Relationship of time to relapse (TTR) and survival post relapse (SPR): Exploration of risk factors from the first annual follow-up data set of randomized pbo-controlled study of oregovomab (OV) as a consolidation therapy of patients with advanced ovarian cancer (OC)

Abstract

5069 Background: OV is a MAb specific for CA125 being studied as an immunotherapeutic in OC. A recently reported randomized phase II study utilized TTR as a primary endpoint as a surrogate of survival. The study identified a favorable subpopulation (SFLT) that appeared to benefit from OV antibody stimulated immune activation (Proc ASCO 2003 #660). A long-term follow-up program to survey long term outcomes is in progress. Results of the first annual follow-up survey have been analyzed to address the relationship between TTR and SPR. As SPR varies between patients, factors that predict SPR are highly relevant to individualized patient management strategy following front-line therapy. Intervention with cytotoxic, cytostatic, immune modifying, or combination therapies must satisfy a rigorous analysis of risk benefit to be recommended. The ability to extrapolate TTR data to survival is dependent on an appreciation of factors that influence SPR. Results: 145 OC patients were entered into follow-up, with 67 defi...