Elderly patients (pts) with MBC are under-represented in clinical studies and treatment is largely based on limited retrospective subgroup analyses. However, the 3 ESO-ESMO guidelines for Advanced Breast Cancer suggest that the management decisions should not be based on age alone.
This is an observational, retrospective, multicenter study conducted in 11 Oncology Sicilian Centers that evaluated safety and efficacy of nab-P in pts with HER2 negative MBC with age ≥ 65 years. We included 70 pts. Intrinsic molecular subtype: Luminal A (18.8%), Luminal B HER-2 negative (62.5%) and Triple negative (18.8%). The most common metastatic sites were: visceral plus bone (31.4%), bone (15.7%), lung (10%), visceral plus lymph nodes (10%). 33% of pts received nab-P as 4th line treatment. 87.1% of all pts received nab-P at doses 260 mg/m23-weekly and 12.9% received nab-P 125 mg/m2weekly. 28.6%, 25.7% and 26.2% of pts received previous treatment with taxanes in the neo-adjuvant and metastatic setting, respectively. Primary endpoint was safety of nab-P treatment. Secondary endpoints were overall response rate (ORR), progression free survival (PFS) and overall survival (OS).PFS and OS curves were estimated using the Kaplan-Meier method. ORR was defined as complete or partial response (CR+PR) according to RECIST 1.1 criteria. Adverse events (AEs) were assessed according to CTCAEv4.0.
Median (m) age of pts who received nab-P: 67 years (65-83). mECOG PS: 1 (range 0-2). The m cycles administrated was 6 (range 1-21). 35.5% of pts had a dose reduction and 11.5% of pts had treatment interruptions due to toxicity. The most frequent AEs were G2-3 and were observed in 47% of pts. The main toxicities were fatigue (61.5%), neuropathy (53.8%) and leukopenia (39.1%) and occurred in the 85.7% of pts treated with 3-weekly nab-P. ORR was 31.3% (CR in 6.3% and PR in 25% of pts). 39.1% of pts reported a stable disease. mPFS was 6 months (95% CI 2-38) and mOS was 40.5 months (95% CI 7-255).
Our real-life study showed that the treatment with nab-P is an effective and well-tolerated regimen in MBC elderly pts, even if previously treated with other taxanes. In particular, our data indicate that the weekly nab-P can be safely administered in elderly MBC pts.
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All authors have declared no conflicts of interest.