Evidence map›Paper›PMID 29022078›Full record

Trial reportJournal of cancer research and clinical oncology2018

Survival benefit of mantle cell lymphoma patients enrolled in clinical trials; a joint study from the LYSA group and French cancer registries.

Alix Augustin, Steven Le Gouill, Rémy Gressin, Aurélie Bertaut, Alain Monnereau, Anne-Sophie Woronoff, Brigitte Trétarre, Patricia Delafosse, Xavier Troussard, Anne Moreau and 2 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Alix AugustinRegistre des hémopathies malignes de Côte d'Or, Faculté des Sciences de Santé, Inserm UMR 1231, Université de Bourgogne F-Comté, 7 Bd Jeanne d'Arc, 21079, Dijon Cedex, France. alix_augustin@etu.u-bourgogne.fr.ORCID http://orcid.org/0000-0002-6006-1169
Steven Le GouillService Hématologie clinique, Centre Hospitalier Universitaire de de Nantes Hôtel-Dieu, Place Alexis Ricordeau, 44000, Nantes, France.
Rémy GressinService Hématologie clinique, Centre Hospitalier Universitaire de Grenoble Alpes CS 10217, 38043, Grenoble Cedex, France.
Aurélie BertautUnité de Méthodologie, Biostatistiques et Data Management, Centre George François Leclerc, 1 rue Pr Marion, 21000, Dijon, France.
Alain MonnereauRegistre des hémopathies malignes de la Gironde, Institut Bergonié, 229 Cours de l'Argonne, 33076, Bordeaux Cedex, France.
Anne-Sophie WoronoffRegistre des tumeurs du Doubs et du Territoire de Belfort, EA3181, CHU Besançon, 25030, Besançon Cedex, France.
Brigitte TrétarreRegistre des tumeurs de l'Hérault, ICM, Bât. Recherche Parc Euromédecine, 208 rue des Apothicaires, 34298, Montpellier Cedex 5, France.
Patricia DelafosseRegistre du Cancer de l'Isère, Centre Hospitalier Universitaire de Grenoble, BP 217, 38043, Grenoble Cedex 9, France.
Xavier TroussardRegistre Régional des hémopathies malignes de Basse Normandie, Centre Hospitalier Universitaire de Caen, Caen, France.
Anne MoreauService anatomie et cytologie pathologique, Centre Hospitalier Universitaire de Nantes Hôtel-Dieu, 44093, Nantes Cedex 1, France.
Olivier HermineDépartement d'hématologie, Immunologie, Infectiologie Hôpital Necker Assistance Publique, Hôpitaux de Paris, 75743, Paris, France.
Marc MaynadiéRegistre des hémopathies malignes de Côte d'Or, Faculté des Sciences de Santé, Inserm UMR 1231, Université de Bourgogne F-Comté, 7 Bd Jeanne d'Arc, 21079, Dijon Cedex, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMantle cell lymphoma (MCL) is a rare non-Hodgkin's lymphoma entity with a poor prognosis. Therapeutic advances have improved the survival of patients enrolled in clinical trials; however, their impact on patients outside clinical trials remains unclear. In this work, we compared patient outcome inside and outside clinical trials.

methodsWe identified MCL patients recorded in six French population-based registries between 2008 and 2012 to perform a comparison with patients enrolled in two prospective multicenter MCL clinical trials conducted by the LYSA group during the same period. Variables associated with inclusion in a clinical trial were identified using a logistic regression. Pohar-Perme estimator and Nelson et al. flexible parametric model was used to estimate net survival probabilities and prognosis factors on excess mortality.

resultsA total of 312 registry patients were compared to the 372 patients enrolled in LYSA clinical trials. Patients included in clinical trials were younger (median age 60 vs 74, p < 0.001). Age and Ann Arbor stage IV were independently associated with enrollment [OR = 0.09 (0.06-0.12) and OR = 1.61 (1.11-2.34), respectively]. The 4 year net survival was better in clinical trials [79.9% (75.9-84.7) vs 60.3% (53.6-67.0)]. This result was confirmed in multivariate analysis in patients older than 65 years with a lower excess mortality rate [0.33 (0.17-0.66)].

conclusionsMCL included in trials are highly selected patients who are not representative of MCL patients who are encountered in everyday practice. With widened inclusion criteria, clinical trial patients could be more representative of the general population.

Indexed as

AgedAge FactorsAntineoplastic Combined Chemotherapy ProtocolsCase-Control StudiesFemaleFranceHumansLymphoma, Mantle-CellMaleMiddle AgedNeoplasm StagingRegistriesClinical trial inclusionMantle cell lymphomaNon-Hodgkin’s lymphomaPopulation-based registryPrognostic factors

Identifiers

PMID29022078
PMCPMC11813506

What OpenQuestion holds

Textmetadata
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.