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Implantation of carmustine wafers (Gliadel®) for high-grade glioma treatment. A 9-year nationwide retrospective study

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Abstract

Background

Carmustine wafers (CW) are approved to treat newly or recurrent high-grade gliomas (HGG). Widespread use has been limited regarding some doubtful uncertainties about their efficacy, related increased risk of infection and expensive cost.

Objective

To describe the epidemiology of CW implantation, search for related complications, long-term survival and associated prognostic factors.

Methods

We processed the French medico-administrative national database to retrieve appropriate cases operated between 2010 and 2018. A survival analysis was conducted.

Results

We identified 1659 patients treated in 39 institutions. Median age at CW implantation was 61 years and there was an over-representation of male (63.5%). 491 patients (29.6%) had previous diagnosis of glioma. Time between the first surgery and CW implantation was 0.9 years, IQR[0.6, 1.6]. The frontal lobe was the most frequently involved 29%. 131 patients (7.9%) had to be re operated on for a complication of which 121 for surgical site infection. At one year, 514 patients (31%) had died. Median overall survival (OS) was 1.4 years, 95% CI [1.3, 1.5]. OS at 1 and 2 year was 66%, 95%CI [63.7, 68.5], 32.3%, 95%CI [29.9, 35]. In the adjusted Cox regression, male gender & age at CW implantation were established as independent factors of OS in all three groups. Patients with recurrent HGG have a significant worse prognosis (HR = 0.71, 95% CI [0.62, 0.80] p < 0.001). A post-operative diagnosis of infection or intracranial bleeding eventually leading to a redo surgery was not associated with a decrease OS.

Conclusion

Over the past 9 years, there is a significant decrease utilisation of CW in France. OS after CW implantation is significantly variable as influenced by many factors such as age, gender or recurrent disease but not by post-operative complications. Compare to previous results, CW may increase the OS and this effect seems more pronounced when adjuvant RT/TMZ is given.

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Abbreviations

CCAM:

Common classification of medical acts

CI:

Confidence interval

CSF:

Cerebro spinal fluid

HR:

Hazard ratio

HGG:

High grade glioma

IQR:

Inter quartile range

LGG:

Low grade glioma

MGMT:

Methyl guanine methyl transferase

NA:

Not applicable or not available

NS:

Not significant

PMSI:

Programme de Médicalisation des Systèmes d’Information

OS:

Overall survival

RT:

Radiotherapy

TMZ:

Temozolomide

RT/TMZ:

Concomitant radio-chemotherapy according the Stupp protocol

WHO:

World Health Organization

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Acknowledgements

We thank the ATIH for its assistance and Miss Rebecca Grant for her review of the manuscript.

Funding

This research received no grant from any funding agency in the public, commercial, or not-for-profit sectors.

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Author notes

  1. Charles Champeaux and Joconde Weller contributed equally to this work.

Authors and Affiliations

  1. INSERM U1153, Statistic and Epidemiologic Research Centre Sorbonne Paris Cité (CRESS), ECSTRA Team, Université Diderot - Paris 7, USPC, Paris, France

    Charles Champeaux

  2. Department of Neurosurgery, Lariboisière Hospital, 75010, Paris, France

    Charles Champeaux

  3. Agence régionale de santé, 2bis, Avenue Georges Brassens, CS 61002 - 97743, Saint Denis Cedex 9, France

    Joconde Weller

Authors
  1. Charles Champeaux
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Contributions

CC: Conceived and designed the analysis/Collected the data/Performed the analysis/Wrote the paper/Revision of the work, JW: Conceived and designed the analysis/Collected the data/Revision of the work/Final approval.

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Correspondence to Charles Champeaux.

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Champeaux, C., Weller, J. Implantation of carmustine wafers (Gliadel®) for high-grade glioma treatment. A 9-year nationwide retrospective study. J Neurooncol 147, 159–169 (2020). https://doi.org/10.1007/s11060-020-03410-1

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