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Phase III study of Enzastaurin compared with Lomustine in the treatment of recurrent intracranial glioblastoma

Purpose - - This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4). - - Patients and Methods - - Patients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading d...

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Hauptverfasser: Wick, Wolfgang (VerfasserIn) , Puduvalli, Vinay K. (VerfasserIn) , Chamberlain, Marc C. (VerfasserIn) , Bent, Martin J. van den (VerfasserIn) , Carpentier, Antoine F. (VerfasserIn) , Cher, Lawrence M. (VerfasserIn) , Mason, Warren (VerfasserIn) , Weller, Michael (VerfasserIn) , Hong, Shengyan (VerfasserIn) , Musib, Luna (VerfasserIn) , Liepa, Astra M. (VerfasserIn) , Thornton, Donald E. (VerfasserIn) , Fine, Howard A. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: [March 1, 2010]
In: Journal of clinical oncology
Year: 2010, Jahrgang: 28, Heft: 7, Pages: 1168-1174
ISSN:1527-7755
DOI:10.1200/JCO.2009.23.2595
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2009.23.2595
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2009.23.2595
Volltext
Verfasserangaben:Wolfgang Wick, Vinay K. Puduvalli, Marc C. Chamberlain, Martin J. van den Bent, Antoine F. Carpentier, Lawrence M. Cher, Warren Mason, Michael Weller, Shengyan Hong, Luna Musib, Astra M. Liepa, Donald E. Thornton, and Howard A. Fine
Beschreibung
Zusammenfassung:Purpose - - This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4). - - Patients and Methods - - Patients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading dose, day 1) or lomustine (100 to 130 mg/m2, day 1). Assuming a 45% improvement in progression-free survival (PFS), 397 patients were required to provide 80% power to achieve statistical significance at a one-sided level of .025. - - Results - - Enrollment was terminated at 266 patients (enzastaurin, n = 174; lomustine, n = 92) after a planned interim analysis for futility. Patient characteristics were balanced between arms. Median PFS (1.5 v 1.6 months; hazard ratio [HR] = 1.28; 95% CI, 0.97 to 1.70), overall survival (6.6 v 7.1 months; HR = 1.20; 95% CI, 0.88 to 1.65), and 6-month PFS rate (P = .13) did not differ significantly between enzastaurin and lomustine, respectively. Stable disease occurred in 38.5% and 35.9% of patients and objective response occurred in 2.9% and 4.3% of patients, respectively. Time to deterioration of physical and functional well-being and symptoms did not differ between arms (HR = 1.12; P = .54). Four patients discontinued enzastaurin because of drug-related serious adverse events (AEs). Eleven patients treated with enzastaurin died on study (four because of AEs; one was drug-related). All four deaths that occurred in patients receiving lomustine were disease-related. Grade 3 to 4 hematologic toxicities were significantly higher with lomustine (46 events) than with enzastaurin (one event; P ≤ .001). - - Conclusion - - Enzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma.
Beschreibung:Gesehen am 19.12.2023
Beschreibung:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2009.23.2595

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