Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas.

作者: Kathleen R. Lamborn , W. K. Alfred Yung , Susan M. Chang , Patrick Y. Wen , Timothy F. Cloughesy

DOI: 10.1215/15228517-2007-062

关键词: Progression-free survivalPhases of clinical researchSurgeryGliomaProportional hazards modelClinical trialHazard ratioOncologyBrain tumorInternal medicineMedicineChemotherapy regimen

摘要: The North American Brain Tumor Consortium (NABTC) uses 6-month progression-free survival (6moPFS) as the efficacy end point of therapy trials for adult patients with recurrent high-grade gliomas. In this study, we investigated whether progression status at 6 months predicts from that time, implying potential prolonged if could be delayed. We also evaluated earlier time points to determine assessment alters strength prediction. Data were 596 patient enrollments (159 grade III gliomas and 437 IV tumors) in NABTC phase II protocols between February 1998 December 2002. Outcome was assessed statistically using Kaplan-Meier curves Cox proportional hazards models. Median survivals 39 30 weeks tumors, respectively. Twenty-eight percent 16% tumors had >26 weeks. Progression 9, 18, 26 predicted those times or (p < 0.001 hazard ratios 0.5 all cases). Including KPS, age, number prior chemotherapies, response a multivariate model did not substantively change results. is strong predictor survival, 6moPFS valid malignant glioma. Earlier assessments may incorporated design future clinical trials.

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