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Clinical use of ferric carboxymaltose in patients with solid tumours or haematological malignancies in France

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Abstract

Purpose

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.

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Acknowledgments

Preparation and conduct of the study have been sponsored by Vifor France SA. Data Management and biostatistical analyses were performed by ICTA PM, France, and funded by Vifor France SA. Medical writing support in the preparation of the manuscript was provided by Walter Fürst, SFL Regulatory Affairs & Scientific Communication, Switzerland, and funded by Vifor Pharma Ltd., Switzerland. The manuscript was reviewed and commented by Beate Rzychon (Vifor Pharma Ltd., Glattbrugg, Switzerland). The authors would like to thank the local investigators who actively participated in this study: Grégory Dendleux, Centre Hospitalier Pierre Oudot; Gérard Dine, Saïd Brahimi, Audrey Echegasd and Nadia Ali Amar, Centre Hospitalier Troyes; Jean-Loup Mouysset, Clinique Rambot-Provencale; Abderraouf Radji, Centre Frederic Joliot; Laurent Zelek, Kader Chouahnia, Gaetan Des Guetz, Marie-Christine Pailler and Thierry Bouillet, Hopital Avicenne; Pierre Bory, Centre Hospitalier Bastia Cedex; Mihaela Achille, Emmanuel Achille and France Campos, Institut De Cancerologie Prive De L'orangerie; Hamah Lamallem, Hopital Americain De Paris; Faress Husseini, Hopital Louis Pasteur; Claude Boiron, Anne Donnadieu, Centre Rene Huguenin; Bertrand Mennecier, Nouvel Hopital Civil; Jean-Philippe Wagner, Centre De Radiothérapie De Dunkerque; Jérôme Dauba, Hopital Layne; Isabelle Gabelle, Chu De Grenoble; Joel Castelli, Pascale Revole and Pascal Bourlet, Centre Hospitalier De Castelluccio; Younes El Masmoudi, Clinique Des Murlins; Delphine Borchiellini and Axel Leysalle, Centre Antoine Lacassagne; Dominique Jaubert, Nathalie Bonichon-Lamichhane, Hortense Laharie and Christophe Debelleix, Clinique Tivoli; Alain Zannetti and Elouen Boughalem, Centre Hospitalier Cholet Cedex; Louis-Marie Dourthe, Clinique Sainte Anne; Anne Floquet, Dominique Bechade and Marie Sire, Institut Bergonie; Isabelle Ray-Coquard, Centre Leon Berard; Jean-Pierre Crumbach, Centre Hospitalier Freyming Merlebach Cedex; Philippe Agape, Tawfiq Henni, Tahar Touahri and Jean-Francois Paitel, Centre Hospitalier Felix Guyon - Allée Des Topazes; Valérie Moulin, Aurélie Ferru, Patrick Bouchaert, Chu La Miletrie; Dominique Spaeth, Fabien Brocard and Célia Becuwe, Centre D'oncologie De Gentilly; Fabienne Watelle, Centre Hospitalier Dr Schaffner; Nadine Paillot, Caroline Cuvier, Marjorie Lallom and Sylvie Giacchotti, Hopital De Mercy; Sandrine Richard and Julie Gachet, Hopital Europeen Georges Pompidou; Marielle Guillet, Jean-Christophe Souquet and Lionel Wander, Hopital Croix Rousse; Marc Espie, Florence Coussy, Sylvie Giacchetti, Caroline Cuvier and Marjorie Lallom, Hopital Saint Louis; Karima Yakendji Bekredda, Polyclinique Sainte Marguerite; Laurent Bastit, Clinique Pasteur; Alain Saad, Selva David and Tony Nakry, Centre Hospitalier Beziers Cedex; Elisabeth Perez and Patricia Zunic, Groupe Hospitalier Sud Reunion; Jean-Philippe Metges, Institut De Cancérologie Et D'hématologie - Hôpital Morvan; Hugues Bourgeois, Clinique Victor Hugo; Philippe Laplaige, Polyclinique De Blois; Nathalie Denizon, Centre Hospitalier Le Mans Cedex 9; Michaël Finaud, Djamal Hadjadj Aoul, Velardocchio, Clinique Vert Coteau; Alain Ducolone and Elisabeth Quoix, Nouvel Hopital Civil; Jean-Pierre Lotz, Hopital Tenon; Anne Mercier-Blas and Xavier Artignan, Centre Hospitalier Prive Saint Gregoire; Jean-Louis Lacaze and Audrey Eche, Institut Claudius Regaud; and Olivier Romano, Hopital Prive La Louviere.

Conflict of interest

Alain Toledano, Elisabeth Luporsi, Kamel Laribi, Jérôme Barrière, Philippe Huot-Marchand and Roland Bugat reported no conflict of interest. Florian Scotté is consultant to Vifor Pharma. Jean François Morere received funding from Vifor Pharma. Ladan Duvillié and Victor Hugo Concas are employees of Vifor Pharma France. The authors are fully responsible for content and editorial decisions for this paper. All authors had access to the primary study data. All authors reviewed the paper and approved the final version.

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Authors and Affiliations

  1. American Hospital of Paris, 63, Bd Victor Hugo, 92200, Neuilly-sur-Seine, France

    Alain Toledano

  2. Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France

    Elisabeth Luporsi

  3. Hôpital Avicenne, Bobigny, France

    Jean François Morere

  4. Hôpital Européen Georges-Pompidou, Paris, France

    Florian Scotté

  5. Centre Hospitalier Le Mans Cedex 9, Le Mans, France

    Kamel Laribi

  6. Centre Antoine Lacassagne, Nice, France

    Jérôme Barrière

  7. ICTA, Fontaine-les-Dijon, France

    Philippe Huot-Marchand

  8. Vifor Pharma, Neuilly-sur-Seine Cedex, France

    Ladan Duvillié & Victor Hugo Concas

  9. Institut Claudius Regaud, Toulouse, France

    Roland Bugat

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  1. Alain Toledano
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  2. Elisabeth Luporsi
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  9. Victor Hugo Concas
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  10. Roland Bugat
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Correspondence to Alain Toledano.

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Toledano, A., Luporsi, E., Morere, J.F. et al. Clinical use of ferric carboxymaltose in patients with solid tumours or haematological malignancies in France. Support Care Cancer 24, 67–75 (2016). https://doi.org/10.1007/s00520-015-2728-3

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  • DOI: https://doi.org/10.1007/s00520-015-2728-3

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