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| |  Fotemustine Shows Activity as Single Agent in Recurrent or Progressive Gliomas: Presented at ENS By Judith Moser, MD NICE, France -- June 10, 2008 -- In patients with pretreated gliomas, anaplastic astrocytomas, and oligodendroglial tumours, fotemustine showed some activity as a second-, third-, or fourth-line of chemotherapy. Elisa Trevisan, MD, Division of Neuro-Oncology, Department of Neuroscience and Oncology, University and San Giovanni Battista Hospital, Torino, Italy, presented the study results here at the 18th Meeting of the European Neurological Society (ENS). Few data are available on the efficacy of fotemustine in malignant gliomas, according to Dr. Trevisan. Her research team therefore conducted their study to evaluate the efficacy and toxicity of chemotherapy after surgery and/or radiotherapy in patients with recurrent or progressive gliomas, she explained in an oral presentation on June 9. The trial included 110 patients with a median age of 52 years (range, 19-78 years), who had shown disease progression on magnetic resonance imaging (MRI) after previous treatments and displayed adequate bone-marrow reserve (thrombocytes >100,000/mL, leukocytes >3,500/mL, absolute neutrophil count >1,500m/L). The study was performed between September 2004 and December 2007. Patients with glioblastomas, anaplastic astrocytomas, anaplastic oligodendrogliomas, and anaplastic oligoastrocytomas were included in the study, with the majority of patients (57.3%) having glioblastomas. Treatment consisted of a fotemustine induction phase 75 to 110 mg/m2 weekly for 3 consecutive weeks, and, in nonprogressive patients, a maintenance phase with fotemustine 75 to 100mg/m2 every 3 weeks until evidence of progression or unacceptable toxicity. "As measured by MRI, we obtained only 1 complete response in patients with glioblastoma," Dr. Trevisan noted. "In patients with malignant astrocytic gliomas, we obtained 8 partial responses and 42 disease stabilisations." Patients with oligodendroglial tumours had 6 partial responses, and 14 of them experienced a disease stabilisation. The overall response rate (complete response plus partial response) was 13.5% and the overall stabilisation rate was 54.2%. Median time to progression was 2 months in patients with glioblastoma and anaplastic astrocytoma and 3 months in patients with oligodendroglial tumours. Progression-free survival (PFS) at 6 months was 46.4%, again with a better outcome in patients with oligodendroglial tumours (57.9% vs 43.9%). At 1 year, PFS decreased to an average of 12.3% (15.8% vs 11%). "The mean overall survival was 5.8 months, with 5.4 months in glioblastoma and anaplastic astrocytoma, and 6.4 months in oligodendroglial tumours," said Dr. Trevisan. Myelosuppression occurred in 86% of patients, and a moderate reversible hepatotoxicity was observed in 3.7%. Other adverse events included thromboembolic events and 1 case of a second tumour. "Fotemustine shows some activity in recurrent pretreated gliomas as a single agent, especially in oligodendroglial tumours," Dr. Trevisan concluded. "Further studies are needed to verify the efficacy of the drug as second-line treatment, alone or in association with other chemotherapeutic or targeted therapies," he said. A pilot study on the combination of fotemustine with bevacizumab in recurrent gliomas is currently ongoing at Dr. Trevisan's institution. Funding for this study was provided by Italfarmaco.
[Presentation title: Safety and efficacy of Fotemustine in Recurrent or Progressive Gliomas. Abstract O93]
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