Survival of patients with recurrent malignant glioma treated with temozolomide: a retrospective observational study.
OBJECTIVE
To assess whether the survival of patients with recurrent malignant glioma receiving temozolomide in everyday practice is comparable to that reported in previous studies.


METHODS
We conducted a retrospective observational study that included patients with recurrent malignant glioma who where treated with temozolomide.


METHODS
The study was based on prospective clinical databases managed by the Italian Local Health Units; the databases are required by Italian Law 648/96 for patients treated with temozolomide before drug approval by the reimbursement agency of the Italian Ministry of Health.


RESULTS
201 patients who had received temozolomide during the qualifying period of Law 648/96 for this drug (from 11 March 1998 to 30 September 2000) were included in our study. The clinical indications for temozolomide were glioblastoma multiforme (n = 123), anaplastic astrocytoma (n = 49) or other indications (n = 28). One patient did not have an indication reported. The median survival for patients with glioblastoma multi-forme and anaplastic astrocytoma was 13 and 20.3 months, respectively (with survival rates at 6 months of 81% and 78%, respectively). In our group of 49 patients with anaplastic astrocytoma, the survival plateau observed between 22 and 37 months (with no fatalities over this long time interval) suggested a favourable outcome, although restricted to a small subgroup. The 123 patients with glioblastoma multiforme showed a slightly better survival than that reported previously, but all patients died before 32 months.


CONCLUSIONS
This observational study extends the previous information regarding the efficacy of temozolomide and provides survival data from patients treated in everyday practice.
Trippoli
Sabrina
S
Laboratorio SIFO di Farmacoeconomia, Drug Information Centre, Azienda Ospedaliera Careggi, Florence, Italy. md3439@mclink.it
Pelagotti
Filippo
F
Messori
Andrea
A
Vacca
Franca
F
Vaiani
Monica
M
Maltoni
Susanna
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001254:Astrocytoma / Q000188:drug therapy / Q000401:mortality; D016543:Central Nervous System Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002986:Clinical Trials as Topic; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy / Q000401:mortality; D005910:Glioma / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D009837:Oligodendroglioma / Q000188:drug therapy; D012189:Retrospective Studies; D016019:Survival Analysis; D000077204:Temozolomide; D013997:Time Factors; D016896:Treatment Outcome
D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide