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Second line chemotherapy with docetaxel in patients with recurrent malignant glioma: a phase II study
M Sanson1, M Napolitano, R Yaya
1Fédération de neurologie Mazarin, H pital de la Salpêtrière, Paris, France. sanson@jussieu.fr
Abstract:
The objective of the study was to assess the efficacy of docetaxel in recurrent supratentorial malignant gliomas. The sample size of the study was determined by the Gehan's method for a response rate of 20% and a beta error of 5%. In the first step 14 patients (age 27-69, median 50; Karnofsky index 50-90, median 75) with recurrent malignant glioma after surgery, radiotherapy and nitrosourea, were enrolled (12 glioblastomas, 2 anaplastic astrocytomas). Docetaxel at the initial dose of 80 mg/m2 was administered every 3 weeks until progression or unacceptable toxicity. A total of 41 cycles was administered. Patients received a median of two cycles (range 1-6). No complete or partial response was observed. Therefore, according to the design of the study, no additional patients were enrolled and the trial was terminated. Two stabilizations were observed (14 and 15 weeks). Median TTP was 7 weeks (44 days). Median overall survival from recurrence was 26.5 weeks (6.4 months). Grade 3-4 neutropenia was observed in 8 patients (57%) but no life-threatening toxicity was observed. Other toxicities were uncommon and mild. Dose reduction was performed in 5 patients. This study suggests that docetaxel displayed no significant activity in patients with malignant recurrent gliomas.
Insights
Docetaxel showed no significant efficacy in treating recurrent malignant gliomas. The clinical trial was terminated early due to a lack of patient response to docetaxel treatment.
Area of Science:
- Neuro-oncology
- Clinical pharmacology
- Medical oncology
Background:
- Recurrent malignant gliomas have a poor prognosis.
- Limited effective treatment options exist for patients with recurrent supratentorial malignant gliomas.
- Docetaxel is an established chemotherapeutic agent with activity in various cancers.
Purpose of the Study:
- To evaluate the efficacy of docetaxel in patients with recurrent supratentorial malignant gliomas.
- To determine if docetaxel could achieve a 20% response rate in this patient population.
Main Methods:
- A prospective clinical trial was conducted.
- 14 patients with recurrent malignant glioma received docetaxel at 80 mg/m2 every 3 weeks.
- The study employed Gehan's method for sample size determination, with a planned response rate of 20% and a beta error of 5%.
Main Results:
- No complete or partial responses were observed in the 14 enrolled patients.
- Two patients achieved disease stabilization for 14 and 15 weeks.
- Median time to progression (TTP) was 7 weeks, and median overall survival was 26.5 weeks.
- Grade 3-4 neutropenia occurred in 57% of patients, but no life-threatening toxicities were reported.
Conclusions:
- Docetaxel demonstrated no significant anti-tumor activity in patients with recurrent supratentorial malignant gliomas.
- The trial was terminated early due to the lack of efficacy.
- Further investigation into docetaxel for this indication is not warranted based on these findings.