文章：

一线LV5FU2联合或不联合阿柏西普治疗不可切除转移性结直肠癌患者的随机II期临床试验（PRODIGE 25-FFCD-FOLFA）

First-Line LV5FU2 with or without Aflibercept in Patients with Non-Resectable Metastatic Colorectal Cancer: A Randomized Phase II Trial (PRODIGE 25-FFCD-FOLFA)

原文发布日期：16 April 2024

DOI: 10.3390/cancers16081515

类型: Article

开放获取: 是

英文摘要：

Fluropyrimidine monotherapy is an option for some patients with inoperable metastatic colorectal cancer. Unlike bevacizumab, the addition of aflibercept, an antibody acting as an anti-angiogenic agent, has never been evaluated in this context. The aim of the study was to determine whether aflibercept could increase the efficacy of fluoropyrimidine monotherapy without increasing toxicity. This multicenter phase II non-comparative trial evaluated the addition of aflibercept to infusional 5-fluorouracil/folinic acid (LV5FU2 regimen) as first-line treatment in patients unfit to receive doublet cytotoxic chemotherapy. The primary endpoint was 6-month progression-free survival (PFS). The clinical hypotheses expected a PFS rate at 6 months of over 40% (60% expected). A total of 117 patients, with a median age of 81 years, were included: 59 in arm A (LV5FU2-aflibercept) and 58 in arm B (LV5FU2 alone). Six-month PFS was 54.7% in both arms (90% CI 42.5–66.5 in both). Median overall survival was 21.8 months (arm A) and 25.1 months (arm B). Overall toxicity was more common in arm A: grade ≥ 3 toxicity in 82% versus 58.2%. Given the 6-month PFS, the study can be considered positive. However, the toxicity of aflibercept in this population was high, and continuation of the trial into phase III is not envisaged.

摘要翻译： 

氟尿嘧啶单药治疗是部分无法手术的转移性结直肠癌患者的一种选择。与贝伐珠单抗不同，作为抗血管生成药物的阿柏西普抗体在此背景下从未被评估过。本研究旨在确定阿柏西普是否能提高氟尿嘧啶单药治疗的疗效而不增加毒性。这项多中心II期非比较性试验评估了阿柏西普联合输注5-氟尿嘧啶/亚叶酸（LV5FU2方案）作为一线治疗，适用于不适合接受双药细胞毒性化疗的患者。主要终点是6个月无进展生存期（PFS）。临床假设预期6个月PFS率超过40%（预期为60%）。共纳入117例患者，中位年龄81岁：A组（LV5FU2-阿柏西普）59例，B组（单用LV5FU2）58例。两组6个月PFS均为54.7%（90% CI均为42.5-66.5）。中位总生存期分别为21.8个月（A组）和25.1个月（B组）。总体毒性在A组更常见：≥3级毒性发生率分别为82%和58.2%。鉴于6个月PFS结果，该研究可视为阳性。然而，阿柏西普在该人群中的毒性较高，因此不考虑将试验推进至III期。

原文链接：

First-Line LV5FU2 with or without Aflibercept in Patients with Non-Resectable Metastatic Colorectal Cancer: A Randomized Phase II Trial (PRODIGE 25-FFCD-FOLFA)