Seth A Climans1, Alba A Brandes2, J Gregory Cairncross3, Keyue Ding4, Michael Fay5,6, Normand Laperriere7,8, Johan Menten9, Ryo Nishikawa10, Christopher J O'Callaghan4, James R Perry11, Claire Phillips12, Wilson Roa13, Wolfgang Wick14, Chad Winch4, Warren P Mason7. 1. Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada. seth.climans@uhn.com. 2. Azienda Unità Sanitaria Locale - Istituto di Ricovero e Cura a Carattere Scientifico Istituto delle Scienze Neurologiche, Bologna, Italy. 3. University of Calgary, Calgary, Canada. 4. The Canadian Cancer Trials Group, Queen's University, Kingston, Canada. 5. University of Newcastle, Newcastle, Australia. 6. University of Queensland, Brisbane, Australia. 7. Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada. 8. Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Canada. 9. University Hospital Gasthuisberg, Leuven, Belgium. 10. Saitama Medical University International Medical Center, Saitama, Japan. 11. Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada. 12. Peter MacCallum Cancer Centre, Melbourne, Australia. 13. University of Alberta, Edmonton, Canada. 14. Neurology Clinic, University of Heidelberg and Neurooncology Program, German Cancer Research Center, Heidelberg, Germany.
Abstract
INTRODUCTION: Tumor-related epilepsy may respond to chemotherapy. In a previously-published multi-centre randomized clinical trial of 562 elderly glioblastoma patients, temozolomide plus short-course radiotherapy conferred a survival benefit over radiotherapy alone. Seizure outcomes were not reported. METHODS: We performed an unplanned secondary analysis of this trial's data. The trial design has been previously reported. Seizures were recorded by clinicians as adverse events and by patients in quality of life questionnaires. A Chi-square test of seizure rates between the two groups (α = 0.05) and a Kaplan-Meier estimator of time-to-first self-reported seizure were planned. RESULTS: Almost all patients were followed until they died. In the radiotherapy alone group, 68 patients (24%) had a documented or self-reported seizure versus 83 patients (30%) in the temozolomide plus radiotherapy group, Chi-square analysis showed no difference (p = 0.15). Patients receiving radiotherapy alone tended to develop seizures earlier than those receiving temozolomide plus radiotherapy (p = 0.054). Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02). CONCLUSIONS: This study was not powered to detect differences in seizure outcomes, but temozolomide seemed to have minimal impact on seizure control in elderly patients with glioblastoma. CLINICAL TRIAL REGISTRATION: NCT00482677 2007-06-05.
RCT Entities:
INTRODUCTION: Tumor-related epilepsy may respond to chemotherapy. In a previously-published multi-centre randomized clinical trial of 562 elderly glioblastomapatients, temozolomide plus short-course radiotherapy conferred a survival benefit over radiotherapy alone. Seizure outcomes were not reported. METHODS: We performed an unplanned secondary analysis of this trial's data. The trial design has been previously reported. Seizures were recorded by clinicians as adverse events and by patients in quality of life questionnaires. A Chi-square test of seizure rates between the two groups (α = 0.05) and a Kaplan-Meier estimator of time-to-first self-reported seizure were planned. RESULTS: Almost all patients were followed until they died. In the radiotherapy alone group, 68 patients (24%) had a documented or self-reported seizure versus 83 patients (30%) in the temozolomide plus radiotherapy group, Chi-square analysis showed no difference (p = 0.15). Patients receiving radiotherapy alone tended to develop seizures earlier than those receiving temozolomide plus radiotherapy (p = 0.054). Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02). CONCLUSIONS: This study was not powered to detect differences in seizure outcomes, but temozolomide seemed to have minimal impact on seizure control in elderly patients with glioblastoma. CLINICAL TRIAL REGISTRATION: NCT00482677 2007-06-05.
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