Preirradiation gemcitabine chemotherapy for newly diagnosed glioblastoma. A phase II study

BACKGROUND: The median survival for patients with glioblastoma is reported to be 12 months. To improve the outcome for glioblastoma patients, the authors evaluated the therapeutic efficacy of preirradiation gemcitabine chemotherapy followed by standard radiotherapy. METHODS: Twenty-one patients with newly diagnosed glioblastoma were enrolled in a prospective unicenter trial of preirradiation gemcitabine chemotherapy. Chemotherapy included up to 4 monthly cycles of intravenous gemcitabine (Day 1, Day 8, and Day 15; 1000 mg/m2). Involved field radiotherapy was given after chemotherapy or earlier in the case of disease progression or gemcitabine intolerance. RESULTS: With gemcitabine chemotherapy alone, there was a median progression free survival of 11 weeks and a progression free survival rate at 4 months of 24%. In 18 of 21 patients who subsequently received a full course of radiotherapy, the median progression free survival from the time of diagnosis was 8 months and the progression free survival rate at 12 months was 17% (3 of 18 patients). The median overall survival was 11 months. There was no specific treatment-related neurotoxicity reported. Neither age nor extent of residual postoperative tumor predicted the duration of progression free survival in patients treated with gemcitabine chemotherapy alone or in those treated with gemcitabine plus radiotherapy. CONCLUSIONS: Gemcitabine followed by radiotherapy is a safe regimen for patients with newly diagnosed glioblastoma but the gemcitabine schedule used in the current study did not appear to confer any survival advantage compared with standard involved field radiotherapy alone.