CONTRIBUTION OF FOTEMUSTINE IN THE TREATMENT OF PRIMARY BRAIN-TUMORS - CLINICAL OVERVIEW

In phase II clinical trials involving 241 adult patients, fotemustine used alone or in combination with other cytotoxic drugs and/or radiati on therapy has shown overall response rates of 36% for primary brain g liomas and 30% for recurrent high grade malignant brain gliomas, with respective overall median survivals of 40 and 31 weeks. The main toxic ity has been hematological in both patient populations, with leukopeni a in similar to 50% of patients (grade III-IV, 12-25%) and thrombocyto penia in similar to 60% (grade III-IV, 19-27%) at standard doses of 10 0 mg/m(2) i.v. weekly for 3 weeks followed by 100 mg/m(2) i.v. monthly after a 5-week resting period. Different assessment methods, low numb er of patients and no stratification according to prognostic factors m ake it difficult to define the role of fotemustine in the treatment of malignant brain tumors in adults. This is also applicable to other co mpounds. Other considerations such as neurological improvement, qualit y of life analysis and stratification according to histological type w ill define the activity of fotemustine in the future.