Temsirolimus (TEM) in endometrial cancer: Predictors of response and progression.

3090 Background: NCIC CTG conducted a phase II trial of the mTOR inhibitor TEM in endometrial cancer since this tumor is associated with frequent PTEN loss. Our earlier work did not show a relationship between response (or progression) and PTEN or other molecular markers. Because of evidence that toxicity may relate to efficacy outcomes for EGFR inhibitors (Wacker, Clin Cancer Res 2007; Jonker, NEJM 2007), we explored the correlation between toxicity and outcomes in our trial. Methods: Response results (RECIST) in 60 treated patients (pts) (33 chemonaive) were 5 PR, 32 SD, 17 PD, and 6 IN. All pts receiving > 1 cycle of TEM (n = 49) were included. Prior chemotherapy and worst cycle 1 toxicity (see Table) were evaluated as potential predictors for partial response (PR) or progression (PD), as well as maximum % decrease from baseline tumor size (TS) in a univariate analysis (UA). Multivariate analysis (MVA) assessed UA variables significant at p<0.1. Results: No significant predictor was found for PR. Only ...