Potthoff Karin, Stötzer Oliver, Söling Ulrike, Hansen Richard, Harde Johanna, Dille Stephanie, Nusch Arnd, Marschner Norbert
Medical Department, iOMEDICO, Freiburg, Germany.
Medizinisches Zentrum für Hämatologie und Onkologie MVZ GmbH, München, Germany.
Clin Breast Cancer. 2020 Jun;20(3):e315-e326. doi: 10.1016/j.clbc.2019.11.003. Epub 2020 Mar 10.
There are only scarce data on treatment of elderly patients with nab-paclitaxel for metastatic breast cancer, especially from the real-world setting. Here we present data from the noninterventional study NABUCCO with special focus on taxane-induced peripheral neuropathy (TIPN) in younger and elderly patients.
A total of 407 patients with HR-positive/HER2-negative metastatic breast cancer were enrolled between April 2012 and April 2015 into the prospective, multicenter, noninterventional study NABUCCO. Details on effectiveness, tolerability, and safety of nab-paclitaxel were evaluated for younger (<70 years) and elderly (≥70 years) patients.
Neither median time to progression (TTP, younger 6.0 months, 95% confidence interval [CI], 5.5-7.1; elderly 6.9 months, 95% CI, 5.5-8.6) nor median overall survival (younger 16.4 months, 95% CI, 14.2-18.1; elderly 14.5 months, 95% CI, 11.9-17.4) differed by age group, also not in view of prior treatments. A multivariate regression model revealed that age did not significantly influence the TTP. TIPN was reported by 49.0% younger (44.3% common terminology criteria for adverse events [CTCAE] grade 1/2, 4.7% grade 3/4) and 45.8% elderly patients (41.1% CTCAE grade 1/2, 4.7% grade 3/4). The cumulative nab-paclitaxel dose did not correlate with the severity/grading of TIPN.
Treatment with nab-paclitaxel in first- or further-line of metastatic HR-positive/HER2-negative breast cancer resulted in similar effectiveness and safety, irrespective of age. Therefore, nab-paclitaxel is a valid treatment option for elderly and partially heavily pretreated patients. However, incidence of TIPN is high, influencing the patients' quality of life. A close monitoring and awareness for early TIPN symptoms is warranted.
关于老年转移性乳腺癌患者使用纳米白蛋白结合型紫杉醇治疗的数据非常稀少，尤其是来自真实世界的数据。在此，我们展示非干预性研究NABUCCO的数据，特别关注年轻和老年患者中紫杉烷引起的周围神经病变（TIPN）。
2012年4月至2015年4月期间，共有407例HR阳性/HER2阴性转移性乳腺癌患者纳入前瞻性、多中心、非干预性研究NABUCCO。对纳米白蛋白结合型紫杉醇的有效性、耐受性和安全性进行了评估，比较了年轻（<70岁）和老年（≥70岁）患者。
年龄组之间的中位疾病进展时间（TTP，年轻患者为6.0个月，95%置信区间[CI]为5.5-7.1；老年患者为6.9个月，95%CI为5.5-8.6）和中位总生存期（年轻患者为16.4个月，95%CI为14.2-18.1；老年患者为14.5个月，95%CI为11.9-17.4）均无差异，既往治疗情况也不影响上述结果。多变量回归模型显示，年龄对TTP无显著影响。49.0%的年轻患者报告发生了TIPN（44.3%为1/2级不良事件通用术语标准[CTCAE]，4.7%为3/4级），老年患者的这一比例为45.8%（41.1%为CTCAE 1/2级，4.7%为3/4级）。纳米白蛋白结合型紫杉醇的累积剂量与TIPN的严重程度/分级无关。
在转移性HR阳性/HER2阴性乳腺癌的一线或后续治疗中，使用纳米白蛋白结合型紫杉醇治疗的有效性和安全性相似，与年龄无关。因此，纳米白蛋白结合型紫杉醇是老年患者和部分经过大量预处理患者的有效治疗选择。然而，TIPN的发生率较高，影响患者生活质量。有必要密切监测并关注TIPN的早期症状。
