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Publication: Statistical methodology & quality of life and MA5/MA12

Predictive significance of an optimized panel for basal-like breast cancer: Results from the Canadian Cancer Trials Group MA.5 and MA.12 phase III clinical trials

Accurate IHC biomarkers incorporating nestin positivity or inositol polyphosphate-4-phosphate (INPP4B) loss have recently been optimized to identify the basal-like intrinsic breast cancer subtype regardless of estrogen, progesterone, or Her2 status. We examined the predictive capacity of these basal biomarkers in the CCTG MA.5 chemotherapy and MA.12 endocrine therapy trials.

Karama Asleh, Dongsheng Tu, Dongxia Gao, Vivien Bramwell, Mark N. Levine, Kathleen I. Pritchard, Lois E. Shepherd and Torsten O. Nielsen

Clinical Cancer Research DOI: 10.1158/1078-0432.CCR-21-1942


A Joint Model for Longitudinal Outcomes with Potential Floor or Ceiling Effects and Survival Times, with Applications to Analysis of Quality of Life Data from a Cancer Clinical Trial

Longitudinal data on patient reported outcomes (PROs), such as quality of life of patients, are frequently collected in clinical trials and other medical studies. Joint analysis of these data with survival times may improve the accuracy of statistical inferences, especially when PRO measurements may be missing after the death of patients. Classical linear mixed models are often used as the models for the longitudinal measurements in a joint analysis but it may not be suitable for longitudinal PRO measurements with potential floor or ceiling effect caused by a large portion of patients who report either a maximum or minimum score. In this paper, we introduce a new joint model which uses a longitudinal Tobit model for the longitudinal outcomes with potential floor and ceiling effect and a Cox proportional hazard model for survival time with a random effect connecting these two models.

Zhanfeng Wang, Honghong Xu, Haijiao Liu, Hui Song, Dongsheng Tu

Stat DOI: 10.1002/sta4.412