QOL Evaluation of Nab-Paclitaxel and Docetaxel for Early Breast Cancer

Abstract

Objective: A previous randomized phase II study showed that neoadjuvant nab-paclitaxel (nab-PTX) 100 mg/m2) was effective and well-toleratedin patients with HER2-negative early-stage breast cancer, compared with docetaxel (DTX). We evaluated patient outcomes in terms of the Functional Assessment of Cancer Therapy-Breast (FACT-B), as a measure of health-related quality of life (HRQoL).Materials and Methods: Stage I–III HER2-negative breast cancer patients from the previous study were included. They received either fourcycles of nab-PTX (100 mg/m2 days 1/8/15) every 4 weeks, or DTX (75 mg/m2 day 1) every 3 weeks, both followed by four cycles of 5-fluorouracil/epirubicin/cyclophosphamide (FEC). Patients completed a health-related quality-of-life questionnaire at baseline, after one and four cycles of taxanes, before administration of FEC, and after administration of one and four cycles of FEC.Results: Thirty-six eligible patients were enrolled. The baseline characteristics of the two groups were well balanced. FACT-B scores at baseline andafter four cycles of taxanes were 115/108 (DTX/nab-PTX) and 99/92, respectively. There were no significant differences between DTX and nab-PTXfor FACT-B, FACT-B-Trial Outcome Index (FACT-B-TOI) and FACT-General. FACT-B and FACT-B TOI scores tended to decrease after one cycleand after four cycles of chemotherapy which did not recover to the baseline scores through the end of chemotherapy in each group.Conclusion: There were no significant safety differences between nab-PTX and DTX. HRQoL tended to decrease during taxane-based anticancertreatment, with no significant differences between the treatments. We suggest that the HRQoL questionnaire has limited ability to evaluate differentchemotherapy schedules. Trial registration UMIN000009855. Nov 20, 2012 registered.