc., Thousand Oaks, CA, USA 10 Medical Development - Oncology, Amgen (Europe) GmbH, Zug, SWITZERLAND
abstracts
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.
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