This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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583
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Type:
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Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306424 |
Title:
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Statistical Methods for a Phase II Oncology Trial with a GMI Endpoint
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Author(s):
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Stephanie Ann Kovalchik*+ and William Leonard Mietlowski
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Companies:
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University of California, Los Angeles and Novartis Oncology
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Address:
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Department of Biostatistics UCLA School of Public , Los Angeles, CA, 90095-1772,
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Keywords:
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phase II design ;
progression-free survival ;
growth modulation index ;
cytostatic agent ;
time to progression ;
paired failure times
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Abstract:
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For cytostatic cancer therapies, alternatives to traditional phase II end points are needed. Von Hoff (1998) proposed an intrapatient progression-free survival (PFS) ratio, the growth modulation index (GMI). Current practice in estimation of the GMI success rate is conservative and omits a measure of uncertainty.
We investigated methods for estimating the GMI success rate, including maximum-likelihood strategies and an approach using midranks for paired survival outcomes (Hudgens and Satten (2002)). Estimators were applied to a phase II GMI data set (Bonetti et al. (2001)). With simulation studies, a rank-based estimator had the most favorable properties. Its point estimate bias was consistently within 1.5%; its bias and precision were robust over a range of effect and censoring scenarios. Future GMI reporting should consider adopting the midrank methodology.
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