Clinical use of ferric carboxymaltose in patients with solid tumours or haematological malignancies in France.
OBJECTIVE
This study collected data on the use of ferric carboxymaltose (FCM) in a cancer patient population in France to evaluate the feasibility and the conditions of use of FCM in routine clinical practice beyond the limiting criteria of clinical trials.


METHODS
This observational, prospective study of patients with a solid tumour or a haematological malignancy who have received treatment with FCM after 01 July 2011 evaluated data about the circumstances of iron administration, concomitant medication and laboratory tests in the period from 3 months prior to the first FCM administration (baseline) until 3 months post-baseline.


RESULTS
Data from 367 FCM-treated patients were analysed. FCM was mainly given as a single dose at baseline (69.2%) and without additional erythropoiesis-stimulating agent (ESA, 64.3%). The median total iron dose was 1000 mg per patient. Median haemoglobin (Hb) levels of FCM-treated patients improved from 10.3 g/dL (interquartile range 9.5, 11.1 g/dL) at baseline to 11.8 g/dL (11.1, 13.0 g/dL) until the end of the 3-month observational period. Patients treated with FCM alone or additional ESA achieved similar median Hb increase (1.3 [0.4, 2.1] g/dL and 1.4 [0.4, 2.5] g/dL, respectively). Patients with baseline Hb up to 11.0 g/dL and serum ferritin up to 500 ng/mL and beyond achieved stable median Hb levels ≥11.0 g/dL without signs of iron overload. No severe or serious adverse reaction and no hypersensitivity reactions were reported.


CONCLUSIONS
The results of this observational study confirm the effectiveness and tolerability of FCM when given in clinical routine practice alone or in combination with an ESA.
American Hospital of Paris, 63, Bd Victor Hugo, 92200, Neuilly-sur-Seine, France. alain.toledano@ahparis.org.
Alain
A
Toledano
Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France.
Elisabeth
E
Luporsi
Hôpital Avicenne, Bobigny, France.
Jean François
JF
Morere
Hôpital Européen Georges-Pompidou, Paris, France.
Florian
F
Scotté
Centre Hospitalier Le Mans Cedex 9, Le Mans, France.
Kamel
K
Laribi
Centre Antoine Lacassagne, Nice, France.
Jérôme
J
Barrière
ICTA, Fontaine-les-Dijon, France.
Philippe
P
Huot-Marchand
Vifor Pharma, Neuilly-sur-Seine Cedex, France.
Ladan
L
Duvillié
Vifor Pharma, Neuilly-sur-Seine Cedex, France.
Victor Hugo
VH
Concas
Institut Claudius Regaud, Toulouse, France.
Roland
R
Bugat
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000139:chemically induced* / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D005602:France; D006397:Hematinics / Q000627:therapeutic use*; D019337:Hematologic Neoplasms / Q000188:drug therapy; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007501:Iron; D008297:Male; D008320:Maltose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult
D000970:Antineoplastic Agents; D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; C522335:ferric carboxymaltose; D008320:Maltose; D007501:Iron
Anaemia; Chemotherapy-induced anaemia; Erythropoiesis-stimulating agent; Ferric carboxymaltose; Haemoglobin; Intravenous; Iron; Iron deficiency