Evidence map›Paper›PMID 31357748›Full record

ArticleCancers2019

Nomogram for Predicting Survival in Patients Treated with Liposomal Irinotecan Plus Fluorouracil and Leucovorin in Metastatic Pancreatic Cancer.

Li-Tzong Chen, Teresa Macarulla, Jean-Frédéric Blanc, Beloo Mirakhur, Floris A de Jong, Bruce Belanger, Tanios Bekaii-Saab, Jens T Siveke

Registry-linked trialAbstract read
In one paragraph

Article in Cancers, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01494506 (A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing 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.

NCT01494506 phase3completednot on this map

A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy

TypeinterventionalSponsorMerrimack PharmaceuticalsRan2011 to 2015Enrolled417ConditionsMetastatic Pancreatic CancerArmsMM-398, 5 Fluorouracil, Leucovorin
3 · Its place in the literature

Who cites it

25 citing papers in PubMed.

  1. Trial
  2. Observational
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  5. Review
  6. Article
  7. Observational
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  20. 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

8 authors.

Li-Tzong ChenNational Institute of Cancer Research, National Health Research Institutes, 704 Tainan, Taiwan. leochen@nhri.org.tw.
Teresa MacarullaVall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, 08035 Barcelona, Spain.
Jean-Frédéric BlancGroupe Hospitalier Haut-Lévêque, CHU Bordeaux, 33600 Pessac, France.
Beloo MirakhurIpsen Biopharmaceuticals, Inc., Basking Ridge, NJ 07920, USA.
Floris A de JongGlobal Medical Affiars, Servier, 8002 Zürich, Switzerland.
Bruce BelangerIpsen Biopharmaceuticals, Inc., Cambridge, MA 02142, USA.
Tanios Bekaii-SaabMayo Clinic Cancer Center, Phoenix, AZ 85054, USA.
Jens T SivekeGerman Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany.

Funding

Ipsen Biopharmaceuticals N/AMerrimack Pharmaceuticals, Inc N/A
6 · The paper itself

Abstract

NAPOLI-1 (NCT01494506) was a phase III study of liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. This post hoc analysis of NAPOLI-1 aimed to develop a predictive nomogram for overall survival (OS) at 6 and 12 months. Analyses were derived from all patients in NAPOLI-1 randomized to receive nal-IRI+5-FU/LV, nal-IRI monotherapy, or 5-FU/LV combination therapy. OS was associated with baseline factors using univariate and multivariable Cox analyses. A predictive nomogram was derived and validated using a concordance index and calibration plots. The univariate analyses identified 21 independent factors that contributed to OS, with eight factors significantly associated with OS. The Karnofsky Performance Score contributed the largest number of points (100), followed by presence of liver metastasis (98) and randomization to nal-IRI+5-FU/LV (96). The other baseline factors showing effects were albumin (g/dL), neutrophil/lymphocyte ratio, carbohydrate antigen 19-9 (U/mL), disease stage at diagnosis, and body mass index (kg/m

Indexed as

liposomal irinotecanNAPOLI-1nomogrampancreatic cancersurvival outcomes

Identifiers

PMID31357748
PMCPMC6721419

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.