Systemic sagopilone (ZK-EPO) treatment of patients with recurrent malignant gliomas.
It has been demonstrated that sagopilone (ZK-EPO) has antitumor activity in human orthotopic glioma models in vitro and in vivo. The objective of this study was to evaluate the safety and efficacy of ZK-EPO in patients with pretreated, recurrent malignant gliomas. Fifteen patients with recurrent malignant gliomas who had received prior surgery, radiotherapy, and >or=2 lines of alkylating chemotherapy were recruited. ZK-EPO (16 mg/m(2)) was administered iv for 3 h every 21 days. The primary end point was six months progression-free survival (PFS-6); secondary end points were safety, toxicity, response rate, and median time to progression (TTP). Magnetic resonance imaging (MRI) evaluations were performed every two cycles and toxicity was evaluated at each cycle using common terminology criteria for adverse events (CTCAE 3.0). A median of four cycles was administered. The median TTP was 13 weeks. PFS-6 was achieved in five patients (33%), three with glioblastoma multiforme and two with anaplastic astrocytoma. The most common treatment-related adverse event was neuropathy, which occurred in 6/15 patients. ZK-EPO had an acceptable safety profile and clinically relevant activity in patients with pretreated, recurrent malignant gliomas.
Silvani
Antonio
A
Department of Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria n° 11, 20133, Milan, Italy. silvani@istituto-besta.it.
Gaviani
Paola
P
Department of Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria n° 11, 20133, Milan, Italy.
Fiumani
Anna
A
Department of Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria n° 11, 20133, Milan, Italy.
Scaioli
Vidmer
V
Department of Clinical Neuro-Physiopathology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.
Lamperti
Elena
E
Department of Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria n° 11, 20133, Milan, Italy.
Eoli
Marica
M
Department of Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria n° 11, 20133, Milan, Italy.
Botturi
Andrea
A
Department of Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria n° 11, 20133, Milan, Italy.
Salmaggi
Andrea
A
Department of Neuro-Oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, via Celoria n° 11, 20133, Milan, Italy.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D052160:Benzothiazoles / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D034261:Epothilones / Q000627:therapeutic use*; D005260:Female; D005910:Glioma / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016019:Survival Analysis; D055815:Young Adult
D000970:Antineoplastic Agents; D052160:Benzothiazoles; D034261:Epothilones; C530494:sagopilone