白蛋白紫杉醇联合吉西他滨治疗老年与年轻转移性胰腺癌患者的比较：多中心、前瞻性、非干预性研究分析。
Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study.
机构信息
Medical University of Vienna, Department of Oncology, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Sankt Josef Krankenhaus, Internal Medicine 2, Auhofstraße 189, 1130, Vienna, Wien, Austria.
出版信息
Eur J Cancer. 2021 Jan;143:101-112. doi: 10.1016/j.ejca.2020.11.003. Epub 2020 Dec 6.
BACKGROUND
Pancreatic cancer (PC) ranks among the deadliest malignancies worldwide. In the MPACT study, first-line nab-paclitaxel plus gemcitabine (nab-P/G) demonstrated activity (median overall survival [OS], 8.7 months) and tolerability in patients with metastatic PC (mPC). However, the clinical evidence of nab-P/G in the elderly (>70 years), who account for the majority of patients with mPC, is limited. This is the first prospective, multicentre, non-interventional study evaluating the tolerability and effectiveness of nab-P/G in younger (≤70 years) versus elderly (>70 years) patients with mPC in the daily clinical routine.
METHODS
Eligible patients with mPC were treated with nab-P/G and observed until disease progression or unacceptable toxicity. The primary objectives were safety and tolerability of nab-P/G, and the secondary objectives were efficacy and real-life dosing.
RESULTS
A total of 317 patients with mPC (median age, 70 years) were recruited, of which 299, aged ≤70 (n = 162) and >70 (n = 137) years, were eligible for analysis. Baseline characteristics and the safety profile were comparable between the groups. However, fatigue (22.8% versus 13.0%) and decreased appetite (8.8% versus 1.2%) were more frequent in elderly patients. Younger versus elderly patients equally benefited in terms of objective response rate (36% versus 48%), median progression-free survival (5.6 versus 5.5 months; hazard ratio [HR] = 1.03; p = 0.81) and OS (10.6 versus 10.2 months; HR = 0.89; p = 0.4). In addition, the median treatment duration (5 versus 4 cycles), relative dose intensity (70% versus 74%) or reasons for treatment discontinuation were similar. Most patients (56.2% versus 47.4%) benefited from a second-line therapy.
CONCLUSION
This prospective real-world analysis confirms the feasibility and tolerability of nab-P/G treatment and reveals OS data similar for younger patients and elderly patients aged >70 years. CLINICALTRIALS.
GOV REGISTRATION
NCT02555813.
AUSTRIAN NIS REGISTRY
NIS005071.
背景
胰腺癌（PC）是全球最致命的恶性肿瘤之一。在 MPACT 研究中，一线nab-紫杉醇联合吉西他滨（nab-P/G）在转移性 PC（mPC）患者中显示出活性（中位总生存期[OS]为 8.7 个月）和可耐受性。然而，nab-P/G 在占 mPC 大多数患者的老年人（>70 岁）中的临床证据有限。这是第一项评估 nab-P/G 在年轻（≤70 岁）与老年（>70 岁）mPC 患者中的耐受性和有效性的前瞻性、多中心、非干预性研究，在日常临床实践中进行。
方法
符合条件的 mPC 患者接受 nab-P/G 治疗，并观察至疾病进展或不可接受的毒性。主要目的是评估 nab-P/G 的安全性和耐受性，次要目的是评估疗效和真实剂量。
结果
共招募了 317 名 mPC 患者（中位年龄为 70 岁），其中 299 名≤70 岁（n=162）和>70 岁（n=137）岁的患者符合分析条件。两组的基线特征和安全性概况相似。然而，老年患者更常出现疲劳（22.8%比 13.0%）和食欲下降（8.8%比 1.2%）。年轻与老年患者在客观缓解率（36%比 48%）、中位无进展生存期（5.6 比 5.5 个月；风险比[HR]1.03；p=0.81）和 OS（10.6 比 10.2 个月；HR=0.89；p=0.4）方面同样获益。此外，中位治疗持续时间（5 比 4 个周期）、相对剂量强度（70%比 74%）或治疗中断的原因相似。大多数患者（56.2%比 47.4%）受益于二线治疗。
结论
这项前瞻性真实世界分析证实了 nab-P/G 治疗的可行性和耐受性，并揭示了年轻患者和年龄>70 岁的老年患者的 OS 数据相似。临床试验。
政府注册
NCT02555813。
奥地利 NIS 注册：NIS005071。
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