Phase II Evaluation of Temozolomide and 13-cis-Retinoic Acid for the Treatment of Recurrent and Progressive Malignant Glioma: A North American Brain Tumor Consortium Study.
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Website: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12805331&dopt=Abstract
Posted on: 06/16/2003
J Clin Oncol. 2003 Jun 15;21(12):2305-11.
Phase II Evaluation of Temozolomide and 13-cis-Retinoic Acid for the Treatment of Recurrent and Progressive Malignant Glioma: A North American Brain Tumor Consortium Study.
Jaeckle KA, Hess KR, Yung WK, Greenberg H, Fine H, Schiff D, Pollack IF, Kuhn J,
Fink K, Mehta M, Cloughesy T, Nicholas MK, Chang S, Prados M.
Department of Oncology and Neurology, Mayo Clinic Jacksonville, 4500 San Pablo
Blvd, Jacksonville, FL 32224; jaeckle.kurt@mayo.edu.
PURPOSE: Temozolomide (TMZ) and 13-cis-retinoic acid (cRA) have shown activity
in prior single-agent trials of recurrent malignant gliomas (MG). This phase II
trial evaluated efficacy and toxicity of combination temozolomide and cRA
treatment in recurrent MG. PATIENTS AND METHODS: Adults with recurrent
supratentorial MG for whom surgery, radiation, and/or chemotherapy failed were
eligible. Treatment included oral TMZ 150 or 200 mg/m2/d, days 1 through 5, and
cRA 100 mg/m2/d, days 1 to 21, every 28 days. Primary end point was
progression-free survival at 6 months (PFS 6); secondary end points included
response, survival, and PFS12. RESULTS: Eighty-eight eligible patients
(glioblastoma multiforme [n = 40]; anaplastic gliomas [n = 48; astrocytoma, 28;
oligodendroglioma, 14; mixed glioma, six]) received treatment. PFS 6 was 43%
(95% confidence interval [CI], 33% to 54%) and PFS12 was 16% (95% CI, 10% to
26%). Median overall PFS was 19 weeks (95% CI, 16 to 27 weeks), and median
overall survival (OS) was 47 weeks (95% CI, 36 to 58 weeks). OS was 46% (95% CI,
36% to 57%) at 52 weeks and 21% (95% CI, 13% to 31%) at 104 weeks. Of 84
assessable patients, there were two (3%) complete responses and eight (12%)
partial responses (complete plus partial response, 15%). Among 499 treatment
cycles, the most common grade 3/4 events included granulocytopenia (1.8%),
thrombocytopenia (1.4%), and hypertriglyceridemia (1.2%). CONCLUSION: TMZ and
cRA were active, exceeding our 20% thresholds for PFS 6 success, assuming 20%
improvement over our previously reported database (glioblastoma multiforme:
expected, 30%; observed, 32%; anaplastic glioma: expected, 40%; observed, 50%).
PMID: 12805331 [PubMed - in process]
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