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• W2810361664 abstract "To assess the use of historical trial data to inform extrapolations of immature survival data within a Bayesian framework in comparison to standard approaches. For the extrapolations, immature overall survival (OS) data of VISTA trial was selected. VISTA evaluated the effect of melphalan and prednisone (MP) with or without bortezomib (V) in multiple myeloma patients. Also, a historical trial with mature OS data for the MP arm in the same population was retrieved. We proposed a two-stage approach where we first based the model selection on the historical trial data. Secondly, the derived shape parameter of the best fitting parametric model on the historical trial was used to inform the shape parameter of the corresponding model fit over the 30 months data of the VISTA trial. As standard approaches, the best fitting model on 30 months VISTA data and best fitting model on the historical trial data were used to fit 30 months VISTA data. The extrapolations with all the approaches were compared against 75 months VISTA trial data. The two-stage approach resulted in mean OS of 59.3 (95%CrI:49.0-72.1) and 85.9 (95%CrI: 69.5-104.9) months for MP and VMP arms, respectively. A Lognormal model, best fit over the VISTA 30 months data, resulted in the mean OS of 101.9 (95%CrI:89.0-115.0) and 120.0 (95%CrI:106.0-133.7) months for MP and VMP arms, respectively. A Weibull model, best fit over the historical trial, mean OS was estimated to be 67.3 (95%CrI:53.1-84.0) months for MP and 99.8 (95%CrI:75.3-117.9) months for VMP. Compared with the VISTA 75 months data, the two-stage Bayesian approach improved the fit by 42% for MP and 38% for VMP compared to the standard Weibull model. The two-stage Bayesian approach resulted in a better fit over survival data and reduced uncertainty compared to standard extrapolation approaches." @default.
• W2810361664 created "2018-07-10" @default.
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• W2810361664 date "2018-05-01" @default.
• W2810361664 modified "2023-09-27" @default.
• W2810361664 title "The use of Historical Trial Data to Inform Extrapolations of Immature Survival Data within a Bayesian Framework in Comparison to Standard Approaches" @default.
• W2810361664 doi "https://doi.org/10.1016/j.jval.2018.04.1489" @default.
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