Quality-Adjusted Survival Analysis Under Therapeutic Setting

• Activity Number: 421
• Type: Topic Contributed
• Date/Time: Tuesday, August 6, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Suddhasatta Acharyya*+ and Ren He
• Companies: Novartis Pharmaceuticals Corporation and UCLA
• Keywords: survival ; quality-of-life ; oncology

Abstract

A critical question, especially, in the context of oncology trials is whether and how to incorporate efficacy endpoints such as death or disease progression into the mix containing one or more instrument-based metrics. Commonly, a composite endpoint that incorporates both patient-reported subjective outcomes and objectively measured efficacy endpoints (such as disease progression or death) is used. Such an approach could be problematic, especially, when working with a time-to-event composite end-point (such as 'time to deterioration' or TTD), as it often requires specifying ad-hoc rules for defining events and censorings. An alternative approach is to use a modified overall survival type analysis, where instead of the usual survival-time, a 'quality-adjusted' version of it is analyzed. One popular such measure is the Q-TWiST, which is described as the 'time without symptoms and toxicity'. Originally, QTWiST was developed for the adjuvant setting but has since been extended in several directions. In this project, we adapt the QTWiST methodology to our specific situation, which is a two-arm randomized phase III oncology study, in a therapeutic setting.