A phase II study of extended low-dose temozolomide in recurrent malignant gliomas Journal Article
| Authors: | Khan, R. B.; Raizer, J. J.; Malkin, M. G.; Bazylewicz, K. A.; Abrey, L. E. |
| Article Title: | A phase II study of extended low-dose temozolomide in recurrent malignant gliomas |
| Abstract: | Temozolomide is an effective agent in the treatment of recurrent malignant gliomas. The standard dosage is 150-200 mg/m2 per day for 5 days in a 28-day cycle. A prior phase I study established a chronic daily temozolomide dose that significantly increased the total dose administered and suggested a superior response rate. In a prospective phase II trial, we treated 35 patients with recurrent malignant gliomas with temozolomide 75 mg/m2 per day for 42 consecutive days in a 70-day cycle. Median age was 55 years (range, 27-73 years) and median Karnofsky performance score was 70 (range, 60-90). Twenty-eight (79%) patients had glioblastoma multiforme, 3 (9%) anaplastic astrocytoma, 2 (6%) anaplastic oligodendroglioma, and 2 (6%) anaplastic oligoastrocytoma. All but one had prior radiotherapy, and 27 had prior chemotherapy. There were 2 partial (anaplastic astrocytoma) and 3 minor (glioblastoma multiforme) radiographic responses; 17 patients had progressive disease at the end of the first cycle. In 55 cycles of temozolomide, there were 8 episodes of asymptomatic drug-related grade 3 toxicity: 6 lymphopenia, 1 neutropenia, and 1 thrombocytopenia. Median progression-free survival and overall survival were 2.5 and 8.7 months (2.3 and 7.7 months in glioblastoma multiforme patients). At 6 months, progression-free survival and overall survival rates were 27% and 67% (19% and 60% in glioblastoma multiforme). Quality of life scores did not change significantly during treatment. We conclude that the extended low-dose schedule of temozolomide is well tolerated in heavily pretreated patients; however, our results do not support an improved rate of response or survival. |
| Keywords: | adult; clinical article; controlled study; treatment outcome; aged; middle aged; survival analysis; clinical trial; drug tolerability; neutropenia; cancer recurrence; dose response; drug efficacy; temozolomide; nuclear magnetic resonance imaging; glioma; brain neoplasms; prospective study; prospective studies; dacarbazine; quality of life; controlled clinical trial; liver toxicity; phase 2 clinical trial; neoplasm recurrence, local; thrombocytopenia; dose-response relationship, drug; carmustine; lymphocytopenia; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; gastrointestinal toxicity; survival time; glioblastoma; drug response; antineoplastic agents, alkylating; scoring system; oligodendroglioma; astrocytoma; anaplastic carcinoma; nitrosourea derivative; humans; prognosis; human; male; female; article |
| Journal Title: | Neuro-Oncology |
| Volume: | 4 |
| Issue: | 1 |
| ISSN: | 1522-8517 |
| Publisher: | Oxford University Press |
| Date Published: | 2002-01-01 |
| Start Page: | 39 |
| End Page: | 43 |
| Language: | English |
| DOI: | 10.1215/s1522851701000382 |
| PUBMED: | 11772431 |
| PROVIDER: | scopus |
| PMCID: | PMC1920633 |
| DOI/URL: | |
| Notes: | Presented as a poster at the 37th Annual Meeting of the American Society of Clinical Oncology; 2001 May 12-15; San Francisco, CA -- Export Date: 14 November 2014 -- Source: Scopus |
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