Abstract | PURPOSE: PATIENTS AND METHODS: Forty-four patients with recurrent GBM after standard radiotherapy were enrolled. For 19 patients, this therapy was their first chemotherapy after tumor progression after irradiation; 25 others had received chemotherapy previously. TMZ 150 to 200 mg/m(2) days 1 to 5 and MRM 50 mg days 8 to 28 was administered at 28-day intervals for two cycles; then patients were reevaluated. Treatment continued until progression of tumor or toxicity developed. RESULTS: Joint and tendon pain was the major therapy-related toxicity and was reported in 47% of patients. Five patients (11%) were removed from the study because of intolerable joint pain. For all patients, the progression-free survival (PFS) at 6 months was 39%. Median PFS was 17 weeks, median overall survival was 45 weeks, and 12-month PFS was 16%. CONCLUSION: The combination of TMZ and MRM resulted in a PFS at 6 months that exceeded the literature target by 29%. This drug combination met phase II study criteria; further study in recurrent patients with GBM might be warranted. Further study of therapy-induced joint pain is necessary.
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Authors | Morris D Groves, Vinay K Puduvalli, Kenneth R Hess, Kurt A Jaeckle, Pamela Peterson, W K Alfred Yung, Victor A Levin |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 20
Issue 5
Pg. 1383-8
(Mar 01 2002)
ISSN: 0732-183X [Print] United States |
PMID | 11870183
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Antineoplastic Agents, Alkylating
- Enzyme Inhibitors
- Hydroxamic Acids
- Dacarbazine
- marimastat
- Temozolomide
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Topics |
- Adult
- Aged
- Antineoplastic Agents, Alkylating
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Brain Neoplasms
(drug therapy)
- Dacarbazine
(administration & dosage, analogs & derivatives)
- Disease-Free Survival
- Drug Administration Schedule
- Enzyme Inhibitors
(administration & dosage)
- Female
- Glioblastoma
(drug therapy)
- Humans
- Hydroxamic Acids
(administration & dosage)
- Male
- Middle Aged
- Neoplasm Recurrence, Local
- Temozolomide
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