1509P - Additional haemoglobin (Hb) and quality of life (QoL) analyses from eAQUA

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Supportive Care
Presenter Giuseppe Tonini
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors G. Tonini1, J. Mouysset2, M. Rotarski3, D. Spaeth4, M. Airoldi5, C. Toganel6, C. Christofyllakis7, 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
  • 3Centre Oncologie Et De Radiothérapie, Clinique Paulmy, FR-64100 - Bayonne/FR
  • 4Medical Oncology, Centre d'Oncologie de Gentilly, 54100 - Nancy/FR
  • 5Oncology, Azienda Ospedaliera Universitaria "Città della Saluta e della Scienza" di Torino, 10126 - Torino/IT
  • 6Oncology, Spitalul Clinic Judetean de Urgenta Targu Mures, 540142 - Targu Mures/RO
  • 7Medical Oncology, 401 Military Hospital, PC11526 - Athens/GR
  • 8Biostatistics, LB Biostatistics, Southall/GB
  • 9Clinical Reseach, Amgen Inc., CA91320-1799 - Thousand Oaks/US
  • 10Medical Development - Oncology, Amgen (Europe) GmbH, 6301 - Zug/CH

Abstract

Aim

Erythropoiesis-stimulating agents (ESAs) such as darbepoetin alfa (DA) can be used to reduce the need for transfusions and improve QoL in patients (pts) with symptomatic chemotherapy-induced anaemia (CIA). eAQUA was a phase 4, prospective, observational study, assessing Hb outcome and fatigue-related QoL (electronic assessment) in pts with solid tumours who had symptomatic CIA and were receiving an ESA according to approved European indication. Primary data and detailed methodology from the eAQUA study are reported in the accompanying abstract (Tonini et al).

Methods

Additional analyses for eAQUA included: median time from baseline to an increase in Hb ≥1 g/dL or a QoL improvement (Kaplan-Meier methodology); proportion of pts with both a QoL improvement and a Hb increase ≥1 g/dL at week (wk) 9, by tumour type, and red blood cell (RBC) transfusion/iron use during the course of the study. QoL was measured in terms of Functional Assessment of Cancer Therapy-Fatigue subscale scores and fatigue Visual Analogue Scale scores.

Results

1262 pts were enrolled; the primary analysis set reported here comprised pts who received DA and had baseline and wk 9 Hb and QoL data (n = 510). Overall, 65% of pts were female, 52% were ≥65 years and 56% had competed 1-3 chemotherapy cycles. By tumour type, the proportions of pts having both a Hb increase ≥1 g/dL and QoL improvement at wk 9 were: breast (n = 152) 39% (95% confidence intervals [CI]: 31-47%); ovarian (n = 79) 38% (95% CI: 27-49%); colorectal (n = 71) 31% (95% CI: 20-42%); NSCLC (n = 70) 29% (95% CI: 18-39%) and prostate (n = 39) 28% (95% CI: 14-42%). Median times to Hb increase ≥1 g/dL or QoL improvement were 37 (95% CI: 30-43) days and 40 (95% CI: 34-43) days, respectively. Overall, 82 pts (16%) required ≥1 RBC transfusion; median Hb in the 7 days prior to transfusion was 8.3 (range: 6-12) g/dL. Overall, 163 pts (32%) required iron supplementation.

Conclusions

In our study, many pts treated with DA per current European indication for symptomatic CIA had Hb increases ≥1 g/dL and/or QoL improvements within 6 weeks of starting treatment. QoL/Hb improvements were observed across tumour types. Relatively few pts required transfusions or iron supplementation during the study.

Disclosure

G. Tonini: received Research funding from Amgen for eAQUA participation; J. Mouysset, M. Rotarski, M. Airoldi, C. Toganel and C. Christofyllakis: has received research funding from Amgen for eAQUA participation; D. Spaeth: has received research funding from Amgen for eAQUA participation and honoraria for symposia participation from Amgen; L. Belton: is a contractor funded by Amgen; C. Bohac: is an Amgen Inc. employee and stockholder; J. Terwey: is an Amgen (Europe) GmbH employee and stockholder.