A phase II study of paclitaxel in chemonaive patients with recurrent high-grade glioma

Background: The prognosis of malignant gliomas remains poor. In recurrent disease, chemotherapy can be considered. Patients and methods: In this phase II study we determined the anti-tumour efficacy of paclitaxel 200 mg/m(2) in a three-hour intravenous infusion every three weeks in chemonaive patients with recurrent high-grade glioma in terms of response, survival, and quality of life. Results: In 17 patients (14 glioblastoma multiforme, 3 anaplastic astrocytoma) 69 paclitaxel cycles were administered. Partial or complete responses were not observed. Stable disease for four to six months was observed in five patients (29%). Median time to progression and median survival were two and 10 months, respectively. Toxicity due to paclitaxel was as to be expected and minor in most cases. Quality of life and mood estimates appeared rather stable over time. Conclusions: We conclude that three-weekly 200 mg/m(2) paclitaxel chemotherapy for patients with recurrent high-grade gliomas did not lead to major complications or adverse effects on quality of life and mood. However, this therapy is of only very limited value in terms of response and survival in such patients.