Department of Neuro-oncology, Fondazione IRCCS Istituto Neurologico " Carlo Besta", Via Celoria, 11, Milan, 20133, Italy, silvani@istituto-besta.it.
The purpose of this study was to evaluate safety and efficacy of Procarbazine (PCB) and fotemustine (FTM) combination in the treatment of pre-temozolomide treated, recurrent GBM patients\. The primary end-point was progression free survival at 6 months (PFS-6)\. Secondary end-points were overall survival, response rates (CR + PR) and toxicity\. About 54 patients (41 men and 13 women) aged 26-68 years (median age, 53.5 years) with recurrent GBM were treated\. PCB was administered as an oral dosage of 450 mg on days 1-2 and a total dose of 300 mg on day 3\. FTM was administered on day 3, 3 h after the last PCB intake at a dose of 110 mg/mq/BSA\. The treatment was repeated every 5 weeks\. Treatment was continued for a maximum of six cycles or until disease progression\. After two cycles of chemotherapy: 6 patients (11.2%) experienced a neuroradiographic partial response (PR), 29 patients (53.7%) had stable disease (SD), and 19 patients (35.1%) had progressive disease (PD)\. For the whole group of patients, the median PFS was 19.3 weeks (95% CI, 14.1-24.4 weeks), and PFS-6 was 26.7% (95% CI, 10.6-42.8%)\. Overall MST from the beginning of PCB + FTM chemotherapy was 28.7 weeks (95% CI, 24.8-32.7 weeks)\. At 6 and 12 months, 64.4% (95% CI, 51.5-77.3%) and 23.6% (95% CI, 10.1-37.1%) of patients were alive\. The median survival time calculated from the first diagnosis was 20.8 months (95% CI, 16.7-24.8)\. We concluded that the PCB + FTM combination as done in the current trial for patients with recurrent GBM after treatment with TMZ showed some benefit with regards to increased survival and that a Phase III trial is warranted.
PMID: 17576523 [PubMed - as supplied by publisher]
