Low-dose fotemustine for recurrent malignant glioma: a multicenter phase II study

摘要: Fotemustine at the conventional dose of 100 mg/m2 is an active treatment for recurrent malignant gliomas (RMGs). However, it associated with a relevant incidence severe myelotoxicity, which not justified in palliative setting this disease. This study was conducted to address whether administration fotemustine 60 mg/m2 (induction) followed by 75 mg/m2 (maintenance) would preserve clinical activity advantage improved tolerance. Forty patients RMGs pretreated ≤2 lines chemotherapy were enrolled. Median age 57 years (26–80) and median Karnofsky performance status 80 (60–100). Thirty-one (77.5%) had tissue available analysis O6-methylguanine methyltransferase (MGMT) gene promoter found be methylated 14 cases (45%). Overall, 8 partial responses (20%) 13 disease stabilizations (32.5%) observed disease-control rate 52.5%. At 6 months, 21% free from progression. Grades 3 4 platelet white blood cell toxicity occurred ≤10% patients, no discontinued because toxicity. No significant difference control between unmethylated although trend toward progression-free survival reported patients. Low-dose has comparable that full-dose regimen, therefore should preferred its greater tolerability. The role MGMT methylation relation sensitivity still unclear needs further evaluation future trials.