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Biodegradable Carmustine Wafers (Gliadel) Alone or in Combination with Chemoradiotherapy: The French Experience

  • Neuro-Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Carmustine-releasing wafers (Gliadel®) have been available and reimbursed in France since 2005.

Methods

A retrospective multicenter study was conducted in 26 French Departments of Neurosurgery to analyze practices of French neurosurgeons using Gliadel, compare the adverse effects and survival with those of previous phase III trials, and assess survival in patients with newly diagnosed malignant gliomas (MG) receiving Gliadel plus radiochemotherapy with temozolomide (TMZ). A total of 163 patients who received Gliadel for MG were included in this study: 83 (51%) with newly diagnosed MG and 80 (49%) with recurrent MG. In the newly diagnosed group, 51.8% of patients received radiochemotherapy with TMZ.

Results

Adverse events (AEs) emerged in 44.6% of the population, including 6% with septic abscess. The AE rate was not statistically correlated with adjuvant use of TMZ. For the newly diagnosed group, median survival was 17 months. Total or subtotal resection appeared to have a great impact on survival (P = 0.016), as did treatment with adjuvant radiotherapy (P = 0.004).

For the group with recurrent MG, median survival was 7 months. Total or subtotal resection excision appeared to have a great impact on survival (P = 0.002), as did preoperative Karnowsky Scale (PO-KPS) (P = 0.012).

Conclusions

Survival rates for newly diagnosed patients were better than those reported in previous phase III trials. The combination of Gliadel and radiochemotherapy with TMZ was well tolerated and appeared to increase survival without increasing AEs.

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Acknowledgment

We would like to thank the neurosurgeons, radiotherapists, oncologists, radiologists, and nurses who participated to this study and provided patient care. We thank also belongs to the authors Karim P. Moubarak MD for editorial assistance. Special thanks to: P Toussaint (Amiens); GA Czorny, J Godard, H Katranji (Besançon); T Faillot, M Kalamarides, G Iakolev (Beaujon-Paris); T Riem, A Rougier, P Monteil, G Penchet, JR Vigne, D Loguoro (Bordeaux); E Emery, JM Derlon, R Gadan, E. Lechapt-Zalcman (Caen); R Giacomelli, A. Monjour, B. Stilhart (Colmar); D Hoffmann (Grenoble); A Desplat (Pau), X Morandi, A Hamlat, L Riffaud, G Brassier (Rennes); O Langlois, F. Proust (Rouen); R Duthel (St Etienne); P François (Tours); M Gigaud, M Tremoulet (Toulouse); L Bauchet (Montpellier); C Pinelli (Nancy); K Moubarak, P Decq, and JP NGuyen (Paris-Henri Mondor).

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Authors and Affiliations

  1. Département de Neurochirurgie, INSERM U646, CHU d’Angers, Angers, France

    Philippe Menei MD, PhD

  2. Service de Neurochirurgie, Hôpital de la Timone, Marseille, France

    Philippe Metellus MD, PhD

  3. Centre de Recherche Clinique, CHU d’Angers, Angers, France

    Elsa Parot-Schinkel MD

  4. Clinique Universitaire de Neurochirurgie, Hôpital Pellegrin Tripode, Bordeaux, France

    Hugues Loiseau MD, PhD

  5. Service de Neurochirurgie, Hôpital Pitié Salpétrière, Paris, France

    Laurent Capelle MD

  6. Service de Neurochirurgie, Hôpital Jean Minjoz, Besançon, France

    Guy Jacquet MD

  7. Service de Neurochirurgie, Hôpital Neurologique Pierre Wertheimer, Lyon, France

    Jacques Guyotat MD

Authors
  1. Philippe Menei MD, PhD
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  2. Philippe Metellus MD, PhD
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  3. Elsa Parot-Schinkel MD
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  4. Hugues Loiseau MD, PhD
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  5. Laurent Capelle MD
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  6. Guy Jacquet MD
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  7. Jacques Guyotat MD
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The Neuro-oncology Club of the French Society of Neurosurgery

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Correspondence to Philippe Menei MD, PhD.

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Menei, P., Metellus, P., Parot-Schinkel, E. et al. Biodegradable Carmustine Wafers (Gliadel) Alone or in Combination with Chemoradiotherapy: The French Experience. Ann Surg Oncol 17, 1740–1746 (2010). https://doi.org/10.1245/s10434-010-1081-5

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  • DOI: https://doi.org/10.1245/s10434-010-1081-5

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