Nab-Paclitaxel in Advanced HER2-ve Breast Cancer Patients: Efficacy and Safety Beyond Clinical Trials

Abstract Background Few data are available regarding efficacy and safety of Nab-Paclitaxel in advanced breast cancer patients outside a controlled trial, especially for the weekly schedule. Methods We prospectively collected data of advanced breast cancer patients candidate to be treated with weekly (125 mg/m2 for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m2 ) schedules of Nab-Paclitaxel, according to physician’s decision. Results The study enrolled 209 patients, of whom 92 (39.3%) cases received weekly Nab-Paclitaxel. Median age was 58 years (range: 31-84); 21.8% of the cases were classified as TNBC (ER-/PgR-). Median number of cycles was 5.5. Overall Response Rate was 32.1% in the whole population, without any significant difference according to schedule, previous Paclitaxel exposure, presence of visceral metastases or line of treatment. Median Time To Progression was 6 months (95%CI: 1-34), with no differences according to the schedule of treatment. Severe adverse events (Grade 3-4) were observed in 60.6% of the patients. Main toxicities were alopecia (53.4%), neutropenia (3%) and sensory neuropathy (2.1%). Conclusion Our real-life data indicate that both schedules of Nab-Paclitaxel, are manageable and safe in advanced breast cancer patients, even if previously treated with other taxanes.