Temozolomide and anaplastic astrocytoma: new indication. No clear proof of efficacy

(1) Temozolomide, a cytotoxic agent, was recently licensed in France for treating patients with anaplastic astrocytoma who are in relapse or progression after standard therapy. (2) The clinical dossier contains only one non comparative trial. (3) In this trial, 111 patients with anaplastic astrocytoma or oligoanaplastic astrocytoma had not all had the standard treatment with surgery, radiotherapy and chemotherapy based on nitrosourea plus procarbazine. In the subgroup of 54 patients who met these criteria, median global survival on temozolomide was 16 months, or 31 months from the start of initial treatment, which was no better than survival before the introduction of temozolomide. (4) The adverse effects of temozolomide include gastrointestinal disorders (nausea, vomiting, constipation), headache, and haematological disorders.