Brown Michael B, Blair Hannah A
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2025 Feb;85(2):255-262. doi: 10.1007/s40265-024-02133-1. Epub 2025 Jan 17.
Liposomal irinotecan (Onivyde), also known as liposomal pegylated irinotecan, has been developed with the intent of maximising anti-tumour efficacy and minimising drug-related toxicities compared with conventional formulations of this topoisomerase 1 inhibitor. In combination with fluorouracil, leucovorin and oxaliplatin (NALIRIFOX), liposomal irinotecan is approved in the USA and the EU for first-line therapy of eligible patients with metastatic pancreatic adenocarcinoma. In a phase III clinical trial, NALIRIFOX significantly improved overall survival (OS) and progression free survival (PFS) compared with gemcitabine plus nanoparticle albumin bound paclitaxel (nab-paclitaxel) as first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The safety profile of NALIRIFOX was generally manageable, with diarrhoea, hypokalaemia and neutropenia being the most common grade ≥ 3 treatment-emergent adverse events. Although further analyses will help position the liposomal irinotecan-containing regimen NALIRIFOX in first-line treatment of metastatic pancreatic adenocarcinoma, current evidence indicates that it is a useful addition to treatment options in this patient population.
脂质体伊立替康（Onivyde），也称为脂质体聚乙二醇化伊立替康，其研发目的是与这种拓扑异构酶1抑制剂的传统制剂相比，最大化抗肿瘤疗效并最小化药物相关毒性。脂质体伊立替康与氟尿嘧啶、亚叶酸钙和奥沙利铂联合使用（NALIRIFOX方案），在美国和欧盟被批准用于符合条件的转移性胰腺腺癌患者的一线治疗。在一项III期临床试验中，与吉西他滨加纳米白蛋白结合紫杉醇（nab-紫杉醇）作为转移性胰腺导管腺癌（mPDAC）患者的一线治疗相比，NALIRIFOX方案显著改善了总生存期（OS）和无进展生存期（PFS）。NALIRIFOX方案的安全性通常是可控的，腹泻、低钾血症和中性粒细胞减少是最常见的≥3级治疗中出现的不良事件。尽管进一步分析将有助于确定含脂质体伊立替康的NALIRIFOX方案在转移性胰腺腺癌一线治疗中的地位，但目前的证据表明，它是该患者群体治疗选择中的一个有用补充。
