Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): Quality of life (QoL) and pain palliation results from the global phase III study

Abstract

621 Background: At ASCO 2003, interim results of GT vs T in MBC patients (pts) were presented (#25), demonstrating significantly longer time to disease progression for GT with manageable toxicity. Here we present the results of the pain and QoL assessments. Methods: Pts with MBC with prior (neo)adjuvant anthracyclines were randomized to GT (G 1250 mg/m2 d1,8; T 175 mg/m2 d1) or T (175 mg/m2 d1) q21d. Pts completed the Brief Pain Inventory (BPI) and Rotterdam Symptom Checklist (RSCL) prior to each cycle; only data from validated translations were included. Analgesic level was assessed prior to each cycle. Mixed effect repeated-measure analysis was used to study overall and cycle-specific differences. This abstract presents the results of sensitivity analyses with five longitudinal models (e.g., pattern mixture models) that were performed to study potential bias due to informative dropout. Results: 529 pts were randomized (267 GT and 262 T). Arms were balanced; 70% had visceral metastases and 72% had KPS 90...