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Additional Haemoglobin (Hb) and Quality of Life (Qol) Analyses from Eaqua
Annals of Oncology 25 (Supplement 4): iv517–iv541, 2014 doi:10.1093/annonc/mdu356.30
supportive care 1509P
ADDITIONAL HAEMOGLOBIN (HB) AND QUALITY OF LIFE (QOL) ANALYSES FROM EAQUA
abstracts
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).
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv527/2242196 by guest on 24 October 2019
G. Tonini1, J. Mouysset2, M. Rotarski3, D. Spaeth4, M. Airoldi5, C. Toganel6, C. Christofyllakis7, 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 Centre Oncologie et de Radiothérapie, Clinique Paulmy, Bayonne, FRANCE 4 Medical Oncology, Centre d’Oncologie de Gentilly, Nancy, FRANCE 5 Oncology, Azienda Ospedaliera Universitaria "Città della Saluta e della Scienza" di Torino, Turin, ITALY 6 Oncology, Spitalul Clinic Judetean de Urgenta Targu Mures, Targu Mures, ROMANIA 7 Medical Oncology, 401 Military Hospital, Athens, GREECE 8 Biostatistics, LB Biostatistics, Southall, UK 9 Clinical Reseach, Amgen Inc., Thousand Oaks, CA, USA 10 Medical Development - Oncology, Amgen (Europe) GmbH, Zug, SWITZERLAND
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.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
supportive care 1509P
ADDITIONAL HAEMOGLOBIN (HB) AND QUALITY OF LIFE (QOL) ANALYSES FROM EAQUA
abstracts
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).
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv527/2242196 by guest on 24 October 2019
G. Tonini1, J. Mouysset2, M. Rotarski3, D. Spaeth4, M. Airoldi5, C. Toganel6, C. Christofyllakis7, 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 Centre Oncologie et de Radiothérapie, Clinique Paulmy, Bayonne, FRANCE 4 Medical Oncology, Centre d’Oncologie de Gentilly, Nancy, FRANCE 5 Oncology, Azienda Ospedaliera Universitaria "Città della Saluta e della Scienza" di Torino, Turin, ITALY 6 Oncology, Spitalul Clinic Judetean de Urgenta Targu Mures, Targu Mures, ROMANIA 7 Medical Oncology, 401 Military Hospital, Athens, GREECE 8 Biostatistics, LB Biostatistics, Southall, UK 9 Clinical Reseach, Amgen Inc., Thousand Oaks, CA, USA 10 Medical Development - Oncology, Amgen (Europe) GmbH, Zug, SWITZERLAND
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.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].