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• W2483328169 abstract "Purpose: Temozolomide (TMZ) is standard therapy, increasing efficacy in newly diagnosed or recurrent primary central nervous system (CNS) tumors. A dose-dense schedule was designed to better define the proper efficacy/safety balance and discriminate sensitive/resistant subgroups according to O6-methylguanine-DNA methyltransferase (MGMT) expression. A dose-finding/phase II study was designed to evaluate recommended dose, safety, activity and efficacy of TMZ dose-dense, according to 5 days on/9 days off (5/14 d) regimen. Patients and methods: Upfront or recurrent CNS patients were enrolled. Dose-finding was designed according to intra- and inter-patient approach in 5 dose levels to evaluate TMZ recommended dose: 150, 180 mg/m2 d1-5 every 21 days; 150, 180, 200, mg/m2 d1-5 every 14 days. Safety was evaluated according to limiting toxicity syndromes (LTS), defined as LTS single site, consisting of LT alone (LTS-ss), and LTS multiple sites (LTS-ms), double LT or LT associated to other G2-3 not LT. Efficacy was evaluated and compared by log-rank test. Results: Thirty-four CNS patients were enrolled (19 glioblastoma, 13 grade III glioma, 1 grade II multiple relapses, 1 misunderstood diagnosis). First 13 patients were enrolled in the dose-finding. First patient was treated at I-II dose level, without LT. At III level, the first patient and 2 new patients were treated, without LT. At IV level, 7 patients were treated with 1 LTS-ms (G3 thrombocytopenia and G3 neutropenia for 4 weeks). At V level 3 patients were treated, 2 LT (G3 thrombocytopenia, G2 hepatic toxicity for >4 weeks). Thus, recommended dose was 180 mg/m2 d1-5 every 14 days. More, 21 patients were treated in the phase II trial. Objective response rate was 14.7%, disease control rate 55.8%. At 33 weeks median follow-up, progression free survival (PFS) and overall survival (OS) were 20 and 47 weeks, respectively; PFS-6 months 35%. PFS and OS were not significantly different in low (0-10%) and high (>10%) MGMT protein expression patients, while OS was significantly different in relapse and sub-total disease (72 and 40 weeks, p 0.029), respectively. Cumulative G3-4 toxicities were: leucopenia 11.7%, neutropenia 11.7%, thrombocytopenia 14.6%, anemia 2.9%, asthenia 2.9%. LTS were 5 (14.7%), LTS-ss 1, LTS-ms 4. Discussion: The present dose-finding study proposed TMZ dose-dense regimen as safely administered at 180 mg/m2 d1-5 every 14 days, recommended dose. Preliminary efficacy data showed promising PFS and OS." @default.
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• W2483328169 date "2015-10-01" @default.
• W2483328169 modified "2023-09-26" @default.
• W2483328169 title "Temozolomide dose-dense regimen in high grade gliomas: dose-finding/phase II study" @default.
• W2483328169 doi "https://doi.org/10.1093/annonc/mdv348.19" @default.
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