Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
Modified Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin or S-1, Irinotecan, and Oxaliplatin Versus Nab-Paclitaxel + Gemcitabine in Metastatic or Recurrent Pancreatic Cancer (GENERATE, JCOG1611): A Randomized, Open-Label, Phase II/III Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
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Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and toxicities of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel as first-line chemotherapy for unresectable pancreatic cancer: a systematic review and meta-analysis.Frontiers in oncology · 2026Pooled it
- Pharmacogenomic profiling of the efficacy of gemcitabine monotherapy in metastatic pancreatic cancer: Subgroup analysis of the GENESECT study.British journal of clinical pharmacology · 2026Article
- NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: results from an open-label, phase II study.ESMO gastrointestinal oncology · 2026Article
- Long-term survival with multidisciplinary treatment including local and systemic treatment for germline BRCA2-positive pancreatic acinar cell carcinoma.Clinical journal of gastroenterology · 2026Article
- Association between response to gemcitabine-based neoadjuvant therapy and efficacy of gemcitabine plus nab-paclitaxel for recurrent pancreatic ductal adenocarcinoma.International journal of clinical oncology · 2026Article
- Determinants of eligibility for second-line chemotherapy following gemcitabine plus nab-paclitaxel therapy in patients with unresectable pancreatic cancer: a retrospective study.BMC gastroenterology · 2026Article
- Prognostic value of lactate dehydrogenase-to-albumin ratio in metastatic/recurrent pancreatic cancer treated with first-line gemcitabine plus nab-paclitaxel: a single-center retrospective cohort study.Journal of gastrointestinal oncology · 2026Article
- Optimization of first-line treatment selection in advanced pancreatic adenocarcinoma using artificial intelligence.NPJ precision oncology · 2026Article
- Efficacy and safety of National Centralized Drug Procurement-procured versus non-National Centralized Drug Procurement oxaliplatin in unresectable or metastatic pancreatic cancer: a retrospective cohort study.Translational cancer research · 2026Article
- Genomic Biomarkers for First-Line Treatment Selection in Metastatic Pancreatic Ductal Adenocarcinoma: A Narrative Review.Cancers · 2026Review
- FOLFIRINOX vs. Gemcitabine/Nab-Paclitaxel for Pancreatic Cancer by BRCA2 and TMB Status: A Japanese C-CAT Database Study.Cancer science · 2026Article
- Is FOLFIRINOX more effective than gemcitabine plus nab-paclitaxel in pancreatic adenocarcinoma? -a decade of debate!Journal of gastrointestinal oncology · 2026Article
- Review
- Comparative Proteomic Profiling of Responses to Standard Systemic Treatment Regimens in Pancreatic Cancer.Cells · 2026Article
- Article
- Cancer stem cell-driven drug resistance in colorectal carcinoma: molecular aspects and therapeutic potentials.Molecular cancer · 2026Review
- Article
- Comparative efficacy and safety of NALIRIFOX versus other first-line chemotherapy regimens in metastatic pancreatic ductal adenocarcinoma: a retrospective study.Therapeutic advances in medical oncology · 2026Article
- Treatment patterns and outcomes of patients with a diagnosis of metastatic pancreatic adenocarcinoma in the United States, 2019-2024.Frontiers in oncology · 2026Article
- A Case of Pancreatic Cancer Complicated by Active Pulmonary Tuberculosis Successfully Managed through a Multidisciplinary Treatment Strategy.Surgical case reports · 2026Article
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeModified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) and nab-paclitaxel + gemcitabine are recommended as first-line treatments for metastatic pancreatic cancer. S-1, irinotecan, and oxaliplatin (S-IROX) demonstrated activity in a phase Ib trial in this population. Therefore, these three regimens were directly compared.
methodsThis randomized phase II/III trial was performed at 45 centers in Japan. Eligible patients age 20-75 years with an Eastern Cooperative Oncology Group performance status of 0 or 1 and pathologically confirmed metastatic or recurrent pancreatic cancer were randomly assigned (1:1:1) to receive mFOLFIRINOX (oxaliplatin 85 mg/m
resultsA total of 527 patients were enrolled, with 426 included in the planned interim analysis. The median OS was 14.0 months (hazard ratio [HR], 1.31 [95% CI, 0.97 to 1.77]) and 13.6 months (HR, 1.35 [95% CI, 1.00 to 1.82]) in the mFOLFIRINOX and S-IROX groups, respectively, as compared with 17.1 months in the nab-paclitaxel + gemcitabine group. The predictive probability of achieving superiority in the final analysis was <1% in both groups. Thus, the trial was terminated owing to its futility. Grade 3 to 4 anorexia was more frequent in the mFOLFIRINOX (23.3%) and S-IROX (27.5%) groups than in the nab-paclitaxel + gemcitabine group (5.0%).
conclusionNeither mFOLFIRINOX nor S-IROX appeared to be superior compared with nab-paclitaxel + gemcitabine as the first-line treatment for metastatic or recurrent pancreatic cancer.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.