Background: Older women represent a significant and increasing population of patients with breast cancer, accounting for over 40% of new cases of breast cancer. However, this growing subgroup of patients is still underrepresented in clinical trials, and treatment is usually selected based on limited data from retrospective subgroup analyses. However, the ESMO guidelines for metastatic breast cancer (mBC) suggest that the management decision should not be based on age alone. Nab-paclitaxel (nab-P) was associated with improved efficacy and a better safety profile than solvent-based taxanes without steroid or antihistamine premedication, making this treatment appealing to elderly patients.Patients and methods: This is an observational, retrospective, multicenter study, evaluating the safety and activity of nab-paclitaxel (nab-P) in elderly patients (≥65 years old) with HER2-negative mBC from 11 Sicilian oncology centers. The primary endpoint of the study was the safety nab-P in elderly mBC patients; secondary endpoints included the overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).Results: We included 70 patients, and all were evaluable for safety and efficacy. All patients had previously been pretreated with taxane-based chemotherapy in a (neo)-adjuvant or metastatic setting. One third of the patients received nab-P as a fourth line therapy. Most of the patients were treated with nab-P at doses of 260 mg/m23-weekly (87.1%), and 12.9% received a nab-P dose of 125 mg/m2weekly. Patients’ characteristics included a median age of 67 years (range 65–83 years), a median ECOG PS of 1 (range 0–2), and the following intrinsic molecular subtypes: Luminal A (18.8%), Luminal B HER-2 negative (62.5%), and triple negative (18.8%). Nab-P was administered for a median of six cycles (range 1–21), with 35.5% of patients experiencing a dose reduction, and 11.5% treatment discontinuation due to toxicity. Adverse events were mainly G2-G3 and occurred mostly in patients treated with 3-weekly nab-P (85.7%). The ORR was 31.3% (CR in 6.3% and PR in 25% of pts) and the DCR was 70.4%. Median PFS was 6 months (95% CI, 2–38), and median OS was 40.5 months (95% CI, 7–255).Conclusions: Our real-life study showed that nab-P is an effective, well-tolerated regimen in elderly mBC patients, including taxane-pretreated patients, and can be safely administered in elderly mBC patients.
背景：老年女性在乳腺癌患者中构成重要且不断增长的人群，占新发乳腺癌病例的40%以上。然而，这一日益扩大的患者亚群在临床试验中的代表性仍然不足，治疗方案通常基于回顾性亚组分析的有限数据选择。但欧洲肿瘤内科学会（ESMO）转移性乳腺癌（mBC）指南指出，治疗决策不应仅基于年龄因素。相较于需使用类固醇或抗组胺药物预处理的溶剂型紫杉醇类药物，白蛋白结合型紫杉醇（nab-P）显示出更优的疗效和更好的安全性特征，使其对老年患者具有吸引力。 患者与方法：本研究为一项观察性、回顾性、多中心研究，评估了来自西西里岛11个肿瘤中心的HER2阴性mBC老年患者（≥65岁）使用白蛋白结合型紫杉醇（nab-P）的安全性和活性。研究主要终点为老年mBC患者使用nab-P的安全性；次要终点包括总缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。 结果：我们纳入了70例患者，所有患者均进行了安全性和疗效评估。所有患者既往均在新辅助/辅助或转移阶段接受过紫杉烷类化疗。三分之一的患者将nab-P作为四线治疗方案。大多数患者接受每3周260 mg/m²剂量的nab-P治疗（87.1%），12.9%的患者接受每周125 mg/m²剂量治疗。患者特征包括：中位年龄67岁（范围65-83岁），中位ECOG PS评分为1分（范围0-2分），分子亚型分布为：Luminal A型（18.8%）、Luminal B型HER-2阴性（62.5%）和三阴性（18.8%）。患者接受nab-P治疗的中位周期数为6个周期（范围1-21），35.5%的患者出现剂量降低，11.5%的患者因毒性反应终止治疗。不良事件主要为2-3级，且主要发生在接受3周方案治疗的患者中（85.7%）。总缓解率为31.3%（完全缓解率6.3%，部分缓解率25%），疾病控制率为70.4%。中位无进展生存期为6个月（95% CI，2-38），中位总生存期为40.5个月（95% CI，7-255）。 结论：我们的真实世界研究表明，对于老年mBC患者（包括既往接受过紫杉烷类治疗的患者），nab-P是一种有效且耐受性良好的治疗方案，可在老年mBC患者中安全使用。
肿瘤(癌症)患者之家