Yamaguchi Kazuhisa, Kikuchi Yoshinori, Kimura Yusuke, Iwasaki Susumu, Takuma Kensuke, Okano Naoki, Matsuda Takahisa
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Omori Medical Center, Tokyo, Japan,
Department of Clinical Oncology, Faculty of Medicine, Toho University Omori Medical Center, Tokyo, Japan.
Oncology. 2024 Dec 20:1-11. doi: 10.1159/000543027.
Nanoliposomal irinotecan (nal-IRI) + 5-fluorouracil (FU)/leucovorin (LV) is the new standard second-line therapy for advanced pancreatic cancer (PC). Tegafur, gimeracil, and oteracil potassium (S-1) have been used in advanced PC after gemcitabine (GEM) plus nab-paclitaxel treatment, but the clinical difference between nal-IRI+5-FU/LV and S-1 remains unclear.
We retrospectively compared the efficacy and safety of nal-IRI+5-FU/LV and S-1 in patients with advanced PC refractory to GEM plus nab-paclitaxel. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.
We analyzed patients with advanced PC who were refractory to GEM plus nab-paclitaxel from May 2015 to January 2022 at our hospital. Twelve patients treated with nal-IRI+5-FU/LV and 51 patients treated with S-1 were included in this study. Comparing the nal-IRI+5-FU/LV and S-1 groups, the median PFS was 2.95 months versus 2.10 months (p = 0.658), respectively, and the median OS was 8.51 months versus 5.83 months (p = 0.763), respectively. The ORR and DCR were 8.3% and 2.0% (p = 0.347) and 58.3% and 49.0% (p = 0.750) for the nal-IRI+5-FU/LV and S-1 groups, respectively. There were no significant differences in adverse events between the two groups. In a subgroup analysis, patients under 65 years of age treated with S-1 had a significantly better median OS (HR, 3.46; 95% CI: 1.02-11.71, p = 0.046).
Nal-IRI+5-FU/LV and S-1 were equally effective and safe as second-line therapy for PC. However, the results suggest that S1 is an option for younger patients, especially those under 65 years.
纳米脂质体伊立替康（nal-IRI）+5-氟尿嘧啶（FU）/亚叶酸钙（LV）是晚期胰腺癌（PC）新的标准二线治疗方案。替吉奥（S-1）已被用于吉西他滨（GEM）联合白蛋白结合型紫杉醇治疗后的晚期PC，但nal-IRI+5-FU/LV与S-1之间的临床差异仍不清楚。
我们回顾性比较了nal-IRI+5-FU/LV和S-1在GEM联合白蛋白结合型紫杉醇治疗难治的晚期PC患者中的疗效和安全性。主要终点为无进展生存期（PFS）和总生存期（OS）。次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和安全性。
我们分析了2015年5月至2022年1月在我院接受GEM联合白蛋白结合型紫杉醇治疗难治的晚期PC患者。本研究纳入了12例接受nal-IRI+5-FU/LV治疗的患者和51例接受S-1治疗的患者。比较nal-IRI+5-FU/LV组和S-1组，中位PFS分别为2.95个月和2.10个月（p = 0.658），中位OS分别为8.51个月和5.83个月（p = 0.763）。nal-IRI+5-FU/LV组和S-1组的ORR分别为8.3%和2.0%（p = 0.347），DCR分别为58.3%和49.0%（p = 0.750）。两组不良事件无显著差异。在亚组分析中，接受S-1治疗的65岁以下患者的中位OS显著更好（HR，3.46；95%CI：1.02-11.71，p = 0.046）。
nal-IRI+5-FU/LV和S-1作为PC的二线治疗同样有效且安全。然而，结果表明S1是年轻患者的一种选择，尤其是65岁以下的患者。
