Department of Hepato-Biliary-Pancreatic Medicine, Gastroenterology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Medical Oncology, Tochigi Cancer Center, Utsunomiya, Japan.
Eur J Cancer. 2023 Mar;181:135-144. doi: 10.1016/j.ejca.2022.12.014. Epub 2022 Dec 27.
We compared the efficacy of modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) with that of gemcitabine plus nab-paclitaxel (GnP) for locally advanced pancreatic cancer (LAPC).
Patients with untreated LAPC were randomly assigned (1:1) to receive mFOLFIRINOX or GnP. One-year overall survival (OS) was the primary endpoint. The major secondary end-points included progression-free survival (PFS), response rate (RR), carbohydrate antigen 19-9 (CA19-9) response, and adverse events. The sample size was 124 patients to select a more effective regimen with a minimum probability of 0.85 and to examine the null hypothesis of the 1-year OS <53%.
Of the 126 patients enrolled from 29 institutions, 125 were deemed eligible. The 1-year OS was 77.4% (95% CI, 64.9-86.0) and 82.5% (95% CI, 70.7-89.9) in the mFOLFIRINOX and GnP arms, respectively. The median PFS was 11.2 (95% CI, 9.9-15.9) and 9.4 months (95% CI, 7.4-12.8) in the mFOLFIRINOX and GnP arms, respectively. The RR and CA19-9 response rate were 30.9% (95% CI, 19.1-44.8) and 57.1% (95% CI, 41.0-72.3) and 42.1% (95% CI 29.1-55.9) and 85.0% (95% CI, 70.2-94.3) in the mFOLFIRINOX and GnP arms, respectively. Grade 3-4 diarrhoea and anorexia were predominant in the mFOLFIRINOX arm.
GnP was considered the candidate for a subsequent phase III trial because of its better RR, CA19-9 response, and mild gastrointestinal toxicities. Both regimens displayed higher efficacy in the 1-year survival than in the historical data of gemcitabine monotherapy.
我们比较了改良氟尿嘧啶、亚叶酸、伊立替康和奥沙利铂（mFOLFIRINOX）与吉西他滨加 nab-紫杉醇（GnP）治疗局部晚期胰腺癌（LAPC）的疗效。
未经治疗的 LAPC 患者被随机（1:1）分配接受 mFOLFIRINOX 或 GnP 治疗。主要终点为 1 年总生存率（OS）。主要次要终点包括无进展生存期（PFS）、缓解率（RR）、肿瘤标志物 19-9（CA19-9）反应和不良事件。样本量为 124 例，旨在选择一种更有效的治疗方案，其最小概率为 0.85，并检验 1 年 OS<53%的无效假设。
从 29 个机构共纳入 126 例患者，其中 125 例符合入组标准。mFOLFIRINOX 组和 GnP 组的 1 年 OS 分别为 77.4%（95%CI，64.9-86.0）和 82.5%（95%CI，70.7-89.9）。mFOLFIRINOX 组和 GnP 组的中位 PFS 分别为 11.2 个月（95%CI，9.9-15.9）和 9.4 个月（95%CI，7.4-12.8）。mFOLFIRINOX 组和 GnP 组的 RR 和 CA19-9 反应率分别为 30.9%（95%CI，19.1-44.8）和 57.1%（95%CI，41.0-72.3）和 42.1%（95%CI，29.1-55.9）和 85.0%（95%CI，70.2-94.3）。mFOLFIRINOX 组以 3-4 级腹泻和厌食为主。
由于 GnP 具有更高的 RR、CA19-9 反应率和较轻的胃肠道毒性，因此被认为是后续 III 期试验的候选药物。两种方案的 1 年生存率均高于吉西他滨单药治疗的历史数据。
