Evidence map›Paper›PMID 27765912›Full record

Trial reportOncotarget2016

An assessment of the benefit-risk balance of FOLFIRINOX in metastatic pancreatic adenocarcinoma.

Julien Péron, Pascal Roy, Thierry Conroy, Françoise Desseigne, Marc Ychou, Sophie Gourgou-Bourgade, Trevor Stanbury, Laurent Roche, Brice Ozenne, Marc Buyse

Open access · diamondAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.4field-weighted citation impact, top 16% of its field
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

7 citing papers in PubMed, 27 citations in OpenAlex.

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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

10 authors at 7 institutions in 1 country.

Julien PéronCNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Service de Biostatistiques, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, 69495 Pierre-Bénite, France.
Pascal RoyCNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Service de Biostatistiques, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, 69495 Pierre-Bénite, France.
Thierry ConroyInstitut de Cancérologie de Lorraine, Alexis Vautrin Center, 54500 Vandœuvre-lès-Nancy, France.
Françoise DesseigneMedical Oncology Department, Centre Léon Bérard, 69373 Lyon, France.
Marc YchouInstitut Régional du Cancer Montpellier, Val d'Aurelle, 34298 Montpellier, France.
Sophie Gourgou-BourgadeInstitut Régional du Cancer Montpellier, Val d'Aurelle, 34298 Montpellier, France.
Trevor StanburyR&D UNICANCER, 75013 Paris, France.
Laurent RocheCNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Service de Biostatistiques, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, 69495 Pierre-Bénite, France.
Brice OzenneCNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Service de Biostatistiques, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, 69495 Pierre-Bénite, France.
Marc BuyseInternational Drug Development Institute (IDDI), San Francisco, CA 94109, USA.
Centre National de la Recherche Scientifique · FRHospices Civils de Lyon · FRCentre Léon Bérard · FRInstitut de Cancérologie de Lorraine · FRInstitut de Recherche en Cancérologie de Montpellier · FRInstitut Regional du Cancer de MontpellierUniCancer Group · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe sought to assess the benefit-risk balance of FOLFIRINOX versus gemcitabine in patients with metastatic pancreatic adenocarcinoma.

methodsWe used generalized pairwise comparisons. This statistical method permits the simultaneous analysis of several prioritized outcome measures. The first priority outcome was survival time (OS). Differences in OS that exceeded two months were considered clinically relevant. The second priority outcome was toxicity. The overall treatment effect was quantified using the net chance of a better outcome, which can be interpreted as the net probability for a random patient treated in the FOLFIRINOX group to have a better overall outcome than a random patient in the gemcitabine group.

resultsIn this trial 342 patients received either FOLFIRINOX or gemcitabine. The net chance of a better outcome favored strongly and significantly the FOLFIRINOX group (24.7; P<.001), suggesting a favorable benefit-risk balance of FOLFIRINOX versus gemcitabine. The positive benefit-risk balance of FOLFIRINOX was observed throughout all sensitivity analyses.

conclusionsGeneralized pairwise comparisons are useful to perform a quantitative assessment of the benefit-risk balance of new treatments. It provides a clinically intuitive way of comparing patients with respect to all important efficacy and toxicity outcomes. Overall the benefit-risk balance of FOLFIRINOX was strongly positive.

Indexed as

AdenocarcinomaAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCamptothecinDeoxycytidineDisease-Free SurvivalDisease ProgressionFluorouracilGemcitabineHumansIrinotecanKaplan-Meier EstimateLeucovorinOrganoplatinum CompoundsOxaliplatinPancreatic NeoplasmsAntimetabolites, AntineoplasticCamptothecinDeoxycytidineFluorouracilGemcitabineIrinotecanLeucovorinOrganoplatinum CompoundsOxaliplatinbenefit-risk assessmentmulti-criteria analysispancreatic cancerrandomized controlled trialstatistics as topic

Identifiers

PMID27765912
PMCPMC5347744
OpenAlexW2539230415

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.