GV1001 联合吉西他滨/卡培他滨治疗血清嗜酸性粒细胞趋化因子水平高的初治晚期胰腺导管腺癌患者的疗效（KG4/2015）：一项开放标签、随机、3 期临床试验。

Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial.

机构信息

Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Br J Cancer. 2024 Jan;130(1):43-52. doi: 10.1038/s41416-023-02474-w. Epub 2023 Oct 30.

DOI:10.1038/s41416-023-02474-w

PMID:37903909

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10781743/

Abstract

BACKGROUND

The TeloVac study indicated GV1001 did not improve the survival of advanced pancreatic ductal adenocarcinoma (PDAC). However, the cytokine examinations suggested that high serum eotaxin levels may predict responses to GV1001. This Phase III trial assessed the efficacy of GV1001 with gemcitabine/capecitabine for eotaxin-high patients with untreated advanced PDAC.

METHODS

Patients recruited from 16 hospitals received gemcitabine (1000 mg/m, D 1, 8, and 15)/capecitabine (830 mg/m BID for 21 days) per month either with (GV1001 group) or without (control group) GV1001 (0.56 mg; D 1, 3, and 5, once on week 2-4, 6, then monthly thereafter) at random in a 1:1 ratio. The primary endpoint was overall survival (OS) and secondary end points included time to progression (TTP), objective response rate, and safety.

RESULTS

Total 148 patients were randomly assigned to the GV1001 (n = 75) and control groups (n = 73). The GV1001 group showed improved median OS (11.3 vs. 7.5 months, P = 0.021) and TTP (7.3 vs. 4.5 months, P = 0.021) compared to the control group. Grade >3 adverse events were reported in 77.3% and 73.1% in the GV1001 and control groups (P = 0.562), respectively.

CONCLUSIONS

GV1001 plus gemcitabine/capecitabine improved OS and TTP compared to gemcitabine/capecitabine alone in eotaxin-high patients with advanced PDAC.

CLINICAL TRIAL REGISTRATION

NCT02854072.

摘要

背景

TeloVac 研究表明 GV1001 并未改善晚期胰腺导管腺癌（PDAC）患者的生存。然而，细胞因子检测表明，血清嗜酸性粒细胞趋化因子水平较高可能预示着对 GV1001 的反应。本 III 期试验评估了 GV1001 联合吉西他滨/卡培他滨治疗未经治疗的晚期 PDAC 嗜酸性粒细胞趋化因子高患者的疗效。

方法

从 16 家医院招募的患者每月接受吉西他滨（1000mg/m2，D1、8 和 15）/卡培他滨（830mg/m2，bid，持续 21 天）治疗，随机分为 GV1001 组（0.56mg；D1、3 和 5，每 2-4 周一次，然后每月一次）和对照组（0.56mg；D1、3 和 5，每 2-4 周一次，然后每月一次）。主要终点是总生存期（OS），次要终点包括无进展生存期（TTP）、客观缓解率和安全性。

结果

共有 148 名患者被随机分配至 GV1001 组（n=75）和对照组（n=73）。GV1001 组中位 OS（11.3 个月 vs. 7.5 个月，P=0.021）和 TTP（7.3 个月 vs. 4.5 个月，P=0.021）均优于对照组。GV1001 组和对照组分别有 77.3%和 73.1%的患者发生≥3 级不良事件（P=0.562）。