|
|
Multicenter phase II trial of temozolomide in patients with anaplastic
astrocytoma or anaplastic oligoastrocytoma at first relapse. Temodal Brain Tumor
Group
Yung WK, Prados MD, Yaya-Tur R, Rosenfeld SS, Brada M, Friedman HS, Albright
R, Olson J, Chang SM, O'Neill AM, Friedman AH, Bruner J, Yue N, Dugan M, Zaknoen
S, Levin VA.
University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
yung@manderson.org
Purpose. To determine the antitumor efficacy and safety profile of temozolomide
in patients with malignant astrocytoma at first relapse.
Patients and Methods.
This open-label, multicenter, phase II trial enrolled 162 patients
(intent-to-treat [ITT] population).
After central histologic review, 111
patients were confirmed to have had an anaplastic astrocytoma (AA) or anaplastic
mixed oligoastrocytoma.
Chemotherapy-naive patients were treated with
temozolomide 200 mg/m(2)/d.
Patients previously treated with chemotherapy
received temozolomide 150 mg/m(2)/d; the dose could be increased to 200
mg/m(2)/d in the absence of grade 3/4 toxicity.
Therapy was administered orally
on the first 5 days of a 28-day cycle.
Results. Progression-free survival (PFS)
at 6 months, the primary protocol end point, was 46% (95% confidence interval,
38% to 54%).
The median PFS was 5.4 months, and PFS at 12 months was 24%.
The
median overall survival was 13.6 months, and the 6- and 12-month survival rates
were 75% and 56%, respectively.
The objective response rate determined by
independent central review of gadolinium-enhanced magnetic resonance imaging
scans of the ITT population was 35% (8% complete response [CR], 27% partial
response [PR]), with an additional 26% of patients with stable disease (SD).
The
median PFS for patients with SD was 4.4 months, with 33% progression-free at 6
months.
Maintenance of progression-free status and objectively assessed response
(CR/PR/SD) were both associated with health-related quality-of-life (HQL)
benefits.
Adverse events were mild to moderate, with hematologic side effects
occurring in less than 10% of patients.
Conclusion. Temozolomide demonstrated
good single-agent activity, an acceptable safety profile, and documented HQL
benefits in patients with recurrent AA.
PMID: 10561351 [PubMed - indexed for
MEDLINE]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10561351&dopt=Abstract
|
