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.
Study design: We conducted a retrospective observational study that included patients with recurrent malignant glioma who where treated with temozolomide.
Patients and 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.
Main outcome measures and 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.