Ricciardi Giuseppina Rosaria Rita, Russo Alessandro, Sanò Maria Vita, Prestifilippo Angela, Russo Antonio, Gebbia Vittorio, Blasi Livio, Giuffrida Dario, Scandurra Giuseppa, Savarino Antonio, Butera Alfredo, Borsellino Nicolò, Verderame Francesco, Caruso Michele, Adamo Vincenzo
Department of Onco-Hematology, Papardo Hospital, 98158 Messina, Italy.
Department of Medical Oncology, Humanitas Istituto Clinico Catanese, 95045 Catania, Italy.
Cancers (Basel). 2025 Jun 20;17(13):2069. doi: 10.3390/cancers17132069.
: 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. : 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). : 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/m 3-weekly (87.1%), and 12.9% received a nab-P dose of 125 mg/m weekly. 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). : 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.
老年女性是乳腺癌患者中数量可观且不断增加的群体，占乳腺癌新发病例的40%以上。然而，这一不断增长的患者亚组在临床试验中的代表性仍然不足，治疗通常是基于回顾性亚组分析的有限数据来选择。不过，欧洲肿瘤内科学会（ESMO）的转移性乳腺癌（mBC）指南指出，治疗决策不应仅基于年龄。与需使用类固醇或抗组胺药进行预处理的溶剂型紫杉烷类药物相比，纳米白蛋白结合型紫杉醇（nab-P）具有更高的疗效和更好的安全性，这使得该治疗方法对老年患者具有吸引力。
这是一项观察性、回顾性、多中心研究，评估纳米白蛋白结合型紫杉醇（nab-P）在来自11个西西里岛肿瘤中心的HER2阴性mBC老年患者（≥65岁）中的安全性和活性。该研究的主要终点是nab-P在老年mBC患者中的安全性；次要终点包括总缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。
我们纳入了70例患者，所有患者均可进行安全性和疗效评估。所有患者之前均在（新）辅助或转移性治疗中接受过基于紫杉烷的化疗。三分之一的患者将nab-P作为四线治疗。大多数患者接受的nab-P剂量为260 mg/m²，每周一次（87.1%），12.9%的患者接受的nab-P剂量为125 mg/m²，每周一次。患者的特征包括中位年龄67岁（范围65 - 83岁），中位东部肿瘤协作组（ECOG）体能状态评分为1（范围0 - 2），以及以下内在分子亚型：管腔A型（18.8%）、管腔B型HER-2阴性（62.5%）和三阴性（18.8%）。nab-P的中位给药周期为6个周期（范围1 - 21），35.5%的患者出现剂量减少，11.5%的患者因毒性而停药。不良事件主要为2 - 3级，大多发生在接受每周一次nab-P治疗的患者中（85.7%）。ORR为31.3%（完全缓解率为6.3%，部分缓解率为25%），疾病控制率（DCR）为70.4%。中位PFS为6个月（95%置信区间，2 - 38），中位OS为40.5个月（95%置信区间，7 - 255）。
我们的真实世界研究表明，nab-P在老年mBC患者中是一种有效且耐受性良好的治疗方案，包括接受过紫杉烷预处理的患者，并且可以在老年mBC患者中安全给药。
