文章：

吉西他滨联合白蛋白结合型紫杉醇治疗后转移性胰腺癌患者二线疗法的疗效与安全性真实世界证据

Real-World Evidence of the Efficacy and Safety of Second-Line Therapy After Gemcitabine and Nab-Paclitaxel for Patients with Metastatic Pancreatic Cancer

原文发布日期：28 August 2025

DOI: 10.3390/cancers17172821

类型: Article

开放获取: 是

英文摘要：

Background:Metastatic pancreatic cancer (mPC) is an aggressive disease with high morbidity and mortality, and long-term survival rates remain poor. New therapeutic options that demonstrate statistically significant improvements in overall survival (OS) and progression-free survival (PFS) are still being sought. Although many first-line (FL) treatment studies exist in the literature, there are almost no prospective studies on second-line (SL) therapy.Methods:The aim of this clinical study was to retrospectively analyze the medical history of 251 patients diagnosed with mPC, treated first-line (FL) with GEM-NAB between February 2017 and January 2025. After disease progression, 109 patients received SL treatment. We also present a multivariate analysis based on routinely collected data (demographic, clinical, and laboratory parameters) evaluating their impact on OS and PFS.Results:The median age was 66 years (range 37–84 years). The median PFS was 2.33 months (95% CI 1.69–2.97). Specifically, the mPFS was 4.1 months (95% CI 1.31–6.90) for FOLFIRINOX; 2.8 months (95% CI 2.30–3.30) for FOLFIRI; 2.37 months (95% CI 1.66–3.08) for NALIRI; 1.47 months (95% CI 1.18–1.75) for FOLFOX 6; and 0.93 months (95% CI 0.00–2.64) for GEM-cisplatin. The median OS was 5.03 months (95% CI 3.75–6.31). Seven patients achieved a partial response (overall response rate 6%). The most frequent adverse events (AEs) included anemia, fatigue, peripheral neuropathy, neutropenia, and thrombocytopenia.Conclusions:As a result, SL treatments were compared, and some statistically significant difference was found between them in PFS time for chemotherapy FOLFIRINOX and GEM + cisplatin. The most frequent AEs occurred during treatment with FOLFIRINOX chemotherapy.

摘要翻译： 

背景：转移性胰腺癌（mPC）是一种侵袭性强、发病率和死亡率均高的疾病，长期生存率仍然很低。目前仍在寻求能够显著改善总生存期（OS）和无进展生存期（PFS）的新治疗方案。尽管文献中存在许多一线（FL）治疗研究，但关于二线（SL）治疗的前瞻性研究几乎空白。 方法：本临床研究旨在回顾性分析2017年2月至2025年1月期间接受GEM-NAB一线治疗的251例mPC患者的病史。疾病进展后，109例患者接受了二线治疗。我们还基于常规收集的数据（人口统计学、临床和实验室参数）进行了多变量分析，评估这些因素对OS和PFS的影响。 结果：患者中位年龄为66岁（范围37-84岁）。中位PFS为2.33个月（95% CI 1.69-2.97）。具体而言，FOLFIRINOX方案的中位PFS为4.1个月（95% CI 1.31-6.90）；FOLFIRI方案为2.8个月（95% CI 2.30-3.30）；NALIRI方案为2.37个月（95% CI 1.66-3.08）；FOLFOX6方案为1.47个月（95% CI 1.18-1.75）；GEM-顺铂方案为0.93个月（95% CI 0.00-2.64）。中位OS为5.03个月（95% CI 3.75-6.31）。7例患者达到部分缓解（总缓解率6%）。最常见的不良事件包括贫血、疲劳、周围神经病变、中性粒细胞减少和血小板减少。 结论：通过比较不同二线治疗方案，发现FOLFIRINOX化疗与GEM+顺铂方案在PFS时间上存在统计学显著差异。最常见的不良事件发生在FOLFIRINOX化疗期间。

原文链接：

Real-World Evidence of the Efficacy and Safety of Second-Line Therapy After Gemcitabine and Nab-Paclitaxel for Patients with Metastatic Pancreatic Cancer