Abstract
Purpose: To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC).Materials and Methods: Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD: 260 mg/m2 vs. MD: 220 mg/m2 vs. LD: 180 mg/m2). QoL was assessed at baseline and during the 2nd, 4th and 6th courses of treatment using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), Cancer Fatigue Scale (CFS) and EuroQol 5-Dimension (EQ-5D). Comparisons were performed with mixed-model repeated-measures (MMRM).Results: A total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD p<0.001, LD vs. SD p<0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (p=0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD p=0.011, LD vs. SD p<0.001). Conclusion: QoL of patients treated with 220 or 180 mg/m2 of q3w nab-PTX was significantly better than that of patients treated with 260mg/m2.
Randomized, Optimal Dose Finding, Phase Ii Study of Tri-Weekly NabPaclitaxel in Patients with Metastatic Breast Cancer (ABROAD)