Evidence map›Paper›PMID 26010884›Full record

Trial reportPloS one2015

Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial.

Amélie Anota, Guillaume Mouillet, Isabelle Trouilloud, Anne-Claire Dupont-Gossart, Pascal Artru, Thierry Lecomte, Aziz Zaanan, Mélanie Gauthier, Francine Fein, Olivier Dubreuil and 3 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.1field-weighted citation impact, top 43% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. How scoring limits the usability of minimal important differences (MIDs) as responder definition (RD): an exemplary demonstration using EORTC QLQ-C30 subscales.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Article
  3. 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

13 authors at 7 institutions in 1 country.

Amélie AnotaNational Quality of Life in Oncology Platform, Besançon, France; Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
Guillaume MouilletMethodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
Isabelle TrouilloudDepartment of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
Anne-Claire Dupont-GossartDepartment of Gastroenterology, University Hospital of Besançon, Besançon, France.
Pascal ArtruHepato-Gastro-Enterology and Digestive Oncology Department, Hospital Jean Mermoz, Lyon, France.
Thierry LecomteDepartment of Gastroenterology and Digestive Oncology, University Hospital of Tours- Trousseau Hospital, Chambray-Les-Tours, France.
Aziz ZaananDepartment of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
Mélanie GauthierBiostatistics and Quality of Life Unit, Centre Georges François Leclerc, Dijon, France.
Francine FeinDepartment of Gastroenterology, University Hospital of Besançon, Besançon, France.
Olivier DubreuilDepartment of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
Sophie Paget-BaillyMethodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
Julien TaiebDepartment of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France.
Franck BonnetainNational Quality of Life in Oncology Platform, Besançon, France; Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France.
Methodology and Quality of Life Unit in Oncology · FRCentre Hospitalier Universitaire de Besançon · FRHôpital Européen Georges-Pompidou · FRUniversité Paris Cité · FRCentre Georges François Leclerc · FRHôpital Privé Jean Mermo · FRUniversité de Tours · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study.

methodsHRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS.

results98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21-0.59]) and pain (0.50 [0.31-0.81]) than those of Arm 1.

conclusionPatients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients' characteristics. TRIAL REGISTRATION INFORMATION: Eudract N° 2006-005703-34. (Name of the Trial: FIRGEM).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAdultAgedAntimetabolites, AntineoplasticDeoxycytidineFemaleGemcitabineHealth StatusHumansLiver NeoplasmsLongitudinal StudiesLung NeoplasmsMaleMiddle AgedMultivariate AnalysisPancreatic NeoplasmsAntimetabolites, AntineoplasticDeoxycytidineGemcitabine

Identifiers

PMID26010884
PMCPMC4444351
OpenAlexW2237833298

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.