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01-06-2011 | Clinical Study – Patient Study

Favorable outcome in the elderly cohort treated by concomitant temozolomide radiochemotherapy in a multicentric phase II safety study of 5-ALA

Authors: Walter Stummer, Ulf Nestler, Florian Stockhammer, Dietmar Krex, Bodo C. Kern, Hubert M. Mehdorn, Giles H. Vince, Uwe Pichlmeier

Published in: Journal of Neuro-Oncology | Issue 2/2011

Abstract

The primary objective of this augmental, prospective, uncontrolled phase II multicentre trial was to assess adverse events (AE) associated with malignant glioma resection using 5-aminolevulinic (5-ALA). During accrual, the standard of adjuvant therapy changed to concomitant radiochemotherapy with adjuvant temozolomide (RT/TMZ). Thus, this study also provided a platform for investigating the influence of RT/TMZ on survival in patients with fluorescence-guided resections. Malignant glioma patients, aged 18–75 years and with a Karnofsky performance score (KPS) ≥70%, were eligible. Data were collected on adverse events, KPS, survival and adjuvant therapies. In 243 patients evaluable for safety, 6-week AE incidence was 51.9% (nervous system disorders: 30.0%). Three patients experienced four possibly drug-related AEs. Grade III/IV incidence was 18.9% (nervous system disorders: 10.7%). About 48 h after surgery, AE incidence was 26.3% (9.9% grade III/IV), which was related to overall survival. A total of 219 patients (glioblastoma 206; anaplastic astrocytoma: 13) qualified for efficacy analysis. Median overall survival was 14.1 months (95% CI: 12.0–16.6), but 16.3 (13–19.2) months in 122 glioblastoma patients receiving RT/TMZ compared to 11.9 (9.6–14.1) months in the remaining 84 patients (P = 0.0194). Older patients (≥60 years) had less adjuvant therapies than younger patients. Median survival of older glioblastoma patients with RT/TMZ was also significantly prolonged (16.3; 12.0–17.2 months vs. 11.2; 7.4–14.1, hazard ratio = 0.55; 0.32–0.92). Risks of surgery were similar to past experiences with 5-ALA. Ancillary analyses demonstrated surgical glioblastoma patients, including the elderly, to have derived benefit from RT/TMZ. Thus, older patients should not generally be excluded from accepted therapies (fluorescence-guided resection plus RT/TMZ).

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Title: Favorable outcome in the elderly cohort treated by concomitant temozolomide radiochemotherapy in a multicentric phase II safety study of 5-ALA
Authors: Walter Stummer
Ulf Nestler
Florian Stockhammer
Dietmar Krex
Bodo C. Kern
Hubert M. Mehdorn
Giles H. Vince
Uwe Pichlmeier
Publication date: 01-06-2011
Publisher: Springer US
Published in: Journal of Neuro-Oncology / Issue 2/2011
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI: https://doi.org/10.1007/s11060-010-0400-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Favorable outcome in the elderly cohort treated by concomitant temozolomide radiochemotherapy in a multicentric phase II safety study of 5-ALA

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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