Pancreatic ductal adenocarcinoma (PAC) is a lethal disease with a devastating 5-year overall survival (OS) of approximately 7%. Although, just 4% of all malignant diseases are attributed to PAC, it is projected to become the second leading cause of cancer-related deaths in the United States before 2030.¹ Since the introduction of the new chemotherapy regimens including albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine and FOLFIRINOX, after the gemcitabine monotherapy era, survival of patients with PAC has improved.^2,3 This led to a change in the before rather theoretical debate about second-line treatment in the management of PAC and opened the clinical field for the exploration of continuum of care strategies. In 2015, there was the first approval of a second-line treatment option for patients with advanced PAC who have been previously treated with gemcitabine-based chemotherapy based upon the results of the phase III NAPOLI-1 trial.⁴ In this trial, 417 patients with metastatic PAC were randomized to three treatment arms and the combination treatment with nanoliposomal irinotecan (nal-IRI) and 5-fluorouracil/leucovorin (5-FU/LV) demonstrated superior survival compared with 5-FU/LV monotherapy (median OS of 6.1 versus 4.2 months; p = 0.012).

中文翻译：

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胰腺癌二线治疗方案的真实世界分析：脂质体-伊立替康加 5-氟尿嘧啶和亚叶酸

胰腺导管腺癌 (PAC) 是一种致命疾病，其 5 年总体生存率 (OS) 约为 7%。虽然只有 4% 的恶性疾病归因于 PAC，但预计 2030 年之前它将成为美国癌症相关死亡的第二大原因^。1自引入包括白蛋白结合型紫杉醇在内的新化疗方案以来（ nab-paclitaxel) 加吉西他滨和 FOLFIRINOX，在吉西他滨单药治疗时代之后，PAC 患者的生存率有所提高。^2,3这导致了之前关于 PAC 管理中二线治疗的理论争论发生了变化，并为探索连续护理策略开辟了临床领域。2015 年，根据 III 期 NAPOLI-1 试验的结果，首次批准了用于先前接受过基于吉西他滨化疗的晚期 PAC 患者的二线治疗方案。⁴在这项试验中，417 名转移性 PAC 患者被随机分配到三个治疗组，纳米脂质体伊立替康 (nal-IRI) 和 5-氟尿嘧啶/亚叶酸 (5-FU/LV) 的联合治疗与 5-FU/ LV 单药治疗（中位 OS 为 6.1与4.2 个月；p = 0.012）。