Dataset Information

Retrospective analysis of safety and feasibility of a 3 days on/11 days off temozolomide dosing regimen in recurrent adult malignant gliomas.

ABSTRACT: We report the safety and feasibility of a 3 days on/11 days off temozolomide regimen for the treatment of recurrent malignant gliomas.Fifteen adult patients were treated; 14 were treated with 300 mg/m(2) and one treated with 250 mg/m(2).We reviewed the toxicity, progression-free survival (PFS), overall survival and objective response rate. Two patients (13%) experienced grade 3 nausea/vomiting and six patients (40%) experienced grade 3 lymphopenia. Dose reduction and treatment delay occurred in eight (53%) cases. One patient discontinued treatment due to uncontrolled nausea/vomiting. Median PFS for glioblastoma patients was 4.1 months and 6-month PFS was 25%. Twelve patients exhibited stable disease (86%), one patient (7%) had progressive disease and one patient (7%) showed a partial response.The '3 on/11 off' temozolomide regimen for recurrent high-grade gliomas was tolerable and warrants further study in a larger, prospective study.

SUBMITTER: van Vugt VA

PROVIDER: S-EPMC4214215 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Retrospective analysis of safety and feasibility of a 3 days on/11 days off temozolomide dosing regimen in recurrent adult malignant gliomas.

van Vugt Vincent A VA Piccioni David E DE Brown Bradley D BD Brown Tiffany T Saria Marlon G MG Juarez Tiffany T Kesari Santosh S

CNS oncology 20140701 4

<h4>Aims</h4>We report the safety and feasibility of a 3 days on/11 days off temozolomide regimen for the treatment of recurrent malignant gliomas.<h4>Patients & methods</h4>Fifteen adult patients were treated; 14 were treated with 300 mg/m(2) and one treated with 250 mg/m(2).<h4>Results</h4>We reviewed the toxicity, progression-free survival (PFS), overall survival and objective response rate. Two patients (13%) experienced grade 3 nausea/vomiting and six patients (40%) experienced grade 3 lymp ...[more]

PMID: 25286037

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Project description:OBJECTIVE:To assess the efficacy and cost-effectiveness of modulated electrohyperthermia (mEHT) concurrent to dose-dense temozolomide (ddTMZ) 21/28 days regimen versus ddTMZ 21/28 days alone in patients with recurrent glioblastoma (GBM). DESIGN:A cohort of 54 patients with recurrent GBM treated with ddTMZ+mEHT in 2000-2005 was systematically retrospectively compared with five pooled ddTMZ 21/28 days cohorts (114 patients) enrolled in 2008-2013. RESULTS:The ddTMZ+mEHT?cohort had a not significantly improved mean survival time (mST) versus the comparator (p=0.531) after a significantly less mean number of cycles (1.56 vs 3.98, p<0.001). Effect-to-treatment analysis (ETA) suggests that mEHT significantly enhances the efficacy of the ddTMZ 21/28 days regimen (p=0.011), with significantly less toxicity (no grade III-IV toxicity vs 45%-92%, p<0.0001). An estimated maximal attainable median survival time is 10.10 months (9.10-11.10). Cost-effectiveness analysis suggests that, unlike ddTMZ 21/28 days alone, ddTMZ+mEHT is cost-effective versus the applicable cost-effectiveness thresholds €US$25?000-50?000/quality-adjusted life year (QALY). Budget impact analysis suggests a significant saving of €8?577?947/$11?201?761 with 29.1-38.5 QALY gained per 1000 patients per year. Cost-benefit analysis suggests that mEHT is profitable and will generate revenues between €3?124?574 and $6?458?400, with a total economic effect (saving+revenues) of €5?700?034 to $8?237?432 per mEHT device over an 8-year period. CONCLUSIONS:Our ETA suggests that mEHT significantly improves survival of patients receiving the ddTMZ 21/28 days regimen. Economic evaluation suggests that ddTMZ+mEHT is cost-effective, budget-saving and profitable. After confirmation of the results, mEHT could be recommended for the treatment of recurrent GBM as a cost-effective enhancer of ddTMZ regimens, and, probably, of the regular 5/28 days regimen. mEHT is applicable also as a single treatment if chemotherapy is impossible, and as a salvage treatment after the failure of chemotherapy.

Dataset Information

Retrospective analysis of safety and feasibility of a 3 days on/11 days off temozolomide dosing regimen in recurrent adult malignant gliomas.

Publications

Retrospective analysis of safety and feasibility of a 3 days on/11 days off temozolomide dosing regimen in recurrent adult malignant gliomas.

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