|
|
Phase II study of temozolomide without
radiotherapy in newly diagnosed glioblastoma multiforme in an elderly
populations
Chinot OL, Barrie M, Frauger E, Dufour H, Figarella-Branger D, Palmari J,
Braguer D, Hoang-Xuan K, Moktari K, Peragut JC, Martin PM,
Grisoli F
Service de Neurochirurgie, CHU Timone, Marseille, France.
olivier.chinot@ap-hm.fr
Background. Currently, the survival of patients age > 70 years
with glioblastoma multiforme (GBM) ranges from 4 months to 6 months, although
radiotherapy and/or chemotherapy may prolong survival in certain
subgroups.
Temozolomide is an oral chemotherapeutic agent with efficacy against malignant
gliomas and a favorable safety profile.
This open-label, single-center, Phase II study was designed to evaluate the
efficacy and safety of temozolomide as first-line chemotherapy and exclusive
treatment in elderly patients with newly diagnosed GBM.
Methods. Chemotherapy-naive patients (age > 70 years) were
treated with temozolomide at a dose of 150-200 mg/m(2) per day for 5 consecutive
days of a 28-day cycle until they developed disease progression.
No radiation therapy was administered.
The primary endpoint was median overall survival (OS); secondary endpoints
included progression-free survival (PFS) and toxicity.
Results. Thirty-two patients (median age, 75 years; median Karnofsky
performance status, 70) experienced a median OS of 6.4 months and a median PFS
of 5.0 months.
Of 29 patients who were assessed for response, 9 patients (31%) achieved a
partial response, 12 patients (41%) maintained stable disease, and 8 patients
(28%) developed progressive disease.
Adverse events primarily were mild, with NCI CTC Grade 3-4 thrombocytopenia and
neutropenia reported to occur in 6% and 9% of patients, respectively.
No neurotoxicity was observed.
Treatment delays and dose reductions occurred in 13% and 14% of cycles,
respectively.
Conclusions. Temozolomide represents a safe, easily administered,
and effective therapeutic approach for elderly patients with newly diagnosed
GBM.
Copyright 2004 American Cancer Society.
PMID: 15139066 [PubMed - indexed for MEDLINE]
Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15139066
|
