Surgery, tamoxifen, carboplatin, and radiotherapy in the treatment of newly diagnosed glioblastoma patients

A historically controlled phase II study was undertaken to investigate the efficacy and toxicity of a postoperative treatment consisting of high-dose continuous tamoxifen, carboplatin and radiotherapy in patients with newly d iagnosed glioblastoma. Between 1995 and 1998, 50 patients with newly diagno sed glioblastomas underwent surgery and were subsequently treated with 200 mg day(-1) tamoxifen continuously, 3 cycles of carboplatin (300 mg m(-2)), and radiotherapy. Survival data for a historical control group were calcula ted from respective prognostic indices and were obtained from studies with comparable patient populations treated with operation and radiotherapy only . In our study, the median time to tumor progression was 30 weeks and the m edian survival time (MST) 55 weeks (95% confidence interval: 46-63 weeks). The MST of the control group (48 weeks) showed to be within this interval. In addition to already known prognostic factors in malignant gliomas (age, Karnofsky performance score, extent of tumor resection), the gender (female s lived longer than males, p = 0.0025) showed to influence survival. Seriou s side effects (thrombosis, pulmonary embolism) occurred in 6 patients. A h igh incidence of multifocal tumor recurrences (33%), which might be related to study-treatment, was observed. In conclusion, the combined therapy fail ed to demonstrate a higher efficacy than standard treatment for glioblastom a patients.