Evidence map›Paper›PMID 41687160›Full record

Trial reportESMO open2026

NALIRIFOX versus nab-paclitaxel and gemcitabine in older patients with treatment-naive metastatic pancreatic cancer: a subgroup analysis of the pivotal NAPOLI 3 trial.

T Macarulla, R Pazo Cid, M S Womack, A Cubillo Gracian, A Zervoudakis, H Hatoum, V Chung, A Patel, A S Paulson, S Pant and 10 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2026. 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. Article
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

20 authors.

T MacarullaVall d'Hebron University Hospital, Barcelona; Vall d'Hebron Institute of Oncology (VHIO), Barcelona. Electronic address: tmacarulla@vhio.net.
R Pazo CidHospital Universitario Miguel Servet, Zaragoza, Spain.
M S WomackTennessee Oncology, PLLC/SCRI, Chattanooga, USA.
A Cubillo GracianCentro Integral Oncológico Clara Campal, Madrid, Spain.
A ZervoudakisMemorial Sloan Kettering Cancer Center, New York.
H HatoumDepartment of Medicine Hematology/Oncology, University of Oklahoma Health Sciences Center, Oklahoma City.
V ChungCity of Hope National Medical Center, Duarte.
A PatelFlorida Cancer Specialists Fort Myers, Fort Myers.
A S PaulsonTexas Oncology-Baylor Charles A Sammons Cancer Center, Dallas.
S PantMD Anderson Cancer Center, Houston, USA.
E M O'ReillyMemorial Sloan Kettering Cancer Center, New York.
R A HubnerThe Christie NHS Foundation Trust, Manchester; Division of Cancer Sciences, University of Manchester, Manchester, UK.
E Van CutsemUniversity Hospitals Gasthuisberg Leuven, KU Leuven, Leuven, Belgium.
T Bekaii-SaabMayo Clinic, Scottsdale.
L ZhangIpsen, Cambridge, USA.
J LiIpsen, Cambridge, USA.
H ChenIpsen, Cambridge, USA.
F MaxwellIpsen, London, UK.
Z A WainbergDepartment of Gastrointestinal Medical Oncology, University of California Los Angeles, Los Angeles, USA.
D MelisiUniversità degli studi di Verona, Verona; Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe phase III NAPOLI 3 trial established liposomal irinotecan in combination with 5-fluorouracil/leucovorin plus oxaliplatin (NALIRIFOX) as a superior first-line (1L) treatment option compared with gemcitabine plus nab-paclitaxel (Gem + NabP) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC), without imposing an upper age limit on enrollment. The current analysis of the NAPOLI 3 data investigated the potential impact of older age on the efficacy and safety of NALIRIFOX. PATIENTS AND

methodsAdults with previously untreated mPDAC were randomly assigned in a 1 : 1 ratio to receive NALIRIFOX or Gem + NabP. This post hoc analysis compared outcomes for patients aged ≥70 years versus <70 years. Endpoints included overall survival (OS), progression-free survival (PFS), and safety. No statistical comparison was carried out.

resultsOf the 770 patients in the NAPOLI 3 population, 553 were aged <70 years and 217 were aged ≥70 years. Median OS and median PFS with NALIRIFOX were 11.7 months and 7.4 months, respectively, in the <70 years subgroup (n = 275) and 10.0 months and 7.3 months, respectively, in the ≥70 years subgroup (n = 108). The benefit of NALIRIFOX versus Gem + NabP was preserved in the older versus younger subgroup. There was no evidence of increased treatment-related toxicity in the older (versus younger) subgroup.

conclusionsNALIRIFOX improved mPDAC survival versus Gem + NabP irrespective of patient age, with no signals for reduced tolerability in the older (versus younger) patients. The results provide reassurance that triplet therapy with NALIRIFOX is an efficacious and tolerable regimen in older treatment-naive patients with mPDAC who were fit enough for inclusion in NAPOLI 3, supporting consideration of its use as 1L therapy in this population.

Indexed as

AlbuminsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalDeoxycytidinePaclitaxelPancreatic NeoplasmsAgedFemaleFluorouracilGemcitabineHumansIrinotecanLeucovorinMaleMiddle AgedOxaliplatin130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineFluorouracilGemcitabineIrinotecanLeucovorinOxaliplatinPaclitaxelageliposomal irinotecanmPDACNALIRIFOXNAPOLI 3pancreatic ductal adenocarcinoma

Identifiers

PMID41687160
PMCPMC12925108

What OpenQuestion holds

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Registered trials

None linked

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.