Patient-reported pain and other symptoms as prognostic factors for overall survival (OS) in a phase III clinical trial of patients with advanced breast cancer.

1068 Background: The safety and efficacy of gemcitabine plus paclitaxel versus paclitaxel in advanced breast cancer after anthracycline-based adjuvant therapy has been reported previously (Albain et al. 2008). This post-hoc analysis evaluates the prognostic effect of baseline scores of the Brief Pain Inventory short form (BPI-SF) and the Rotterdam Symptom Checklist (RSCL) on OS. Methods: Patients completed theBPI-SF and the RSCL. BPI “worst pain” item and BPI interference subscale scores range from 0 (no pain or interference with daily living) to 10. Four RSCL subscales were transformed to 0-100, with 100 as best score. Univariate Cox models were used to determine the prognostic effect of each measure on OS. Multivariate Cox models were used to determine the prognostic effect of each measure in the presence of 11 demographic/clinical variables, including Karnofsky performance status, age, and estrogen and progesterone receptor status. Kaplan-Meier curves and log-rank tests were used to compare OS among pa...