PMID- 10561351
OWN - NLM
STAT- MEDLINE
DCOM- 20000105
LR  - 20220316
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 17
IP  - 9
DP  - 1999 Sep
TI  - Multicenter phase II trial of temozolomide in patients with anaplastic 
      astrocytoma or anaplastic oligoastrocytoma at first relapse. Temodal Brain Tumor 
      Group.
PG  - 2762-71
AB  - 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.
FAU - Yung, W K
AU  - Yung WK
AD  - University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA. 
      yung@manderson.org
FAU - Prados, M D
AU  - Prados MD
FAU - Yaya-Tur, R
AU  - Yaya-Tur R
FAU - Rosenfeld, S S
AU  - Rosenfeld SS
FAU - Brada, M
AU  - Brada M
FAU - Friedman, H S
AU  - Friedman HS
FAU - Albright, R
AU  - Albright R
FAU - Olson, J
AU  - Olson J
FAU - Chang, S M
AU  - Chang SM
FAU - O'Neill, A M
AU  - O'Neill AM
FAU - Friedman, A H
AU  - Friedman AH
FAU - Bruner, J
AU  - Bruner J
FAU - Yue, N
AU  - Yue N
FAU - Dugan, M
AU  - Dugan M
FAU - Zaknoen, S
AU  - Zaknoen S
FAU - Levin, V A
AU  - Levin VA
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents, Alkylating)
RN  - 7GR28W0FJI (Dacarbazine)
RN  - YF1K15M17Y (Temozolomide)
SB  - IM
EIN - J Clin Oncol 1999 Nov;17(11):3693
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents, Alkylating/*therapeutic use
MH  - Astrocytoma/*drug therapy/pathology
MH  - Brain Neoplasms/*drug therapy/pathology
MH  - Dacarbazine/*analogs & derivatives/therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/*drug therapy/pathology
MH  - Prognosis
MH  - Proportional Hazards Models
MH  - Quality of Life
MH  - Survival Analysis
MH  - Temozolomide
EDAT- 1999/11/24 09:00
MHDA- 2000/03/04 09:00
CRDT- 1999/11/24 09:00
PHST- 1999/11/24 09:00 [pubmed]
PHST- 2000/03/04 09:00 [medline]
PHST- 1999/11/24 09:00 [entrez]
AID - 10.1200/JCO.1999.17.9.2762 [doi]
PST - ppublish
SO  - J Clin Oncol. 1999 Sep;17(9):2762-71. doi: 10.1200/JCO.1999.17.9.2762.