Effect of temozolomide chronotherapy in patients with high-grade glioma.

Temozolomide Chronotherapy (sleep phase)
DOI: 10.1200/jco.2020.38.15_suppl.e14525 Publication Date: 2020-05-25T15:18:08Z
ABSTRACT
e14525 Background: High grade gliomas (HGG) (the most common being glioblastoma) are the primary CNS malignancy in adults. Mainstay of therapy is surgical resection followed by concurrent radiation and temozolomide (TMZ) adjuvant TMZ. Unfortunately, prognosis remains poor optimization current critical. Chronotherapy defined as improvement treatment outcomes maximizing efficacy minimizing toxicity administering medications accordance with biological rhythms patient. In a mouse model, there was greater anti-tumor during morning administration This trial designed to determine feasibility potential clinical impact chrono-therapeutically TMZ patients HGG. Methods: Adult ( > 18 years) HGG (WHO Grade III/IV) were eligible. Patients screened consented prior initiation monthly therapy. Eligible randomized (AM) before 10AM or evening (PM) after 8PM. Pill diaries recorded for drug time compliance. Fact-Br Quality Life (QoL) surveys administered at enrollment end measure differences QoL both groups. Circadian rhythm Actiwatch. Adverse events (AE), overall survival (OS) progression free (PFS) measured each group. Results: At submission, total 28 evaluated. 15 AM group 13 PM It feasible participants take per study assignment. There no significant difference based on dataset four main categories physical well-being, social/family functional well-being emotional well-being. The Friedman’s two-way nonparametric ANOVA tests used analyze across points. Cytopenias known adverse effect trend towards worsening lymphocyte counts compared group, although not statistically significant. statistical significance PFS OS newly diagnosed glioblastoma. Conclusions: feasible. A noted but No noted, sample size too small effectively assess this. larger will need be conducted chronotherapy survival. Clinical information: NCT02781792.
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