SLOG versus modified FOLFIRINOX as first-line treatment for advanced pancreatic cancer: A randomized phase II trial (TCOG T5217).
Journal
European journal of cancer (Oxford, England : 1990)
Journal Volume
235
Start Page
Article number 116229
ISSN
1879-0852
Date Issued
2026-02-25
Author(s)
Chiang, Nai-Jung
Su, Yung-Yeh
Ho, I-Wei
Bai, Li-Yuan
Li, Chung-Pin
Chen, Jen-Shi
Hsiao, Chin-Fu
Tsou, Hsiao-Hui
Chiu, Tai-Jan
Hsieh, Yao-Yu
Rau, Kun-Ming
Ho, Ching-Liang
Shan, Yan-Shen
Chen, Li-Tzong
Abstract
A multicenter, randomized phase II trial to compare two first-line triplet treatments for advanced pancreatic ductal adenocarcinoma (PDAC).
Patients with histologically confirmed advanced PDAC were randomized 1:1 to receive S-1/leucovorin plus oxaliplatin, and gemcitabine (SLOG) or modified FOLFIRINOX (mFOLFIRINOX). Tumor response was assessed every eight weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), safety and biomarker studies.
A total of 129 patients (65 SLOG, 64 mFOLFIRINOX) were enrolled. After a median follow-up of 37.7 months, no significant differences were observed between the SLOG and mFOLFIRINOX arms in median PFS (7.5 vs. 6.5 months; p = 0.88), median OS (12.9 vs. 12.1 months), or objective response rate (38.5 % vs. 26.6 %). HRD (homologous recombination deficiency) mutations were found in 14 of 108 profiled patients (12.9 %). Patients with HRD mutations had significantly longer median PFS (11.9 vs. 7.0 months; p = 0.008) and OS (17.7 vs. 11.7 months; p = 0.036). The safety profiles differed: grade 3/4 neutropenia was significantly less common with SLOG (15.4 % vs. 53.1 %; p < 0.001), while SLOG had more grade 3/4 non-hematological toxicities.
SLOG did not demonstrate superiority in PFS over mFOLFIRINOX, and mFOLFIRINOX therefore remains as one of the preferred first-line standards. Given its lower incidence of severe neutropenia and its convenience with oral S-1, SLOG may warrant further investigation in selected Asian patients with advanced PDAC.
Subjects
First-line therapy
Homologous recombination deficiency
MFOLFIRINOX
Pancreatic ductal adenocarcinoma
Randomized phase II trial
Type
journal article