Álvarez-Gallego Rafael, Pazo-Cid Roberto, López de San Vicente Borja, Macarulla Teresa, Martinez Eva, Garicano Fernando, Hernández Irene, Granja Monica, Ghanem Ismael, Martinez Joaquina, Ribera Paula, Diaz Roberto, Martin Valadés Jose Ignacio, Angeles Maria Cristina, Cubillo Antonio
Centro Integral Oncológico Clara Campal HM CIOCC, Hospital Universitario HM Sanchinarro, C\ Oña Nº10, Madrid 28050, Spain.
Facultad HM Hospitales de Ciencias de la Salud, Universidad Camilo José Cela (UCJC), Madrid, Spain.
Ther Adv Med Oncol. 2025 Jan 8;17:17588359241309828. doi: 10.1177/17588359241309828. eCollection 2025.
Treatment with pegylated nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (folinic acid; 5-FU/LV) has demonstrated remarkable efficacy for metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical trials. However, real-world data on the effectiveness of nal-IRI+5-FU/LV is heterogeneous and is lacking in Spain. To assess the effectiveness and safety of nal-IRI+5-FU/LV in real-life PDAC patients in Spain. A multicenter retrospective study was conducted. Patients aged ⩾18 years who had received at least one cycle of nal-IRI+5-FU/LV as second- or third-line therapy for PDAC were included. The primary endpoint was overall survival (OS) from nal-IRI+5-FU/LV treatment initiation and OS from the diagnosis of metastatic disease (metOS). Overall, 200 evaluable patients were included (⩾3 metastatic sites: 22%; liver/lung metastases: 71.5%/36.9%; and Eastern Cooperative Oncology Group 0-1: 87% at nal-IRI+5FU/LV treatment initiation). Patients received a median of four cycles of nal-IRI+5FU/LV for 2.8 months (range 1.4-7.2), and the treatment was received in the second line by 80% of the patients. The median OS was 7.2 months (6- and 12-month OS rates: 58.1% and 28.9%, respectively), with 27.2% of the patients achieving OS ⩾12 months. The median metOS was 17.5 months, with 30.2% of the patients experiencing metOS ⩾ 24 months. The median progression-free survival (PFS) was 3.7 months (6- and 12-month PFS rate: 37.6% and 15.3%, respectively). The disease control rate was 35.5%. The median CA 19-9 levels decreased by at least 50% in 28.2% of the cases during treatment. Overall, 36% of the patients experienced at least one grade 3-4 adverse event during treatment, the most common being diarrhea (42.6%) and asthenia (30.9%). This real-world study shows that treatment with nal-IRI+5-FU/LV for advanced or metastatic PDAC affords benefit in terms of survival, radiological and CA 19-9 response, and PFS comparable to that reported in the clinical trial setting with a manageable safety profile.
聚乙二醇化纳米脂质体伊立替康（nal-IRI）联合5-氟尿嘧啶/亚叶酸（甲酰四氢叶酸；5-FU/LV）治疗在临床试验中已显示出对转移性胰腺导管腺癌（PDAC）具有显著疗效。然而，关于nal-IRI+5-FU/LV有效性的真实世界数据存在异质性，且西班牙缺乏相关数据。为评估nal-IRI+5-FU/LV在西班牙现实生活中的PDAC患者中的有效性和安全性。进行了一项多中心回顾性研究。纳入年龄≥18岁、接受至少一个周期nal-IRI+5-FU/LV作为PDAC二线或三线治疗的患者。主要终点是从开始使用nal-IRI+5-FU/LV治疗起的总生存期（OS）以及从诊断为转移性疾病起的总生存期（metOS）。总体而言，纳入了200例可评估患者（≥3个转移部位：22%；肝/肺转移：71.5%/36.9%；在开始使用nal-IRI+5FU/LV治疗时东部肿瘤协作组0-1：87%）。患者接受nal-IRI+5FU/LV的中位周期数为4个周期，持续2.8个月（范围1.4 - 7.2），80%的患者在二线接受该治疗。中位OS为7.2个月（6个月和12个月OS率分别为58.1%和28.9%），27.2%的患者OS≥12个月。中位metOS为17.5个月?，30.2%的患者metOS≥24个月。中位无进展生存期（PFS）为3.7个月（6个月和12个月PFS率分别为37.6%和15.3%）。疾病控制率为35.5%。治疗期间28.2%的病例中CA 19-9水平中位数至少下降50%。总体而言，36%的患者在治疗期间经历至少一次3 - 4级不良事件，最常见的是腹泻（42.6%）和乏力（30.9%）。这项真实世界研究表明，使用nal-IRI+5-FU/LV治疗晚期或转移性PDAC在生存、影像学和CA 19-9反应以及PFS方面具有益处，与临床试验中报告的情况相当，且安全性可控。
