title: Temozolomide as first-line agent in treating high-grade gliomas: phase II study.
abstract: Temozolomide a recent, oral, second generation alkylating agent is a chemotherapeutic with demonstrated efficacy for the treatment of high-grade gliomas; its efficacy has been demonstrated in both pre-clinical and phase I and II studies. The goal of this study is to determine the activity and safety of temozolomide in improving overall survival (OS), progression-free survival (PFS) and health-related quality of life (HQL) in patient with malignant gliomas. Forty-two patients with newly diagnosed glioblastoma, anaplastic astrocytoma and anaplastic oligodendroglioma were studied. The mean follow-up period was 12 months. The overall response rate (only responsive patient) for all histological groups was 40%, 10 patients (24%) showed a stabilization of disease. The median PFS and OS was respectively 8.35 and 14.1 months: time to progression was 34 week ranging from 21 to 47. In all patients, treatment with temozolomide was associated with improvement of performance status including the patient showing disease progression: Karnofski score improved in all patients by a minimum of 10, with a median of 20 at 6 months. No patient stopped the treatment due to side-effects, no major adverse events were recorded.
  
  
  CONCLUSIONS
  Temozolomide appears to be an ideal, first-line, single-agent, with a safe profile and demonstrated HQL benefits in patients with high-grade gliomas.
authors.affiliation: Department of Neurosurgery, Livorno Hospital, Italy. schibbaro@hotmail.com
authors.forename: S
authors.initials: S
authors.lastname: Chibbaro
authors.forename: L
authors.initials: L
authors.lastname: Benvenuti
authors.forename: A
authors.initials: A
authors.lastname: Caprio
authors.forename: S
authors.initials: S
authors.lastname: Carnesecchi
authors.forename: F
authors.initials: F
authors.lastname: Pulerà
authors.forename: F
authors.initials: F
authors.lastname: Faggionato
authors.forename: D
authors.initials: D
authors.lastname: Serino
authors.forename: C
authors.initials: C
authors.lastname: Galli
authors.forename: M
authors.initials: M
authors.lastname: Andreuccetti
authors.forename: N
authors.initials: N
authors.lastname: Buxton
authors.forename: R
authors.initials: R
authors.lastname: Gagliardi
mesh_terms: D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005910:Glioma / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide