Format

Send to

Choose Destination
J Cancer Res Clin Oncol. 2018 Apr;144(4):629-635. doi: 10.1007/s00432-017-2529-9. Epub 2017 Oct 11.

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

Author information

1
Registre 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.
2
Service Hématologie clinique, Centre Hospitalier Universitaire de de Nantes Hôtel-Dieu, Place Alexis Ricordeau, 44000, Nantes, France.
3
Inserm CIRCNA, UMR892, Equipe 10, Nantes, France.
4
Service Hématologie clinique, Centre Hospitalier Universitaire de Grenoble Alpes CS 10217, 38043, Grenoble Cedex, France.
5
IAB, Institute for Advanced Biosciences Epigenetic and Genetic of Lymphoid Cancers Center Research UGA/Inserm U1209/CNRS UMR 4309, Grenoble, France.
6
Unité de Méthodologie, Biostatistiques et Data Management, Centre George François Leclerc, 1 rue Pr Marion, 21000, Dijon, France.
7
Registre des hémopathies malignes de la Gironde, Institut Bergonié, 229 Cours de l'Argonne, 33076, Bordeaux Cedex, France.
8
Registre des tumeurs du Doubs et du Territoire de Belfort, EA3181, CHU Besançon, 25030, Besançon Cedex, France.
9
Registre des tumeurs de l'Hérault, ICM, Bât. Recherche Parc Euromédecine, 208 rue des Apothicaires, 34298, Montpellier Cedex 5, France.
10
Registre du Cancer de l'Isère, Centre Hospitalier Universitaire de Grenoble, BP 217, 38043, Grenoble Cedex 9, France.
11
Registre Régional des hémopathies malignes de Basse Normandie, Centre Hospitalier Universitaire de Caen, Caen, France.
12
Service anatomie et cytologie pathologique, Centre Hospitalier Universitaire de Nantes Hôtel-Dieu, 44093, Nantes Cedex 1, France.
13
Département d'hématologie, Immunologie, Infectiologie Hôpital Necker Assistance Publique, Hôpitaux de Paris, 75743, Paris, France.
14
Registre 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.

Abstract

PURPOSE:

Mantle 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.

METHODS:

We 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.

RESULTS:

A 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)].

CONCLUSIONS:

MCL 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.

KEYWORDS:

Clinical trial inclusion; Mantle cell lymphoma; Non-Hodgkin’s lymphoma; Population-based registry; Prognostic factors

PMID:
29022078
DOI:
10.1007/s00432-017-2529-9
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Springer
Loading ...
Support Center