Heterogeneity of treatment effects (HTE) in stage IV prostate cancer (S4PC).

Abstract

180 Background: HTE occurs when individual patient factors modify a treatment’s effect on health outcomes in a non-random and predictable manner. HTE results in specific subgroups of patients in the same study having different responses to the same treatment due to interactions between their individual factors and the treatment. Methods: A systematic literature review was conducted of articles published between 1946 and 2011. Inclusion criteria required that articles examine the impact of HTE factors on survival outcomes (OS, TTP, PFS) or QOL among S4PC patients, in the context of a specific treatment. The quality of evidence was graded as good, fair or poor, per AHRQ guidelines. Results: The search identified 2,659 articles of which 92 met study inclusion criteria. Most articles (46%) were post-hoc analyses of randomized clinical trials. PC treatments included chemotherapy, radiation, hormonal therapy (74%) and bone-modifying agents. HTE in S4PC was identified for both biologic and non-biologic factors. Factors related to clinical signs/symptoms, laboratory tests and disease severity have been extensively studied in the literature (Table). Age and race seldom showed any correlation with PC outcomes. Conclusions: Current evidence reveals diverse factors contributing to HTE in S4PC. Ultimately, such knowledge can help oncologists prescribe more personalized medicine, help patients make more informed treatment choices, and inform policy making and treatment coverage decisions. [Table: see text]