Evidence map›Paper›PMID 39781240›Full record

ArticleTherapeutic advances in medical oncology2025

Real-world effectiveness and safety of second- or third-line pegylated liposomal irinotecan plus 5-fluorouracil and folinic acid in pancreatic ductal adenocarcinoma in Spain.

Rafael Álvarez-Gallego, Roberto Pazo-Cid, Borja López de San Vicente, Teresa Macarulla, Eva Martinez, Fernando Garicano, Irene Hernández, Monica Granja, Ismael Ghanem, Joaquina Martinez and 5 more

Abstract readCase Reports
In one paragraph

Article in Therapeutic advances in medical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
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

15 authors.

Rafael Álvarez-GallegoCentro Integral Oncológico Clara Campal HM CIOCC, Hospital Universitario HM Sanchinarro, C\ Oña Nº10, Madrid 28050, Spain.ORCID https://orcid.org/0000-0002-3167-8039
Roberto Pazo-CidHospital Universitario Miguel Servet, Zaragoza, Spain.
Borja López de San VicenteHospital Universitario de Basurto, Bilbao, Spain.
Teresa MacarullaVall d'Hebrón Institute of Oncology (VHIO), Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
Eva MartinezHospital Universitario Marques de Valdecilla, Santander, Spain.
Fernando GaricanoHospital de Galdakao-Usansolo, Galdakao, Spain.
Irene HernándezComplejo Hospitalario de Navarra, Pamplona, Spain.
Monica GranjaHospital Clínico San Carlos, Madrid, Spain.
Ismael GhanemHospital La Paz, Madrid, Spain.
Joaquina MartinezInstituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Hospital Universitario Virgen de las Nieves, Granada, Spain.
Paula RiberaHospital Universitario Parc Tauli, Sabadell, Barcelona, Spain.
Roberto DiazHospital Universitario y Politécnico La Fe, Valencia, Spain.
Jose Ignacio Martin ValadésHospital MD Anderson Cancer Center Madrid, Madrid, Spain.ORCID https://orcid.org/0000-0001-7720-8713
Maria Cristina AngelesHospital Universitario San Juan de Alicante, Sant Joan d'Alacant, Alicante, Spain.
Antonio CubilloCentro Integral Oncológico Clara Campal HM CIOCC, Hospital Universitario HM Sanchinarro, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treatment with pegylated nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (folinic acid; 5-FU/LV) has demonstrated remarkable efficacy for metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical trials. However, real-world data on the effectiveness of nal-IRI+5-FU/LV is heterogeneous and is lacking in Spain. To assess the effectiveness and safety of nal-IRI+5-FU/LV in real-life PDAC patients in Spain. A multicenter retrospective study was conducted. Patients aged ⩾18 years who had received at least one cycle of nal-IRI+5-FU/LV as second- or third-line therapy for PDAC were included. The primary endpoint was overall survival (OS) from nal-IRI+5-FU/LV treatment initiation and OS from the diagnosis of metastatic disease (metOS). Overall, 200 evaluable patients were included (⩾3 metastatic sites: 22%; liver/lung metastases: 71.5%/36.9%; and Eastern Cooperative Oncology Group 0-1: 87% at nal-IRI+5FU/LV treatment initiation). Patients received a median of four cycles of nal-IRI+5FU/LV for 2.8 months (range 1.4-7.2), and the treatment was received in the second line by 80% of the patients. The median OS was 7.2 months (6- and 12-month OS rates: 58.1% and 28.9%, respectively), with 27.2% of the patients achieving OS ⩾12 months. The median metOS was 17.5 months, with 30.2% of the patients experiencing metOS ⩾ 24 months. The median progression-free survival (PFS) was 3.7 months (6- and 12-month PFS rate: 37.6% and 15.3%, respectively). The disease control rate was 35.5%. The median CA 19-9 levels decreased by at least 50% in 28.2% of the cases during treatment. Overall, 36% of the patients experienced at least one grade 3-4 adverse event during treatment, the most common being diarrhea (42.6%) and asthenia (30.9%). This real-world study shows that treatment with nal-IRI+5-FU/LV for advanced or metastatic PDAC affords benefit in terms of survival, radiological and CA 19-9 response, and PFS comparable to that reported in the clinical trial setting with a manageable safety profile.

Indexed as

5-fluorouracil/folinic acid (5-FU/LV)metastasespancreatic cancerpegylated nanoliposomal irinotecan (nal-IRI)real world

Identifiers

PMID39781240
PMCPMC11707772

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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.