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Annals of Oncology<br />
1627 RETROSPECTIVE ANALYSIS OF CANCER AND<br />
CHEMOTHERAPY INDUCED ANAEMIA TREATED WITH<br />
FERRIC CARBOXYMALTOSE ONLY, AN INTRAVENOUS IRON<br />
THERAPY<br />
B. Tschechne 1 , S. Broszeit-Luft 2 , O. Harlin 3 , W.O. Jordan 2 and H. Zakaria 4<br />
1 Haematologisch-Onkologische Praxis Neustadt, Neustadt a. Rbge., GERMANY,<br />
2 Haematologisch-Onkologische Praxis Lehrte, Lehrte, GERMANY, 3 Vifor Pharma<br />
Deutschland GmbH, München, GERMANY, 4 NewConceptOncology GmbH,<br />
Lehrte, GERMANY<br />
Chemo<strong>the</strong>rapy induced anaemia is often treated with ESAs and/or blood<br />
transfusions. Oral or intravenous iron substitution represent alternatives for both<br />
cancer and chemo<strong>the</strong>rapy induced anaemia. Current discussions focus on<br />
intravenous treatment to increase Hb levels in cancer patients, as oral treatments are<br />
often associated with limited response rates and gastrointestinal side effects. This<br />
retrospective, single centre analysis investigates <strong>the</strong> effectiveness of an iv iron<br />
compound, ferric carboxymaltose (Ferinject® [FCM]) as <strong>the</strong> only anaemia treatment<br />
in an unselected, routinely treated anaemic cancer patient population between 2009<br />
and <strong>2012</strong>. Patients fulfilling <strong>the</strong> following criteria were included in <strong>the</strong> analysis:<br />
malignant cancer diagnosis, anaemia, FCM treatment ≧ 4 weeks, complete available<br />
documentation ≧ 12 weeks, no ESA or o<strong>the</strong>r iron medication and no blood<br />
transfusion during <strong>the</strong> observation period. At baseline, sex, age, tumour history,<br />
anti-tumour treatment and history of anaemia treatment during <strong>the</strong> four weeks prior<br />
<strong>the</strong> retrospective analysis were recorded. Modalities of FCM treatment and serum<br />
levels of available relevant laboratory parameters (e.g. Hb, transferrin saturation<br />
[TSAT], ferritin, haematocrit) were recorded at baseline and throughout <strong>the</strong><br />
observation period. Treatment response, tolerability and adverse reactions for a total<br />
of 59 cancer patients were investigated. The median age was 61 (20-91) years, of<br />
<strong>the</strong>se 14 were male and 45 female. During <strong>the</strong> FCM <strong>the</strong>rapy, 52 patients were not<br />
treated actively for cancer and 7 patients were on anticancer treatment. Median Hb<br />
increase was 2.0 g/dl compared to baseline (range: 0 to 6.2 g/dl). Patients received on<br />
average 336 mg iron (range: 100-1700mg). No adverse events related to FCM were<br />
recorded. The results of our retrospective analysis demonstrate <strong>the</strong> safety and<br />
effectiveness of FCM <strong>the</strong>rapy in correction of anaemia in cancer patients prior,<br />
during or after completed chemo<strong>the</strong>rapy. More long-term data on FCM exposure in<br />
cancer patients with iron deficiency are needed in order to characterize which<br />
patients benefit most from this <strong>the</strong>rapy and to determine optimal dosing and<br />
frequency of FCM use.<br />
Disclosure: B. Tschechne: I am a member of <strong>the</strong> Advisory Board of Vifor Pharma<br />
DeutschlandO. Harlin: employee of Vifor Pharma GermanyH. Zakaria: The data<br />
analysis shown was sponsored by Vifor Pharma DeutschlandAll o<strong>the</strong>r authors have<br />
declared no conflicts of interest.<br />
1628 ANEMIA POINT PREVALENCE IN PATIENTS RECEIVING<br />
CHEMOTHERAPY IN 56 CENTERS IN ITALY AND AUSTRIA<br />
L. Merlini 1 , G. Carteni 2 , S. Iacobelli 3 , C. Stelitano 4 , M. Airoldi 5 , P. Balke 6 , F. Keil 7 ,<br />
F. Haslbauer 8 , L. Belton 9 and B. Pujol 10<br />
1 Medical Oncology, Ospedale Civile S. Bortolo, Vicenza, ITALY,<br />
2 Onco-Hematology, Azienda Ospedaliera Cardarelli, Napoli, ITALY, 3 Medical<br />
Oncology, Ospedale Clinicizzato SS.Annunziata, Chieti, ITALY, 4 Hematology,<br />
Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria, ITALY, 5 Medical<br />
Oncology, Azienda Ospedaliero Universitaria Le Molinette, Torino, ITALY, 6 1st<br />
Medical Department, General Hospital St. Pölten and Karl Landsteiner Institute of<br />
Oncology, St. Pölten, AUSTRIA, 7 Hematology-Oncology, Landeskrankenhaus<br />
Leoben, Leoben, AUSTRIA, 8 Internal Medicine, Landeskrankenhaus<br />
Vöcklabruck, Vöcklabruck, AUSTRIA, 9 Biostatistics, Amgen Ltd, Uxbridge,<br />
UNITED KINGDOM, 10 Haematology/Oncology, Amgen Europe, Zug,<br />
SWITZERLAND<br />
Purpose: To evaluate <strong>the</strong> point prevalence of anemia in patients with non-myeloid<br />
tumors being treated with chemo<strong>the</strong>rapy (±radio<strong>the</strong>rapy) in a clinical practice setting.<br />
Methods: This was a cross-sectional, observational survey. Centers had to prespecify<br />
a single day, during a 4-month enrollment window, to report specific data collected<br />
as part of normal clinical practice for patients attending in relation to chemo<strong>the</strong>rapy<br />
treatment. Data for all centers/consenting patients were included in <strong>the</strong> analyses. The<br />
primary endpoint was <strong>the</strong> point prevalence of anemia as determined using a<br />
prespecified algorithm, which defined a patient as anemic based on 1) hemoglobin<br />
(Hb) ≤10 g/dL on/within 3 days prior to visit, 2) ongoing anemia treatment at visit,<br />
or 3) physician diagnosis of anemia toge<strong>the</strong>r with ≥1 anemia symptom at visit.<br />
Reasons for visit, patient demography, tumor type, systemic chemo<strong>the</strong>rapy, Hb levels,<br />
and consequences of anemia, were secondary endpoints. Patients provided informed<br />
consent where required by local regulations.<br />
Results: Between 18/11/2010-18/3/2011, data for 1412 patients were collected (Italy n<br />
= 1130 [80%]; Austria n = 282 [20%]). Of <strong>the</strong>se, 49% were men, median age was 65<br />
years and most (80%) had solid tumors (colorectal: 18%; breast: 18%; lung: 14%;<br />
prostate: 3%; o<strong>the</strong>r solid tumors: 28%). Overall, 57% of patients had received ≤3<br />
chemo<strong>the</strong>rapy cycles. The point prevalence of anemia was 32% (95% CI: 29.4%, 34.2%);<br />
14% of patients were deemed anemic based on Hb levels ≤10 g/dL, 9% based on<br />
evidence of anemia treatment and 8% based on physician assessment of anemia<br />
toge<strong>the</strong>r with ≥1 anemia symptom. Overall, 82% of patients had Hb data; <strong>the</strong> mean<br />
(SD) Hb level was 11.7 (1.7) g/dL. 32% of patients had anemia symptoms, <strong>the</strong> most<br />
common were fatigue (28%), depression (9%) and dyspnea (8%). Few patients (4%) had<br />
had <strong>the</strong>ir current chemo<strong>the</strong>rapy cycle delayed due to anemia. On visit day or ≤28 days<br />
prior, 6% of patients had evidence of whole blood or red blood cell transfusion, 13%<br />
had evidence of erythropoiesis-stimulating agent use and 6% had evidence of iron use.<br />
Conclusions: In this survey one-third of patients with non-myeloid tumors<br />
undergoing chemo<strong>the</strong>rapy were found to be anemic on <strong>the</strong> prespecified study day.<br />
Disclosure: L. Belton: Contract worker for Amgen Ltd, B. Pujol: Employed by<br />
Amgen EuropeAll o<strong>the</strong>r authors have declared no conflicts of interest.<br />
1629 HIGH PREVALENCE AND INCIDENCE OF ANAEMIA IN<br />
CANCER PATIENTS IN SPAIN<br />
P. Gascón 1 , A. Casas 2 , J. Muñoz 3 , J. De Castro 4 , V. Alberola 5 , M. Cucala 6 and<br />
F. Barón 7<br />
1 Medical Oncology Department, Hospital Clínic i Provincial de Barcelona,<br />
Barcelona, SPAIN, 2 Medical Onology Department, Hospital Virgen del Rocío,<br />
Sevilla, SPAIN, 3 Medical Oncology Department, Hospital Dr. Peset, Valencia,<br />
SPAIN, 4 Medical Oncology Department, Hospital La Paz, Madrid, SPAIN,<br />
5 Medical Oncology Department, Hospital Arnau de Vilanova, Valencia, SPAIN,<br />
6 Medical Advisor, Vifor Pharma España, Barcelona, SPAIN, 7 Medical Oncology<br />
Department, Complejo hospitalario Universitario de Santiago de Compostela,<br />
Santiago de Compostela, SPAIN<br />
Background: Anaemia is a frequent complication in cancer patients. This<br />
haematological abnormality may be related to cancer itself and/or induced by<br />
chemo<strong>the</strong>rapy. The objective of <strong>the</strong> present study was to describe <strong>the</strong> prevalence of<br />
anaemia in treatment-naïve patients with solid tumours, <strong>the</strong> incidence of anaemia<br />
after four months of cancer treatment and anaemia management.<br />
Methods: Multicenter, prospective and observational study that included newly<br />
diagnosed cancer patients. Data on anaemia parameters and its management were<br />
collected at baseline and after four months of cancer treatment. The primary<br />
outcome was <strong>the</strong> proportion of patients with anaemia defined as a haemoglobin (Hb)<br />
concentration