Article
Centre dependent variations in surgery for malignant gliomas and their impact on outcome in the phase III 5-ALA study
Zentrumsabhängige Variation im Grad der Resektion maligner Gliome in der Phase-III-ALA-Studie und ihr Einfluss auf Tumorprogression und Überleben
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Authors
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W. Stummer
- Neurochirurgische Klinik, Heinrich-Heine Universität Düsseldorf
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U. Pichlmeier
- MedacGesellschaft für medizinische Spezialpräparate mbH, Hamburg
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T. Meinel
- MedacGesellschaft für medizinische Spezialpräparate mbH, Düsseldorf
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O.D. Wiestler, die ALA-Glioma Studie Gruppe
- Institut für Neuropathologie, Universitätsklinikum Bonn
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F.E. Zanella
- Institut für Neuroradiologie, Klinikum der J.-W. Goethe Universität Frankfurt
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H.J. Reulen
- Ludwig-Maximilians-Universität München
| Published: | May 8, 2006 |
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Outline
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Objective: The phase III study on fluorescence-guided resection of malignant gliomas using 5-ALA disclosed marked variations in the rates of resections achieved in individual centres. The present analysis was designed to assess the reasons for the observed variability and its impact on the outcome of patients.
Methods: A number of factors with possible influence on the surgeon’s decision to resect gliomas more or less completely were identified in the data bank of the phase III study, that is, the use of 5-ALA, patient age, midline shift, Karnofsky Performance Status (KPS), affected hemisphere, tumor proximity to the ventricle, eloquent location and study centre. To further analyze the impact of differences in the rate of resections, centres were subdivided into centres with large differences in the rate of resections between ALA and white light (WL) patients („strong implementation“) and small differences between ALA and WL patients („moderate implementation“). Resulting patient groups were compared regarding their prognostic characteristic age, KPS, and histology. Progression free survival (PFS), post-operative KPS and overall survival (OS) were calculated for patients in the respective centres.
Results: Age, the use of 5-ALA, proximity to the ventricles, and eloquent location were independently associated with the completeness of resection. In addition, there was a strong and independent influence of the centre. Patients from centres with “strong“ and moderate“ implementation were comparable regarding their prognostic factors. No significant differences were observed with respect to PFS (3.6 vs. 3.6 months) and OS (13.9 vs. 11.7 months) comparing ALA and WL patients in centres with „moderate“ implementation. In centres with "strong" implementation, PFS and OS were significantly increased in ALA patients (5.1 vs. 3.5 months and 12.8 vs. 17.6 months, respectively, p<0.001 each). “Strong” implementation did not adversely affect KPS.
Conclusions: This analysis demonstrates strong center dependent influences on the degree of resection of malignant gliomas in the ALA study. Stratification by centres with “moderate” or “strong” implementation clearly underlines the importance of complete resections for outcome and the usefulness of 5-ALA as a diagnostic tool for achieving this aim.
