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Published in: Annals of Surgical Oncology 6/2013

01-06-2013 | Neuro-Oncology

Implanted Carmustine Wafers Followed by Concomitant Radiochemotherapy to Treat Newly Diagnosed Malignant Gliomas: Prospective, Observational, Multicenter Study on 92 Cases

Authors: Julien Duntze, MD, Claude-Fabien Litré, MD, PhD, Christophe Eap, MD, Etienne Théret, MD, Adeline Debreuve, Nicolas Jovenin, MD, Emmanuèle Lechapt-Zalcman, MD, PhD, Philippe Metellus, MD, PhD, Philippe Colin, MD, Jean-Sébastien Guillamo, MD, PhD, Evelyne Emery, MD, PhD, Philippe Menei, MD, PhD, Pascal Rousseaux, MD, Philippe Peruzzi, MD, PhD

Published in: Annals of Surgical Oncology | Issue 6/2013

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Abstract

Objectives

Study the feasibility and effectiveness of a treatment associated surgery, intraoperative chemotherapy (carmustine wafers), and concomitant radiochemotherapy (temozolomide) for the management of newly diagnosed, high-grade gliomas.

Methods

Prospective multicenter study conducted in 17 French centers with a total of 92 patients with newly diagnosed malignant glioma treated by surgery, implanted Carmustine wafers (Gliadel®) followed by concomitant radiochemotherapy by temozolomide (Temodar®). Clinical, imaging, and survival data were collected to study toxicity-induced adverse events and efficacy.

Results

A total of 20.6 % presented with adverse events during surgery, potentially attributable to carmustine, including 5 severe infections. Afterwards, 37.2 % of patients showed adverse events during radiochemotherapy and 40 % during adjuvant chemotherapy by temozolomide. We report a 10.5-month, median, progression-free survival and an 18.8-month median overall survival. No significant statistical difference was observed according to age, Karnofsky Performance Scale, or grade of the tumor. A prognostic difference at the limit of the significance threshold was observed according to the extent of the resection.

Conclusions

Multimodal treatment associating implanted carmustine chemotherapy and concomitant radiochemotherapy with temozolomide seems to yield better survival rates than those usually described when carmustine or temozolomide are used alone independently from one another. These interesting results were obtained without increased adverse events and would need to be validated during a phase 3 study.
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Metadata
Title
Implanted Carmustine Wafers Followed by Concomitant Radiochemotherapy to Treat Newly Diagnosed Malignant Gliomas: Prospective, Observational, Multicenter Study on 92 Cases
Authors
Julien Duntze, MD
Claude-Fabien Litré, MD, PhD
Christophe Eap, MD
Etienne Théret, MD
Adeline Debreuve
Nicolas Jovenin, MD
Emmanuèle Lechapt-Zalcman, MD, PhD
Philippe Metellus, MD, PhD
Philippe Colin, MD
Jean-Sébastien Guillamo, MD, PhD
Evelyne Emery, MD, PhD
Philippe Menei, MD, PhD
Pascal Rousseaux, MD
Philippe Peruzzi, MD, PhD
Publication date
01-06-2013
Publisher
Springer-Verlag
Published in
Annals of Surgical Oncology / Issue 6/2013
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-012-2764-x

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