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Assessing the benefit-risk of new treatments using generalised pairwise comparisons: the case of erlotinib in pancreatic cancer.

ABSTRACT: Efficacy and safety are the two considerations when characterising the effects of a new therapy. We sought to apply an innovative method of assessing the benefit-risk balance using data from a completed randomised controlled trial that compared erlotinib vs placebo added to gemcitabine in patients with advanced pancreatic cancer (NCIC CTG PA.3).We applied generalised pairwise comparisons with several prioritised outcome measures (e.g., one or more benefit outcomes and one or more risk outcomes). Here, the first priority outcome was overall survival (OS) time. Differences in OS that exceeded 2 months were considered clinically meaningful. The second priority outcome was toxicity. The overall treatment effect was quantified using the proportion in favour of erlotinib, which can be interpreted as the net proportion of patients who have a better overall outcome with erlotinib as compared with placebo. Sensitivity analyses were performed.In this trial 569 patients were randomly assigned in a 1 : 1 ratio to receive gemcitabine plus either erlotinib or a matched placebo. Overall, the method indicated no statistically significant overall treatment effect in favour of erlotinib; if anything, the point estimate of the net proportion leaned in favour of the placebo group (overall proportion in favour of erlotinib=-3.6%, 95% CI, -14.2- 7.1%; P=0.51). The net proportion was never in favour of the erlotinib group throughout all sensitivity analyses.Generalised pairwise comparisons make it possible to assess the benefit-risk balance of new treatments using a single statistical test for any number of prioritised outcomes. The benefit-risk assessment was not in favour of adding erlotinib to gemcitabine for the treatment of patients with advanced pancreatic cancer.

SUBMITTER: Peron J

PROVIDER: S-EPMC4366896 | biostudies-other | 2015 Mar

REPOSITORIES: biostudies-other

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Project description:When the in/consistency in Pairwise Comparisons (PCs) is taken into consideration as the subarea of the Multi Attribute Decision Making (MADM) scientific field, it has many repercussions in various types of research areas including different modelling scenarios e.g. reduction of inconsistency during PCs, deriving appropriate consistency thresholds for inconsistent Pairwise Comparison Matrices (PCMs), completing of incomplete PCMs, aggregating of individual PCMs in relation to Group Decision Making (GDM) aspects, and PCMs in/consistency relation to credibility of Priority Vectors (PV) derived from PCMs with the application of various Priorities Deriving Methods (PDMs). The examination objective in the latter area of research is the uncertainty related to the inexactitude of prioritization based on derived PVs. However, only few research studies examine this problem from the perspective of PCM applicability for credible designation of decision maker's (DM) priorities in the way that leads to minimization of the prioritization uncertainty related to possible, and sometimes very probable, ranking fluctuations. This problem constitutes the primary area of interest for this research paper as no research study was thus far identified that examines this problem from the perspective of consistent PCMs. Hence, a research gap was identified. Thus, the objective of this research paper is to fill in this scientific gap. The research findings have serious repercussions in relation to prioritization quality with the application of PCs methodology, mostly in relation to the interpretation and reliability evaluation of prioritization results. Firstly, the research study outcome changes the perspective of the rank reversal phenomenon, which shed new light on many research studies that have been presented in the subject's literature for many decades. Secondly, the research study results throw new light on the discussion concerning the fuzziness of AHP's results. Last but not least, the effect of the research opens the unique opportunity to evaluate the prioritization outcome obtained within the process of consistent PCs from the well-known perspective of statistical hypothesis testing i.e. the probability designation of the chance that accepted ranking results which were considered as correct due to low probability of change may be incorrect, hence they should be rejected, and the probability designation of the chance that rejected ranking results which were considered as incorrect due to high probability of change may be correct and should be accepted. The paramount finding of the research is the fact that consistent PCMs provide PVs, which elements cannot be considered as established, but only approximated within certain confidence intervals estimated with a certain level of probability. As problems related to heuristics can be analyzed only via a computer simulation process, because they cannot be mathematically determined, the problem examined in this research paper is examined via Monte Carlo simulations, appropriately coded and executed with the application of Wolfram's Mathematica Software. It is believed that this research findings should be very important and useful for all decision makers and researchers during their problems' examinations that relate to prioritization processes with the application of PCs methodology.

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Assessing the benefit-risk of new treatments using generalised pairwise comparisons: the case of erlotinib in pancreatic cancer.

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