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Semiparametric regression analysis for time-to-event marked endpoints in cancer studies.

In cancer studies the disease natural history process is often observed only at a fixed, random point of diagnosis (a survival time), leading to a current status observation (Sun (2006). The statistical analysis of interval-censored failure time data. Berlin: Springer.) representing a surrogate (a mark) (Jacobsen (2006). Point process theory and applications: marked point and piecewise deterministic processes. Basel: Birkhauser.) attached to the observed survival time. Examples include time to recurrence and stage (local vs. metastatic). We study a simple model that provides insights into the relationship between the observed marked endpoint and the latent disease natural history leading to it. A semiparametric regression model is developed to assess the covariate effects on the observed marked endpoint explained by a latent disease process. The proposed semiparametric regression model can be represented as a transformation model in terms of mark-specific hazards, induced by a process-based mixed effect. Large-sample properties of the proposed estimators are established. The methodology is illustrated by Monte Carlo simulation studies, and an application to a randomized clinical trial of adjuvant therapy for breast cancer.