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 auth ors evaluated the therapeutic efficacy of preirradiation gemcitabine chemot herapy followed by standard radiotherapy. METHODS, Twenty-one patients with newly diagnosed glioblastoma were enrolle d in a prospective unicenter trial of preirradiation gemcitabine chemothera py. Chemotherapy included up to 4 monthly cycles of intravenous gemcitabine (Day 1, Day 8, and Day 15; 1000 mg/m(2)). Involved field radiotherapy was given after chemotherapy or earlier in the case of disease progression or g emcitabine intolerance. RESULTS. With gemcitabine chemotherapy alone, there was a median progressio n free survival of 11 weeks and a progression free survival rate at 4 month s of 24%. In 18 of 21 patients who subsequently received a full course of r adiotherapy, the median progression free survival from the time of diagnosi s 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 thos e treated with gemcitabine plus radiotherapy. CONCLUSIONS, Gemcitabine followed by radiotherapy is a safe regimen for pat ients with newly diagnosed glioblastoma but the gemcitabine schedule used i n the current study did not appear to confer any survival advantage compare d with standard involved field radiotherapy alone. (C) 2001 American Cancer Society.