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. Median cycles were 6 for GT (range, 0–20) and 5 for T (range, 0–16). 291 pts completed BPI and 350 completed RSCL. 85% of expected questionnaires were completed. The mean RSCL global QoL score for patients receiving GT was significantly and consistently better than that reported by T arm patients; this difference was also clinically significant. No consistent differences were seen in the other RSCL scales. Mean changes and trends in pain intensity and interference were similar across treatment arms. Data from the sensitivity analyses consistently supported these findings. Of pts requiring analgesics at baseline (n=216), more GT pts were able to decrease analgesic level for >1 cycle (25 vs 15%). Conclusions: For pts with MBC, the addition of gemcitabine to paclitaxel extended time to progression and resulted in a better global rating of QoL. The combination palliated pain as well as monotherapy in the predominantly asymptomatic population. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly & Co. Eli Lilly & Co. Eli Lilly & Co. Eli Lilly & Co.