Randomized comparison of diaziquone and carmustine in the treatment of adults with anaplastic glioma
| Autor: | Edward C. Halperin, R. Morawetz, D R Macdonald, E J Dropcho, James E. Herndon, Darell D. Bigner, Nicholas A. Vick, S. C. Schold, J G Cairncross, Peter C. Burger |
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| Rok vydání: | 1993 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Prognostic variable medicine.medical_treatment Aziridines Brain tumor Antineoplastic Agents Central nervous system disease Internal medicine Benzoquinones medicine Humans Proportional Hazards Models Analysis of Variance Chemotherapy Carmustine Diaziquone Brain Neoplasms business.industry Glioma Middle Aged medicine.disease Combined Modality Therapy Survival Analysis Surgery Radiation therapy Tumor progression Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 11:77-83 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | PURPOSE We conducted a phase III trial comparing intravenous (IV) diaziquone (AZQ) and carmustine (BCNU) as single agents in patients with cerebral anaplastic gliomas who had received surgery and radiotherapy. Its purpose was to compare the efficacy of AZQ with that of BCNU, the standard agent for brain tumor chemotherapy. PATIENTS AND METHODS Randomization between the two regimens occurred 8 weeks after completion of radiotherapy. A total of 251 patients were randomized to receive either AZQ or BCNU, and there were no significant differences between the two treatment arms in any of the known prognostic variables, including age, histologic grade, and Karnofsky performance status (KPS). RESULTS There was no significant difference in either time to tumor progression or survival between the two treatment arms. Age and histology were strong predictors of outcome, whereas KPS had relatively less effect. Three groups of patients with distinctly different outcomes could be identified: (1) older age (45+) and glioblastoma/gliosarcoma (GBM/GS) patients had a median survival of 37 weeks after randomization; (2) patients with either older age or GBM/GS had a median survival of 61 weeks; and (3) younger age (< 45) and non-GBM/GS (usually anaplastic astrocytoma) patients had a median survival of 147 weeks. Toxicity was primarily hematologic, although acute gastrointestinal toxicity and chronic pulmonary toxicity were more common with BCNU. Patients randomized to AZQ who had significant hematologic toxicity that required dose reduction after the first treatment cycle had significantly longer time to tumor progression and survival than those who did not require dose reduction (P = .011 and .016, respectively). CONCLUSION There was no significant difference in efficacy between AZQ and BCNU in patients with anaplastic gliomas as tested in this study, although AZQ was somewhat better tolerated. |
| Databáze: | OpenAIRE |
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