Impact of symptoms and toxicity on quality of life: Exploratory analysis of gemcitabine plus docetaxel vs capecitabine plus docetaxel in metastatic breast cancer

682 Background: A recent phase III trial comparing gemcitabine-docetaxel (GD) with capecitabine-docetaxel (CD) for metastatic breast cancer (MBC) found comparable progression-free survival but patients (pts) on GD had less toxicity (Chan, ASCO 2005). To better understand how quality of life (QoL) is impacted by toxicity and symptoms, we conducted an exploratory analysis. Methods: The study had 305 pts who relapsed after anthracycline-based treatment either in (neo)adjuvant or first-line MBC. Pts were randomized to GD or CD for 21-day cycles until PD or unacceptable toxicity. QoL was assessed every cycle with Rotterdam Symptom Checklist (RSCL). Only pts with RSCL data were included in the QoL analysis. Comparison between arms of changes from baseline in RSCL dimensions at each cycle were analyzed using analysis of co-variance (ANCOVA). Because the physical symptom distress scale (PSDS) includes symptom- and toxicity-related items, distributions of responses to each item were explored. Results: 302 pts rece...