Evidence map›Paper›PMID 41205353›Full record

ArticleESMO open2025

Second-line 5-FU plus nanoliposomal irinotecan versus FOLFOX/XELOX in metastatic pancreatic cancer after gemcitabine-nab-paclitaxel failure: a propensity score-matched analysis.

G Trovato, D Rossini, A Guidolin, Y-Y Su, Y-S Shan, N-J Chiang, W-C Chou, L-Y Bai, C Bagalà, M Bensi and 14 more

Abstract readComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

G TrovatoMedical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli-IRCCS, Rome, Italy; Medical Oncology Unit, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: giovanni.trovato@guest.policlinicogemelli.it.
D RossiniDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Oncology Unit, Careggi University Hospital, Florence, Italy.
A GuidolinDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Oncology Unit, Careggi University Hospital, Florence, Italy.
Y-Y SuDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Italy; National Institute of Cancer Research, National Health Research Institutes, Tainan, Italy; Department of Internal Medicine, Kaohsiung Medical University Hospital, and Center for Cancer Research, Kaohsiung Medical University, Kaohsiung, Italy.
Y-S ShanDepartment of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Italy.
N-J ChiangDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Italy; School of Medicine, National Yang Ming Chiao Tung University, Taipei, Italy.
W-C ChouDepartment of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Chang Gung University College of Medicine, Taoyuan, Taiwan.
L-Y BaiInternal Medicine, College of Medicine, China Medical University, Taichung, Taiwan; Division of Hematology and Oncology, China Medical University Hospital, China Medical University, Taichung, Taiwan.
C BagalàMedical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli-IRCCS, Rome, Italy.
M BensiMedical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli-IRCCS, Rome, Italy.
M NigerDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
S MarchesiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
S K GarattiniMedical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.
A MichelottiMedical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.
A PrettaMedical Oncology, University Hospital, Cagliari, Italy.
M ScartozziMedical Oncology, University Hospital, Cagliari, Italy.
C VivaldiUnit of Medical Oncology 2, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy; Department of Translational Medicine Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
L BartaliniUnit of Medical Oncology 2, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy; Department of Translational Medicine Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
L ProcaccioMedical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
F BergamoMedical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
L AntonuzzoDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Oncology Unit, Careggi University Hospital, Florence, Italy.
L-T ChenDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Italy; National Institute of Cancer Research, National Health Research Institutes, Tainan, Italy; Department of Internal Medicine, Kaohsiung Medical University Hospital, and Center for Cancer Research, Kaohsiung Medical University, Kaohsiung, Italy.
L SalvatoreMedical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli-IRCCS, Rome, Italy; Medical Oncology Unit, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: https://twitter.com/LisaSalvy.
G TortoraMedical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli-IRCCS, Rome, Italy; Medical Oncology Unit, Università Cattolica del Sacro Cuore, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is limited evidence comparing second-line therapies following gemcitabine plus nab-paclitaxel (GemNab) in metastatic pancreatic ductal adenocarcinoma (PDAC). This study aimed to compare the effectiveness and safety of 5-fluorouracil plus nanoliposomal irinotecan (5-FU + Nal-IRI) versus oxaliplatin-based regimens (FOLFOX/XELOX) in this setting. PATIENTS AND

methodsWe retrospectively analyzed 445 patients with metastatic PDAC progressing after first-line GemNab, treated across 12 centers in Italy and Asia (2014-2024). Patients received either 5-FU + Nal-IRI (n = 180) or FOLFOX/XELOX (n = 265) as second-line therapy. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and safety. Exact propensity score matching was carried out to reduce baseline imbalances.

resultsIn the matched cohort, median OS was 7.2 months [95% confidence interval (CI) 5.8-8.4 months] for 5-FU + Nal-IRI and 5.8 months (95% CI 4.1-6.8 months) for FOLFOX/XELOX [hazard ratio (HR) 0.74, 95% CI 0.58-0.95, P = 0.015], and median PFS was 3.0 months (95% CI 2.5-3.6 months) versus 2.5 months (95% CI 2.2-2.9 months), respectively (HR 0.75, 95% CI 0.61-0.91, P = 0.0048). ORR was similar (9% versus 10%, P = 0.79). Grade 3-4 adverse events were more frequent with 5-FU + Nal-IRI (31.1% versus 9.4%), particularly anemia (13.9% versus 1.7%) and diarrhea (5.6% versus 1.2%). FOLFOX/XELOX was associated with higher rates of any-grade thrombocytopenia and peripheral neuropathy.

conclusions5-FU + Nal-IRI showed a modest yet statistically significant survival advantage compared with FOLFOX/XELOX in patients with metastatic PDAC previously treated with GemNab, despite being associated with a higher incidence of adverse events. None the less, the selection of second-line therapy should be guided by a balanced evaluation of both efficacy and toxicity profiles.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsIrinotecanPancreatic NeoplasmsAdultAgedAlbuminsCapecitabineDeoxycytidineFemaleFluorouracilGemcitabineHumansLeucovorinMaleMiddle AgedOrganoplatinum Compounds130-nm albumin-bound paclitaxelAlbuminsCapecitabineDeoxycytidineFluorouracilGemcitabineIrinotecanLeucovorinOrganoplatinum CompoundsOxaloacetatesPaclitaxelnanoliposomal irinotecanoxaliplatinpancreatic cancersecond-line therapy

Identifiers

PMID41205353
PMCPMC12639605

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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.